CAREDX, INC., 10-K filed on 2/28/2024
Annual Report
v3.24.0.1
Cover Page - USD ($)
$ in Millions
12 Months Ended
Dec. 31, 2023
Feb. 26, 2024
Jun. 30, 2023
Cover [Abstract]      
Document Type 10-K    
Document Annual Report true    
Document Period End Date Dec. 31, 2023    
Current Fiscal Year End Date --12-31    
Document Transition Report false    
Entity File Number 001-36536    
Entity Registrant Name CAREDX, INC.    
Entity Incorporation, State or Country Code DE    
Entity Tax Identification Number 94-3316839    
Entity Address, Address Line One 8000 Marina Boulevard    
Entity Address, City or Town Brisbane    
Entity Address, State or Province CA    
Entity Address, Postal Zip Code 94005    
City Area Code 415    
Local Phone Number 287-2300    
Title of 12(b) Security Common Stock, par value $0.001 per share    
Trading Symbol CDNA    
Security Exchange Name NASDAQ    
Entity Well-known Seasoned Issuer No    
Entity Voluntary Filers No    
Entity Current Reporting Status Yes    
Entity Interactive Data Current Yes    
Entity Small Business false    
Entity Emerging Growth Company false    
ICFR Auditor Attestation Flag true    
Entity Shell Company false    
Document Financial Statement Error Correction Flag false    
Entity Public Float     $ 437.0
Entity Common Stock, Shares Outstanding   51,778,523  
Documents Incorporated by Reference Portions of the registrant’s Proxy Statement relating to the 2024 Annual Meeting of Stockholders, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such Proxy Statement, or an amendment to this Annual Report on Form 10-K, will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2023.    
Amendment Flag false    
Document Fiscal Year Focus 2023    
Document Fiscal Period Focus FY    
Entity Central Index Key 0001217234    
Entity Filer Category Accelerated Filer    
v3.24.0.1
Audit Information
12 Months Ended
Dec. 31, 2023
Audit Information [Abstract]  
Auditor Name Deloitte & Touche LLP
Auditor Location San Jose, California
Auditor Firm ID 34
v3.24.0.1
Consolidated Balance Sheets - USD ($)
Dec. 31, 2023
Dec. 31, 2022
Current assets:    
Cash and cash equivalents $ 82,197,000 $ 89,921,000
Marketable securities 153,221,000 203,168,000
Accounts receivable 51,061,000 66,312,000
Inventory 19,471,000 19,232,000
Prepaid and other current assets 7,763,000 9,216,000
Total current assets 313,713,000 387,849,000
Property and equipment, net 35,246,000 35,529,000
Operating leases right-of-use assets 29,891,000 34,689,000
Intangible assets, net 45,701,000 43,051,000
Goodwill 40,336,000 37,523,000
Restricted cash 586,000 522,000
Other assets 1,353,000 3,828,000
Total assets 466,826,000 542,991,000
Current liabilities:    
Accounts payable 12,872,000 9,942,000
Accrued compensation 19,703,000 16,902,000
Accrued and other liabilities 45,497,000 49,131,000
Total current liabilities 78,072,000 75,975,000
Deferred tax liability 136,000 0
Common stock warrant liability 0 32,000
Deferred payments for intangible assets 2,461,000 2,418,000
Operating lease liability, less current portion 28,278,000 33,406,000
Other liabilities 96,551,000 249,000
Total liabilities 205,498,000 112,080,000
Commitments and contingencies (Note 9)
Stockholders’ equity:    
Preferred stock: $0.001 par value; 10,000,000 shares authorized at December 31, 2023 and 2022; no shares issued and outstanding at December 31, 2023 and 2022 0 0
Common stock: $0.001 par value; 100,000,000 shares authorized at December 31, 2023 and 2022; 51,503,377 shares issued and outstanding at December 31, 2023; 53,583,301 shares issued and 53,533,250 shares outstanding at December 31, 2022 49,000 52,000
Additional paid-in capital 946,511,000 898,806,000
Accumulated other comprehensive loss (6,963,000) (7,503,000)
Accumulated deficit (678,269,000) (460,444,000)
Total stockholders’ equity 261,328,000 430,911,000
Total liabilities and stockholders’ equity $ 466,826,000 $ 542,991,000
Common stock, shares outstanding (in shares) 51,503,377 53,533,250
v3.24.0.1
Consolidated Balance Sheets (Parenthetical) - $ / shares
Dec. 31, 2023
Dec. 31, 2022
Statement of Financial Position [Abstract]    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 10,000,000 10,000,000
Preferred stock, shares issued (in shares) 0 0
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 100,000,000 100,000,000
Common stock, shares issued (in shares) 51,503,377 53,583,301
Common stock, shares outstanding (in shares) 51,503,377 53,533,250
v3.24.0.1
Consolidated Statements of Operations - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Revenues [Abstract]      
Total revenue $ 280,324 $ 321,793 $ 296,397
Operating expenses:      
Research and development 81,866 90,388 76,525
Sales and marketing 83,334 96,027 77,245
General and administrative 117,868 100,397 74,964
Restructuring costs 2,320 0 0
Litigation expense (Note 17) 96,300 0 0
Total operating expenses 483,687 399,024 326,123
Loss from operations (203,363) (77,231) (29,726)
Other income (expense):      
Interest income, net 11,867 3,762 160
Change in estimated fair value of common stock warrant liability 10 107 106
Other income (expense), net 1,343 (2,872) (2,628)
Total other income (expense) 13,220 997 (2,362)
Loss before income taxes (190,143) (76,234) (32,088)
Income tax (expense) benefit (141) (379) 1,426
Net loss $ (190,284) $ (76,613) $ (30,662)
Net loss per share (Note 3):      
Basic (in dollars per share) $ (3.54) $ (1.44) $ (0.59)
Diluted (in dollars per share) $ (3.54) $ (1.44) $ (0.59)
Weighted-average shares used to compute net loss per share:      
Basic (in shares) 53,764,705 53,321,625 52,241,076
Diluted (in shares) 53,764,705 53,321,625 52,241,076
Testing services revenue      
Revenues [Abstract]      
Total revenue $ 209,685 $ 263,748 $ 259,285
Operating expenses:      
Cost of testing services, product, patient and digital solutions 57,642 72,286 71,251
Product revenue      
Revenues [Abstract]      
Total revenue 33,517 29,251 26,832
Operating expenses:      
Cost of testing services, product, patient and digital solutions 18,379 17,639 18,930
Patient and digital solutions      
Revenues [Abstract]      
Total revenue 37,122 28,794 10,280
Operating expenses:      
Cost of testing services, product, patient and digital solutions $ 25,978 $ 22,287 $ 7,208
v3.24.0.1
Consolidated Statements of Comprehensive Loss - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Statement of Comprehensive Income [Abstract]      
Net loss $ (190,284) $ (76,613) $ (30,662)
Other comprehensive loss:      
Foreign currency translation adjustments, net of tax 540 (2,833) (2,574)
Net comprehensive loss $ (189,744) $ (79,446) $ (33,236)
v3.24.0.1
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity - USD ($)
$ in Thousands
Total
Common Stock
Additional Paid-In Capital
Accumulated Other Comprehensive Loss
Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2020   49,441,166      
Beginning balance at Dec. 31, 2020 $ 277,679 $ 49 $ 632,253 $ (2,096) $ (352,527)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common shares through public equity offering, net of commissions (in shares)   2,211,538      
Issuance of common shares through public equity offering, net of commissions 188,855 $ 2 188,853    
Contingent consideration classified as equity (222)   (222)    
Issuance of common stock under employee stock purchase plan (in shares)   45,464      
Issuance of common stock under employee stock purchase plan 2,139   2,139    
RSU settlements, net of shares withheld (in shares)   464,693      
RSU settlements, net of shares withheld (18,441)   (18,441)    
Issuance of common stock for services (in shares)   3,984      
Issuance of common stock for services 296   296    
Issuance of common stock for cash upon exercise of stock options (in shares)   753,383      
Issuance of common stock for cash upon exercise of stock options 12,776 $ 1 12,775    
Issuance of common stock for cash upon exercise of warrants (in shares)   3,132      
Issuance of common stock for cash upon exercise of warrants 205   205    
Employee stock-based compensation expense 35,825   35,825    
Foreign currency translation adjustment (2,574)     (2,574)  
Net loss (30,662)       (30,662)
Ending balance (in shares) at Dec. 31, 2021   52,923,360      
Ending balance at Dec. 31, 2021 465,876 $ 52 853,683 (4,670) (383,189)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common stock under employee stock purchase plan (in shares)   93,422      
Issuance of common stock under employee stock purchase plan 2,230   2,230    
Repurchase and retirement of common stock (in shares)   (50,051)      
Repurchase and retirement of common stock (642)       (642)
RSU settlements, net of shares withheld (in shares)   411,176      
RSU settlements, net of shares withheld (6,067)   (6,067)    
Issuance of common stock for services (in shares)   12,764      
Issuance of common stock for services 319   319    
Issuance of common stock for cash upon exercise of stock options (in shares)   142,579      
Issuance of common stock for cash upon exercise of stock options 2,435   2,435    
Employee stock-based compensation expense 46,206   46,206    
Foreign currency translation adjustment (2,833)     (2,833)  
Net loss $ (76,613)       (76,613)
Ending balance (in shares) at Dec. 31, 2022 53,533,250 53,533,250      
Ending balance at Dec. 31, 2022 $ 430,911 $ 52 898,806 (7,503) (460,444)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common stock under employee stock purchase plan (in shares)   190,841      
Issuance of common stock under employee stock purchase plan 1,495   1,495    
Repurchase and retirement of common stock (in shares)   (2,942,997)      
Repurchase and retirement of common stock (27,544) $ (3)     (27,541)
RSU settlements, net of shares withheld (in shares)   669,283      
RSU settlements, net of shares withheld (3,059)   (3,059)    
Issuance of common stock for services (in shares)   21,965      
Issuance of common stock for services $ 216   216    
Issuance of common stock for cash upon exercise of stock options (in shares) 27,903 27,903      
Issuance of common stock for cash upon exercise of stock options $ 120   120    
Issuance of common stock for cash upon exercise of warrants (in shares)   3,132      
Issuance of common stock for cash upon exercise of warrants 26   26    
Employee stock-based compensation expense 48,907   48,907    
Foreign currency translation adjustment 540     540  
Net loss $ (190,284)       (190,284)
Ending balance (in shares) at Dec. 31, 2023 51,503,377 51,503,377      
Ending balance at Dec. 31, 2023 $ 261,328 $ 49 $ 946,511 $ (6,963) $ (678,269)
v3.24.0.1
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Parenthetical)
$ in Thousands
12 Months Ended
Dec. 31, 2021
USD ($)
Statement of Stockholders' Equity [Abstract]  
Common stock, offering costs $ 12,495
v3.24.0.1
Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Operating activities:      
Net loss $ (190,284) $ (76,613) $ (30,662)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:      
Stock-based compensation 49,086 46,553 36,081
Asset impairments and write-downs 1,000 840 2,437
Depreciation and amortization 14,386 11,595 8,797
Amortization of right-of-use assets 5,438 4,412 3,088
Unrealized loss on long-term marketable equity securities 0 1,181 1,743
Realized gain on sale of long-term marketable equity securities, net (284) 0 0
Loss on disposal of asset 44 0 0
Gain on settlement of obligation and recovery of written-off investment (2,109) 0 0
Revaluation of common stock warrant liability to estimated fair value (10) (107) (106)
Revaluation of contingent consideration to estimated fair value 2,677 727 (609)
Accretion of discount and amortization of premium on short-term marketable securities, net (4,927) 390 1,129
Other non-cash items 0 0 (222)
Changes in operating assets and liabilities:      
Accounts receivable 16,016 (6,660) (24,416)
Inventory 54 (2,859) (6,927)
Prepaid and other assets 1,767 (1,049) (5,144)
Accounts payable 2,904 (2,054) 1,789
Accrued compensation 2,655 (9,251) 7,516
Accrued and other liabilities 89,608 11,327 10,690
Accrued royalties (1,557) 0 0
Operating lease liabilities, net (5,418) (3,456) (2,603)
Refund liability - CMS advance payment 0 0 (20,496)
Change in deferred taxes 566 (215) (1,379)
Net cash used in operating activities (18,388) (25,239) (19,294)
Investing activities:      
Maturities of short-term marketable securities 256,038 111,587 88,905
Purchases of short-term marketable securities (201,165) (315,145) 0
Purchases of long-term marketable securities 0 0 (5,500)
Purchase of corporate equity securities (965) 0 0
Proceeds from sale of equity securities 2,460 0 0
Additions of capital expenditures (8,344) (21,234) (13,559)
Acquisition of intangible assets (896) (3,100) (6,700)
Acquisition of business, net of cash acquired (6,682) (610) (15,434)
Net cash provided by (used in) investing activities 40,446 (228,502) 47,712
Financing activities:      
Proceeds from issuance of common shares 0 0 188,855
Payment of contingent consideration (625) (2,625) 0
Principal payments on finance lease obligations 0 0 (66)
Repurchase and retirement of common stock (27,541) (642) 0
Proceeds from exercise of warrants 4 0 4
Proceeds from exercise of stock options 120 2,435 12,775
Proceeds from issuance of common stock under employee stock purchase plan 1,495 2,230 2,139
Taxes paid related to net share settlement of restricted stock units (3,059) (5,933) (18,065)
Net cash (used in) provided by financing activities (29,606) (4,535) 185,642
Effect of exchange rate changes on cash and cash equivalents (112) 23 (303)
Net (decrease) increase in cash, cash equivalents and restricted cash (7,660) (258,253) 213,757
Cash, cash equivalents, and restricted cash at beginning of period 90,443 348,696 134,939
Cash, cash equivalents, and restricted cash at end of period 82,783 90,443 348,696
Supplemental disclosures of cash information      
Cash paid for interest 0 8 1
Cash paid for income taxes 738 392 14
Supplemental disclosures of cash flow information      
Shares issued in lieu of payment 216 319 296
Operating lease right-of-use assets 607 22,267 6,079
Purchases of capital expenditures in accounts payable and accrued liabilities 647 1,423 3,953
Employee stock purchase plan shares included in accrued compensation 556 686 1,521
Contingent consideration $ 3,499 $ 0 $ 5,341
v3.24.0.1
Organization and Description of Business
12 Months Ended
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization and Description of Business ORGANIZATION AND DESCRIPTION OF BUSINESS
CareDx, Inc. (“CareDx” or the “Company”), together with its subsidiaries, is a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers. The Company’s headquarters are in Brisbane, California. The primary operations are in Brisbane, California; Omaha, Nebraska; Fremantle, Australia; and Stockholm, Sweden.
The Company’s commercially available testing services consist of AlloSure® Kidney, a donor-derived cell-free DNA (“dd-cfDNA”) solution for kidney transplant patients, AlloMap® Heart, a gene expression solution for heart transplant patients, AlloSure® Heart, a dd-cfDNA solution for heart transplant patients, and AlloSure® Lung, a dd-cfDNA solution for lung transplant patients. The Company has initiated several clinical studies to generate data on its existing and planned future testing services. In April 2020, the Company announced its first biopharma research partnership for AlloCell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy transplants. The Company also offers high-quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. The Company also provides digital solutions to transplant centers following the acquisitions of Ottr Complete Transplant Management (“Ottr”) and XynManagement, Inc. (“XynManagement”), as well as the acquisitions of TransChart LLC (“TransChart”), MedActionPlan.com, LLC (“MedActionPlan”) and The Transplant Pharmacy, LLC (“TTP”) in 2021, HLA Data Systems, LLC (“HLA Data Systems”) in January 2023 and MediGO, Inc. (“MediGO”) in July 2023.
Testing Services
AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017 through a Local Coverage Determination (“LCD”), first issued by Palmetto MolDX (“MolDX”), which was formed to identify and establish coverage and reimbursement for molecular diagnostics tests, and then adopted by Noridian Healthcare Solutions, the Company’s Medicare Administrative Contractor (“Noridian”). The Medicare reimbursement rate for AlloSure Kidney is currently $2,841.
AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for AlloMap Heart is currently $3,240. In October 2020, the Company received a final MolDX Medicare coverage decision for AlloSure Heart. In November 2020, Noridian issued a parallel coverage policy granting coverage for AlloSure Heart when used in conjunction with AlloMap Heart, which became effective in December 2020. In 2021, Palmetto and Noridian issued coverage policies written by MolDX to replace the former product-specific policies. The foundational LCD is titled “MolDX: Molecular Testing for Solid Organ Allograft Rejection” and the associated LCD numbers are L38568 (MolDX) and L38629 (Noridian).The Medicare reimbursement rate for AlloSure Heart is currently $2,753. Effective May 9, 2023, AlloSure Lung is covered for Medicare beneficiaries through the same MolDX LCD (Noridian L38629). The Medicare reimbursement rate for AlloSure Lung is $2,753. Effective April 1, 2023, HeartCare, a multimodality testing service that includes both AlloMap Heart and AlloSure Heart provided in a single patient encounter for heart transplant surveillance, is covered, subject to certain limitations, for Medicare beneficiaries through the same MolDX LCD (Noridian L38629). The Medicare reimbursement rate for HeartCare is $5,993.
AlloSure Kidney has received positive coverage decisions from several commercial payers, and is reimbursed by other private payers on a case-by-case basis. AlloMap Heart has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers.
In May 2021 and March 2023, the Company purchased a minority investment of common stock in the biotechnology company Miromatrix Medical, Inc. (“Miromatrix”) for an aggregate amount of $5.1 million, and the investment is marked to market. Miromatrix works to eliminate the need for an organ transplant waiting list through the development of implantable engineered biological organs. In December 2023, Miromatrix was acquired by United Therapeutics Corporation.
Clinical Studies
In January 2018, the Company initiated the Kidney Allograft Outcomes AlloSure Kidney Registry study (“K-OAR”) to develop additional data on the clinical utility of AlloSure Kidney for surveillance of kidney transplant recipients. K-OAR is a multicenter, non-blinded, prospective observational cohort study which has enrolled more than 1,900 renal transplant patients who will receive AlloSure Kidney long-term surveillance.
In September 2018, the Company initiated the Surveillance HeartCare Outcomes Registry (“SHORE”). SHORE is a prospective, multi-center, observational registry of patients receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure® Heart in one surveillance solution.
In September 2019, the Company announced the commencement of the Outcomes of KidneyCare on Renal Allografts (“OKRA”) study, which is an extension of K-OAR. OKRA is a prospective, multi-center, observational, registry of patients receiving KidneyCare for surveillance. KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap Kidney and the predictive artificial intelligence technology of iBox for a multimodality surveillance solution. The Company has not yet made any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare.
In December 2021, the Company initiated the ALAMO study. ALAMO is a multicenter observational study and focuses on surveillance in lung transplant recipients within the first post-transplant year. Beyond demonstrating the clinical validity of AlloSure in detecting Acute Lung Allograft Dysfunction, a composite outcome of acute rejection and clinically meaningful infections, the study explores its clinical utility by capturing clinician decision-making processes to further demonstrate the practical clinical application of AlloSure. In addition, the study will collect samples to enable development of AlloMap Lung.
Products
The Company’s suite of AlloSeq products are commercial next generation sequencing (“NGS”)-based kitted solutions. These products include: AlloSeq Tx, a high-resolution Human Leukocyte Antigen (“HLA”) typing solution, AlloSeq cfDNA, a surveillance solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq HCT, a solution for chimerism testing for stem cell transplant recipients.
The Company's other HLA typing products include: Olerup SSP®, based on the sequence specific primer (“SSP”) technology; and QTYPE®, which uses real-time polymerase chain reaction (“PCR”) methodology, to perform HLA typing.
In March 2021, the Company acquired certain assets of BFS Molecular S.R.L. (“BFS Molecular”), a software company focused on NGS-based patient testing solutions. BFS Molecular brings extensive software and algorithm development capabilities for NGS transplant surveillance products.
Patient and Digital Solutions
Following the acquisitions of both Ottr and XynManagement, the Company is a leading provider of transplant patient management software (“Ottr software”), as well as of transplant quality tracking and waitlist management solutions. Ottr software provides comprehensive solutions for transplant patient management and enables integration with electronic medical record (“EMR”) systems providing patient surveillance management tools and outcomes data to transplant centers. XynManagement provides two unique solutions, XynQAPI software (“XynQAPI”) and XynCare. XynQAPI simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting. XynCare includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility.
In September 2020, the Company launched AlloCare, a mobile app that provides a patient-centric resource for transplant recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health metrics.
In January 2021, the Company acquired TransChart. TransChart provides EMR software to hospitals throughout the U.S. to care for patients who have or may need an organ transplant. As part of the Company’s acquisition of TransChart in January 2021, the Company acquired TxAccess, a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs and closely follow and assist patients through the transplant waitlist process and, ultimately, through transplantation.
In June 2021, the Company acquired the Transplant Hero patient application. The application helps patients manage their medications through alarms and interactive logging of medication events.
Also in June 2021, the Company entered into a strategic agreement with OrganX, which was amended in April 2022, to develop clinical decision support tools across the transplant patient journey. Together, the Company and OrganX will develop advanced analytics that integrate AlloSure with large transplant databases to provide clinical data solutions. This partnership delivers the next level of innovation by incorporating a variety of clinical inputs to create a universal composite scoring system. The Company has agreed to potential future milestone payments.
In November 2021, the Company acquired MedActionPlan, a New Jersey-based provider of medication safety, medication adherence and patient education. MedActionPlan is a leader in patient medication management for transplant patients and beyond.
In December 2021, the Company acquired TTP, a transplant-focused pharmacy located in Mississippi. TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S.
In January 2023, the Company acquired HLA Data Systems, a Texas-based company that provides software and interoperability solutions for the histocompatibility and immunogenetics community. HLA Data Systems is a leader in the laboratory information management industry for human leukocyte antigen laboratories.
In July 2023, the Company acquired MediGO, an organ transplant supply chain and logistics company. MediGO provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization.
Liquidity and Capital Resources
The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $678.3 million at December 31, 2023. As of December 31, 2023, the Company had cash and cash equivalents and marketable securities of $235.4 million and no debt outstanding.
Shelf Registration Statement
On May 10, 2023, the Company filed a universal shelf registration statement (File No. 333-271814) (the “Registration Statement”), whereby the Company can sell from time to time up to $250.0 million of shares of its common stock, preferred stock, debt securities, warrants, units or rights comprised of any combination of these securities, for the Company’s own account in one or more offerings under the Registration Statement. The terms of any offering under the Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the Registration Statement filed with the Securities and Exchange Commission (the “SEC”) prior to the completion of any such offering.
Stock Repurchase Program
On December 3, 2022, the Company's Board of Directors approved a stock repurchase program (the "Repurchase Program"), whereby the Company may purchase up to $50 million of shares of its common stock over a period of up to two years, commencing on December 8, 2022. The Repurchase Program may be carried out at the discretion of a committee of the Company's Board of Directors through open market purchase, one or more Rule 10b5-1 trading plans and block trades and in privately negotiated transactions. During the year ended December 31, 2023, the Company purchased an aggregate of 2,942,997 shares of its common stock under the Repurchase Program for an aggregate purchase price of $27.5 million. As of December 31, 2023, $21.9 million remained available for future repurchase under the Repurchase Program.
v3.24.0.1
Summary of Significant Accounting Policies
12 Months Ended
Dec. 31, 2023
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its subsidiaries. Intercompany transactions have been eliminated.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; standalone fair value of patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of assets and liabilities acquired in a business combination or an asset acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination or an asset acquisition; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to credit risk consist of cash, cash equivalents, marketable securities and accounts receivable. The Company’s policy is to invest its cash and cash equivalents in money market funds, obligations of U.S. government agencies and government-sponsored entities, commercial paper, corporate debt securities and various bank deposit accounts. The counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit standing. The Company is exposed to credit risk in the event of default by the financial institutions to the extent of amounts recorded on the balance sheets that may be in excess of insured limits.
The Company is also subject to credit risk from its accounts receivable, which are derived from revenue earned from AlloSure Kidney, AlloSure Heart and AlloMap Heart tests provided for patients located in the U.S. and Canada, and billed to various third-party payers, from sales of products to distributors, strategic partners and transplant laboratories in Europe, Asia, the Middle East, Africa, the U.S., Latin America and other geographic regions, from sales of patient and digital solutions software. The Company has not experienced any significant credit losses and does not require collateral on receivables. For the years ended December 31, 2023, 2022 and 2021, approximately 40%, 53% and 59%, respectively, of total revenue was billed to Medicare. No other payers represented more than 10% of total revenue for the years ended December 31, 2023, 2022 and 2021.
As of December 31, 2023 and 2022, approximately 36% and 27%, respectively, of accounts receivable was due from Medicare. No other payer represented more than 10% of accounts receivable at either December 31, 2023 or 2022.
Cash and Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase. Cash equivalents consist primarily of amounts invested in money market funds.
Restricted Cash
As a condition of the lease agreements for certain facilities the Company must maintain letters of credit and certain minimum collateral requirements. The cash used to support these arrangements of $0.6 million is classified as long-term restricted cash on the accompanying consolidated balance sheets.
Marketable Securities
The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of December 31, 2023, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase, which were classified as current assets on the consolidated balance sheet.
The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net, on the consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification.
The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of December 31, 2023, the Company’s long-term marketable securities consisted of corporate equity securities. These long-term marketable securities are classified as other assets on the consolidated balance sheet.
The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other income (expense), net, on the consolidated statements of operations.
Inventory
Inventory is finished goods, work in progress, and raw materials and consists of reagent plates, laboratory supplies, reagents and finished goods kits. Inventories are used in connection with tests performed, kits produced and prescription drugs, and may also be used for research and product development efforts. Laboratory supplies subsequently designated for research and product development use are expensed. Obsolete or damaged inventories are written off. Certain inventories are stated at the lower of purchased cost, determined on an average cost basis, or net realizable value. Inventories are stated at the lower of actual purchased cost, determined on an average cost basis, on a first-in, first-out basis, or at net realizable value.
Property and Equipment, net
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. The estimated useful life is generally three to five years for computer, office and laboratory equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remaining lease term.
The Company capitalizes certain costs incurred for software developed or obtained for internal use, including hosting arrangements. These costs include software licenses and consulting services, as well as employee payroll and payroll-related costs. Capitalized internal-use software costs are usually amortized over a period of three to seven years.
Business Combinations
The Company determines and allocates the purchase price of an acquired business to the assets acquired and liabilities assumed based on their estimated fair values as of the business combination date, including separately identifiable intangible assets, which are separable from goodwill. The Company bases the estimated fair value of identifiable intangible assets acquired in a business combination on independent valuations that use information and assumptions provided by management, which consider management’s best estimates of inputs and assumptions that a market participant would use. The Company allocates any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities assumed to goodwill. The use of alternative valuation assumptions, including estimated revenue projections, growth rates, royalty rates, cash flows, discount rates, estimated useful lives and probabilities surrounding the achievement of contingent milestones could result in different purchase price allocations and amortization expense in current and future periods.
In those circumstances where an acquisition involves a contingent consideration arrangement that meets the definition of a liability under Accounting Standard Codification (“ASC”), Topic 480, Distinguishing Liabilities from Equity, the Company recognizes a liability equal to the fair value of the contingent payments that the Company expects to make as of the acquisition date. The Company remeasures this liability each reporting period and records changes in the fair value as a component of operating expenses. In circumstances where the contingent consideration is classified as equity, the Company recognizes it at fair value at the acquisition date. Contingent consideration classified as equity is not subsequently remeasured.
Transaction costs associated with acquisitions are expensed as incurred in general and administrative expenses. Results of operations and cash flows of acquired companies are included in the Company’s operating results from the date of acquisition.
Acquired Intangible Assets
Amortizable intangible assets include customer relationships, developed technology, commercialization rights, trademarks and in-process technology assets acquired as part of a business combination or asset acquisition. Intangible assets subject to amortization are amortized over their estimated useful lives. Acquired in-process technology assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time.
Impairment of Goodwill, Intangible Assets and Long-lived Assets
Goodwill
Goodwill recorded in a business combination is not subject to amortization. Instead, it is tested for impairment on an annual basis and whenever events or changes in circumstances indicate its carrying amount may not be recoverable.
The Company’s annual impairment test date is December 1st. A qualitative assessment is initially made to determine whether it is necessary to perform a quantitative assessment. A qualitative assessment includes, among others, consideration of: (i) past, current and projected future earnings; (ii) recent trends and market conditions; and (iii) valuation metrics involving similar companies that are publicly-traded and acquisitions of similar companies, if available. If this qualitative assessment indicates that it is more likely than not that an impairment exists, or if the Company decides to bypass this option, it proceeds to the quantitative assessment. The quantitative assessment consists of a comparison between the estimated fair value of the Company’s reporting unit and its respective carrying amount including goodwill. Where the carrying value of the reporting unit exceeds its estimated fair value, the Company will record an impairment charge based on that difference. The impairment charge will be limited to the amount of goodwill allocated to that reporting unit.
When necessary, to determine the reporting unit’s fair value under the quantitative approach, the Company uses a combination of income and market approaches, such as estimated discounted future cash flows of that reporting unit, multiples of earnings or revenues, and analysis of recent sales or offerings of comparable entities. The Company also considers its market capitalization on the date of the analysis to ensure the reasonableness of the reporting unit’s fair value.
In connection with the Company’s annual goodwill assessment on December 1, 2023, the Company performed a qualitative assessment taking into consideration past, current and projected future earnings, recent trends and market conditions; and the Company's market capitalization. Based on this analysis, the Company concluded that it was more likely than not that the fair value of the reporting unit exceeded its carrying amount. As such, it was not necessary to perform the quantitative goodwill impairment assessment at that time. As of December 31, 2023, no impairment of goodwill has been identified.
Intangible assets not subject to amortization
The Company evaluates the carrying value of intangible assets not subject to amortization, related to acquired in-process technology assets and a favorable license agreement, which are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. Accordingly, amortization of the acquired in-process technology assets and the favorable license agreement will not occur until the products reach commercialization.
During the period the assets are considered indefinite-lived, they are tested for impairment on an annual basis, as well as between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate that the fair value of the acquired in-process technology assets and the favorable license agreement are less than their carrying amounts. An impairment loss would be recorded when the fair value of an acquired in-process technology asset and the favorable license agreement are less than the carrying value. If and when development is complete, which generally occurs when the products are made commercially available, the associated acquired in-process technology asset and the favorable license agreement will be deemed finite-lived and will then be amortized based on the estimated useful life.
As of December 31, 2023, no impairment of acquired in-process technology assets and the favorable license agreement has been identified.
Intangible assets and long-lived assets subject to amortization
The Company evaluates its finite-lived intangible assets and its long-lived assets for indicators of possible impairment when events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company then compares the carrying amounts of the assets with the future net undiscounted cash flows expected to be generated by such asset. If an impairment exists, the Company measures the impairment based on the excess carrying value of the asset over the asset’s fair value determined using discounted estimates of future cash flows. The Company has not identified any material impairment losses to date.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received from selling an asset or the price paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which the Company would transact, and it takes into consideration the assumptions that market participants would use when pricing the asset or liability. The Company’s assessment of the significance of a particular input to the fair value measurement of an asset or liability requires management to make judgments and to consider specific characteristics of that asset or liability.
The carrying amounts of certain financial instruments of the Company, including cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their short maturities. The carrying amount of the contingent consideration liability also represents its fair value.
Leases
The Company adopted ASC Topic 842, Leases (“ASC 842”) and determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. The Company also has lease arrangements with lease and non-lease components. The Company elected the practical expedient not to separate non-lease components from lease components for the Company's facility leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for leases with an initial term of 12 months or less.
The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment.
As of December 31, 2023, the Company’s leases had remaining terms of 0.42 years to 9.09 years, some of which include options to extend the lease term.
Revenue
The Company recognizes revenue from testing services, product sales, and patient and digital solutions revenue in the amount that reflects the consideration that it expects to be entitled in exchange for goods or services as it transfers control to its
customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
Testing Services Revenue
AlloSure Kidney, AlloMap Heart, AlloSure Heart and AlloSure Lung patient tests are ordered by healthcare providers. The Company receives a test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to be its customer and the test requisition form to be the contract. Testing services are performed in the Company’s laboratory. Testing services represent one performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a point in time.
The healthcare providers that order the tests and on whose behalf the Company provides testing services are generally not responsible for the payment of these services. The first and second revenue recognition criteria are satisfied when the Company receives a test requisition form with payer information from the healthcare provider. Generally, the Company bills third-party payers upon delivery of an AlloSure Kidney, AlloMap Heart, AlloSure Heart or AlloSure Lung test result to the healthcare provider. Amounts received may vary amongst payers based on coverage practices and policies of the payer. The Company has used the portfolio approach under ASC Topic 606, Revenue from Contracts with Customers, to identify financial classes of payers. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where applicable. The Company estimates revenue for non-contracted payers and self-payers using transaction prices determined for each financial class of payers using history of reimbursements. This includes analysis of an average reimbursement per test and a percentage of tests reimbursed. This estimate requires significant judgment.
The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates.
In March and May 2023, MolDX issued new billing articles related to the LCD entitled Molecular Testing for Solid Organ Allograft Rejection. The billing article issued in May 2023 (the “Revised Billing Article”) and together with the billing article issued in March 2023 (the “Billing Articles”) impacted Medicare coverage for AlloSure Kidney, AlloSure Heart, AlloMap Heart and AlloSure Lung, and required certain companies, including the Company, to implement new processes to address the requirements related to Medicare claim submissions. Noridian adopted the Revised Billing Article on August 17, 2023, with a retroactive effective date of March 31, 2023.
Although the Company believes the Billing Articles are inconsistent with the LCDs, Noridian’s and MolDX’s responses to public comments explaining the intended scope of various LCDs, and medical necessity, the Company determined to pause its Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 to allow the Company further time to evaluate the implications of the Billing Article and update the Company's billing processes for AlloSure Kidney tests by educating clinicians and working with centers to update the Company's test order forms to capture the new information required under the Billing Article. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million (the “Impacted March Tests”).
On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) its belief that the Billing Articles impose new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which it had not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023.
The Company continued the Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, the Company informed Noridian on May 18, 2023 that until Noridian adopts the Revised Billing Article, the Company would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart according to requirements of the Billing Article currently effective at Noridian. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, the Company plans to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing
Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article.
On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims.
On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian respectively. The Company also submitted written comments on the proposed draft LCD.
Product Revenue
Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied. The Company generally has a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and the risk of loss is passed to the customer upon either shipping or delivery, as per the terms of the agreement.
Patient and Digital Solutions Revenue
Patient and digital solutions revenue is mainly derived from a combination of software as a service (“SaaS”) and perpetual software license agreements entered into with various transplant centers, which are the Company’s customers for this class of revenue. The main performance obligations in connection with the Company’s SaaS and perpetual software license agreements are the following: (i) implementation services and delivery of the perpetual software license, which are considered a single performance obligation, and (ii) post contract support. The Company allocates the transaction price to each performance obligation based on relative stand-alone selling prices of each distinct performance obligation. Digital revenue in connection with perpetual software license agreements is recognized over time based on the Company’s satisfaction of each distinct performance obligation in each agreement.
Perpetual software license agreements typically require advance payments from customers upon the achievement of certain milestones. The Company records deferred revenue in relation to these agreements when cash payments are received or invoices are issued in advance of the Company’s performance, and generally recognizes revenue over the contractual term, as performance obligations are fulfilled.
In addition, the Company derives patient and digital solutions revenue from software subscriptions and medication sales. The Company generally bills software subscription fees in advance. Revenue from software subscriptions is deferred and recognized ratably over the subscription term. The medication sales revenue is recognized based on the negotiated contract price with the governmental, commercial and non-commercial payers with any applicable patient co-pay. The Company recognizes revenue from medication sales when prescriptions are delivered.
Cost of Testing Services
Cost of testing services reflects the aggregate costs incurred in delivering the Company’s testing services. The components of cost of testing services are materials and service costs, direct labor costs, stock-based compensation, equipment and infrastructure expenses associated with testing samples, shipping, logistics and specimen processing charges to collect and transport samples, and allocated overhead including rent, information technology, equipment depreciation, utilities and royalties. Royalties for licensed technology, calculated as a percentage of testing services revenues, are recorded as license fees in cost of testing services at the time the testing services revenues are recognized.
Cost of Product
Cost of product reflects the aggregate costs incurred in delivering the Company’s products to customers. The components of cost of product are materials costs, manufacturing and kit assembly costs, direct labor costs, equipment and infrastructure expenses associated with preparing kitted products for shipment, shipping, and allocated overhead including rent, information technology, equipment depreciation and utilities. Cost of product also includes amortization of acquired developed technology and adjustments to inventory values, including write-downs of impaired, slow moving or obsolete inventory.
Cost of Patient and Digital Solutions
Cost of patient and digital solutions primarily consists of personnel-related costs associated with developing, installing and maintaining software, depreciation of servers and equipment, amortization of acquired intangible assets, support of the functionality of the software's platforms, including stock-based compensation expenses, cost of prescription drugs and allocated costs of facilities and information technology.
Research and Development Expenses
Research and development expenses, including clinical operations, represent costs incurred to develop diagnostic products and services, high quality evidence to support use of the Company’s tests, as well as continued efforts related to improving the Company’s existing products and patient and digital solutions service lines. These expenses include payroll and related expenses, consulting expenses, laboratory supplies, clinical studies and certain allocated expenses as well as amounts incurred under certain collaborative agreements. Research and development costs are expensed as incurred. The Company records accruals for estimated study costs comprised of work performed by contract research organizations under contract terms.
Stock-based Compensation
The Company uses the Black-Scholes Model, which requires the use of estimates such as stock price volatility and expected option lives, to value employee stock options. The Company estimates the expected option lives using historical data, estimates volatility using its own historical stock prices, estimates risk-free rates using the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected option lives, and estimates dividend yield using the Company’s expectations and historical data. The fair value of each restricted stock unit is calculated based upon the closing price of the Company’s common stock on the date of the grant.
The Company uses the straight-line attribution method for recognizing compensation expense. Compensation expense is recognized on awards ultimately expected to vest and reduced for forfeitures that are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based on the Company’s historical experience.
Compensation expense for stock options issued to nonemployees is calculated using the Black-Scholes Model and is recorded over the service performance period using the straight-line attribution method. Options subject to vesting are required to be periodically remeasured over their service performance period, which is generally the same as the vesting period.
Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. The Company’s assessment of an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit may change as new information becomes available.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiaries is the local currency for each entity, including the Swedish Krona, Australian dollar and the Euro. The revenue and expenses of such subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the
balance sheet date. The resulting cumulative translation adjustments are reported in other comprehensive loss. Foreign currency translation gains and losses on revenue and expenses are recognized in the consolidated statements of operations.
Comprehensive Loss
Comprehensive loss consists of net loss and other losses affecting stockholders’ equity that, under U.S. GAAP, are excluded from net income or loss. For the Company, such items consist of foreign currency losses on the translation of foreign assets and liabilities.
Recent Accounting Pronouncements
There were no recently adopted accounting standards which would have a material effect on the Company’s consolidated financial statements and accompanying disclosures, and no recently issued accounting standards that are expected to have a material impact on the Company’s consolidated financial statements and accompanying disclosures.
Effective in Future Periods
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosure of significant segment expenses. All current annual disclosures about a reportable segment’s profit or loss and assets will also be required in interim periods. The new guidance also requires disclosure of the title and position of the Chief Operating Decision Maker (“CODM”) and explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. The amendments set forth in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption of the amendments is permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements. This ASU will be effective for the Company’s annual disclosures in fiscal year 2024 and interim-period disclosures in fiscal year 2025. As the amendments only relate to disclosures, there will be no impact on the Company’s financial position or results of operations.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 340): Improvements to Income Tax Disclosures, which requires annual disclosures in the rate reconciliation table to be presented using both percentages and reporting currency amounts, and this table must include disclosure of specific categories. Additional information will also be required for reconciling items that meet a quantitative threshold. The new guidance also requires enhanced disclosures of income taxes paid, including the amount of income taxes paid disaggregated by federal, state and foreign taxes and the amount of income taxes paid disaggregated by individual jurisdictions that exceed a quantitative threshold. The amendments should be applied on a prospective basis, but retrospective application is permitted. The amendments set forth in this ASU are effective for annual periods beginning after December 15, 2024 for public entities. This guidance will be effective for the Company’s annual disclosures in fiscal year 2025. As the amendments only relate to disclosures, there will be no impact on the Company’s financial position or results of operations.
v3.24.0.1
Net Loss Per Share
12 Months Ended
Dec. 31, 2023
Earnings Per Share [Abstract]  
Net Loss Per Share NET LOSS PER SHARE
Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive.
For the years ended December 31, 2023, 2022 and 2021, all common share equivalents have been excluded from the calculation of diluted net loss per share, as their effect would be antidilutive.
The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data):
 Year Ended December 31,
 202320222021
Numerator:   
Net loss used to compute basic net loss per share
$(190,284)$(76,613)$(30,662)
Net loss used to compute diluted net loss per share
$(190,284)$(76,613)$(30,662)
Denominator:
Weighted-average shares used to compute basic net loss per share
53,764,705 53,321,625 52,241,076 
Weighted-average shares used to compute diluted net loss per share
53,764,705 53,321,625 52,241,076 
Net loss per share:
Basic$(3.54)$(1.44)$(0.59)
Diluted$(3.54)$(1.44)$(0.59)
The following potentially dilutive securities have been excluded from diluted net loss per share because their effect would be antidilutive:
Year Ended December 31,
202320222021
Shares of common stock subject to outstanding options
3,055,208 2,921,925 1,863,633 
Shares of common stock subject to outstanding common stock warrants
— 3,132 3,132 
Restricted stock units5,001,370 3,092,467 2,047,657 
Total common stock equivalents8,056,578 6,017,524 3,914,422 
On January 25, 2021 and February 11, 2021, the Company completed an underwritten public offering, including the sale of shares pursuant to the exercise of the underwriters' over-allotment option, pursuant to which the Company sold 1,923,077 and 288,461 shares of common stock, respectively.
v3.24.0.1
Fair Value Measurements
12 Months Ended
Dec. 31, 2023
Fair Value Disclosures [Abstract]  
Fair Value Measurements FAIR VALUE MEASUREMENTS
The Company records its financial assets and liabilities at fair value. The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities.
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The following table sets forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of December 31, 2023 and 2022 (in thousands):
December 31, 2023
Fair Value Measured Using
(Level 1)(Level 2)(Level 3)Total Balance
Assets
Cash equivalents:
Money market funds$60,525 $— $— $60,525 
Total$60,525 $— $— $60,525 
Liabilities
Short-term liabilities:
Contingent consideration$— $— $5,469 $5,469 
Long-term liabilities:
Contingent consideration— — 2,461 2,461 
Total$— $— $7,930 $7,930 
December 31, 2022
Fair Value Measured Using
(Level 1)(Level 2)(Level 3)Total Balance
Assets
Cash equivalents:
Money market funds$66,594 $— $— $66,594 
Long-term marketable securities:
Corporate equity securities2,076 — — 2,076 
Total$68,670 $— $— $68,670 
Liabilities
Short-term liabilities:
Contingent consideration$— $— $1,025 $1,025 
Long-term liabilities:
Contingent consideration— — 2,418 2,418 
Common stock warrant liability— — 32 32 
Total $— $— $3,475 $3,475 
The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):
(Level 3)
Common Stock Warrant Liability and Contingent Consideration
Balance at December 31, 2021
$5,480 
Change in estimated fair value of common stock warrant liability(107)
Additions to contingent consideration727 
Payment related to contingent consideration(2,625)
Balance at December 31, 2022
3,475 
Exercise of warrants(22)
Change in estimated fair value of common stock warrant liability(10)
Change in estimated fair value of contingent consideration on business combination
2,677 
Change in estimated fair value of contingent consideration on asset acquisition
166 
Additions to contingent consideration2,269 
Payment related to contingent consideration(625)
Balance at December 31, 2023
$7,930 
During March 2023, the Company wrote off $1.0 million of its investment in convertible preferred shares of Cibiltech SAS (“Cibiltech”), which was carried at cost. Cibiltech’s operations have been liquidated. The fair value of this investment was based on Level 3 inputs.
In July 2023, the Company entered into a Securities Holders’ Agreement (the “Agreement”) with a private entity based in France. The private entity was established to continue Cibiltech's activity, which consists of designing, developing, publishing, promoting, distributing, and marketing of software related to predictive solutions, to monitoring and/or to remote monitoring in the field of human organ allotransplantation, allografting, and chronic organ diseases. The private entity retained all assets of Cibiltech, including its licenses. Pursuant to the Agreement, the Company agreed to invest a certain amount in the private entity, in order to continue the commercialization of the iBox technology. The Company's investment is in the form of ordinary and Class B shares carried at cost. This investment is not considered material to the Company's consolidated financial statements.
In December 2023, Miromatrix was acquired by United Therapeutics Corporation. The Company tendered and sold all of its shares of Miromatrix to United Therapeutics Corporation for $2.5 million. The Company recognized a $1.5 million gain from the disposal of its Miromatrix shares and recorded as other income (expense), net, on the consolidated statements of operations for the year ended December 31, 2023.
In determining fair value, the Company uses various valuation approaches within the fair value measurement framework. The valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation hierarchy are summarized below:
Money market funds— Investments in money market funds are classified within Level 1. Money market funds are valued at the closing price reported by the fund sponsor from an actively traded exchange. At December 31, 2023 and 2022, money market funds were included as cash and cash equivalents in the consolidated balance sheets.
Long-term marketable equity and debt securities – Investments in long-term marketable equity securities are classified within Level 1. The securities are recorded at fair value based on readily available quoted market prices in active markets. The securities are recorded at fair value based on observable inputs for quoted prices for identical or similar assets in markets that are not active. Long-term marketable securities are located within other assets on the consolidated balance sheets.
Contingent consideration Contingent consideration is classified within Level 3. Contingent consideration relates to asset acquisitions and business combinations. The Company recorded the estimate of the fair value of the contingent consideration based on its evaluation of the probability of the achievement of the contractual conditions that would result in the payment of the contingent consideration. Contingent consideration was estimated using the fair value of the milestones to be paid if the contingency is met based on management’s estimate of the probability of success and projected revenues for revenue-based considerations at discounted rates ranging from 6% and 12% at December 31, 2023 and 12% at December 31, 2022. The significant input in the Level 3
measurement that is not supported by market activity is the Company’s probability assessment of the achievement of the milestones. The value of the liability is subsequently remeasured to fair value at each reporting date, and the change in estimated fair value is recorded as income or expense within operating expenses in the consolidated statements of operations until the milestones are paid, expire or are no longer achievable. Increases or decreases in the estimation of the probability percentage result in a directionally similar impact to the fair value measurement of the contingent consideration liability. The carrying amount of the contingent consideration liability represents its fair value.
Common stock warrant liability – Common stock warrant liability is classified within Level 3. The Company utilizes intrinsic value to estimate the fair value of the warrants. The intrinsic value is computed as the difference between the fair value of the Company’s common stock on the valuation date and the exercise price of the warrants. Increases (decreases) in the Company’s stock price discussed above result in a directionally similar impact to the fair value of the common stock warrant liability.
v3.24.0.1
Cash and Marketable Securities
12 Months Ended
Dec. 31, 2023
Cash and Cash Equivalents [Abstract]  
Cash and Marketable Securities CASH AND MARKETABLE SECURITIES
Cash, Cash Equivalents and Restricted Cash
A reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets to the amount reported within the consolidated statements of cash flows is shown in the table below (in thousands):
December 31, 2023December 31, 2022December 31, 2021
Cash and cash equivalents$82,197 $89,921 $348,485 
Restricted cash586 522 211 
Total cash, cash equivalents, and restricted cash at the end of the period$82,783 $90,443 $348,696 
Marketable Securities
All short-term marketable securities were considered held-to-maturity at December 31, 2023. At December 31, 2023, some of the Company’s short-term marketable securities were in an unrealized loss position. The Company determined that it had the positive intent and ability to hold until maturity all short-term marketable securities that have been in a continuous loss position, thus there was no recognition of any other-than-temporary impairment at December 31, 2023. All short-term marketable securities with unrealized losses as of the balance sheet date have been in a loss position for less than twelve months. Contractual maturities of the short-term marketable securities were within one year or less.
The long-term marketable equity securities were recorded in the consolidated balance sheets at fair market value with changes in the fair value recognized in earnings at December 31, 2023. The long-term marketable debt securities were considered available-for-sale. The contractual maturity of the long-term marketable debt securities are less than three years. During 2022, the Company wrote off $0.5 million of long-term marketable debt securities.
The amortized cost, gross unrealized holding losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the table below (in thousands):
December 31, 2023
Amortized Cost
Unrealized Holding Gains
Fair Value
Short-term marketable securities:
U.S. agency securities$80,468 $2,038 $82,506 
Corporate debt securities72,753 711 73,464 
Total short-term marketable securities153,221 2,749 155,970 
Total $153,221 $2,749 $155,970 

December 31, 2022
Amortized CostUnrealized Holding Gains (Losses)Fair Value
Short-term marketable securities:
U.S. agency securities$79,347 $452 $79,799 
Corporate debt securities123,821 (220)123,601 
Total short-term marketable securities203,168 232 203,400 
Long-term marketable securities:
Corporate equity securities5,000 (2,924)2,076 
Total long-term marketable securities5,000 (2,924)2,076 
Total$208,168 $(2,692)$205,476 
Contractual maturities of the marketable securities at each balance sheet date are as follows (in thousands):
December 31,
20232022
Within one year$153,221 $203,168 
After one year through five years— — 
Total$153,221 $203,168 
v3.24.0.1
Business Combinations and Asset Acquisition
12 Months Ended
Dec. 31, 2023
Business Combination and Asset Acquisition [Abstract]  
Business Combinations and Asset Acquisition BUSINESS COMBINATIONS AND ASSET ACQUISITION
Business Combinations
HLA Data Systems
In January 2023, the Company acquired HLA Data Systems, a Texas-based company that provides software and interoperability solutions for the histocompatibility and immunogenetics community. The Company acquired HLA Data Systems with a combination of cash consideration paid upfront and contingent consideration with a fair value of $1.3 million.
The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.4 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the consolidated statement of operations.
Goodwill of $2.1 million arising from the acquisition primarily consists of synergies from integrating HLA Data Systems’ technology with the current testing and digital solutions offered by the Company. The acquisition of HLA Data Systems will provide a robust and comprehensive Laboratory Information Management System and support the laboratory workflows. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment.
The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
Estimated Fair Value
Estimated Useful Lives (Years)
Customer relationships$3,010 13
Developed technology770 11
Trademarks320 17
Total$4,100 
Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of HLA Data Systems’ products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset.
The acquired developed technology represents the fair value of HLA Data Systems’ proprietary software. The trademark acquired consists primarily of the HLA Data Systems brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 10% and 2% were used to estimate the fair value of the developed technology and the trademark, respectively.
A discount rate of 24% was utilized in estimating the fair value of these three intangible assets.
The pro forma impact of the HLA Data Systems acquisition is not material, and the results of operations of the acquisition have been included in the Company’s consolidated statements of operations from the respective acquisition date.
MediGO
In July 2023, the Company acquired MediGO, an organ transplant supply chain and logistics company. MediGO provides access to donated organs by digitally transforming donation and transplantation workflows to increase organ utilization. The Company acquired MediGO with a combination of cash consideration paid upfront and contingent consideration with a fair value of $0.3 million.
The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.3 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the consolidated statement of operations.
Goodwill of $0.6 million arising from the acquisition primarily consists of synergies from integrating MediGO’s technology with the current testing and digital solutions offered by the Company. The acquisition of MediGO will provide a comprehensive software platform that optimizes complex logistics from referral to recovery and during the critical movement of organs and teams and gives organ procurement organizations and transplant centers the ability to unify decentralized stakeholders, coordinate resources and make vital decisions with the goal of increasing organ utilization and improving equity and access to transplantation. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment.
The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
Estimated Fair Value
Estimated Useful Lives (Years)
Customer relationships$810 17
Developed technology850 12
Trademarks360 17
Total$2,020 
Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of MediGO’s products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset.
The acquired developed technology represents the fair value of MediGO’s proprietary software. The trademark acquired consists primarily of the MediGO brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 10% and 2% were used to estimate the fair value of the developed technology and the trademark, respectively.
A discount rate of 25% was utilized in estimating the fair value of these three intangible assets.
The pro forma impact of the MediGO acquisition is not material, and the results of operations of the acquisition have been included in the Company’s consolidated statements of operations from the respective acquisition date.
Combined Consideration Paid
The following table summarizes the consideration paid for HLA Data Systems and MediGO and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
Total
Consideration
Cash
$6,682 
Total consideration
$6,682 
Recognized amounts of identifiable assets acquired and liabilities assumed
Current assets$1,413 
Identifiable intangible assets6,120 
Current liabilities(1,060)
Other current liabilities(810)
Contingent considerations(1,620)
Other liabilities(7)
Total identifiable net assets acquired4,036 
Goodwill2,646 
Total consideration$6,682 
The preliminary allocation of the purchase price to assets acquired and liabilities assumed was based on the fair value of such assets and liabilities as of the acquisition date.
Asset Acquisition
Effective as of August 9, 2023, the Company purchased an asset from a private entity. The asset consists of a licensing agreement with a university institution. See also Note 9.
The purchased asset did not meet the definition of a business under ASC Topic 805, Business Combinations, and therefore the Company accounted for the transaction as an asset acquisition. In an asset acquisition, goodwill is not recognized, but rather, any excess consideration transferred over the fair value of the net assets acquired is allocated on a relative fair value basis to the identifiable assets acquired.
Acquisition costs relating to the asset acquired were $2.6 million, comprised of base consideration of $1.8 million, contingent consideration at fair value of $0.5 million and associated transaction costs of $0.3 million. There was only one asset acquired and the entire cost is assigned to the licensing agreement, which is recorded under Intangible assets, net, in the consolidated balance sheets and under the intangible assets with indefinite lives category.
v3.24.0.1
Goodwill and Intangible Assets
12 Months Ended
Dec. 31, 2023
Goodwill and Intangible Assets Disclosure [Abstract]  
Goodwill and Intangible Assets GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified intangible assets acquired.
Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or earlier upon the occurrence of certain events or substantive changes in circumstances. The Company identified an indicator of goodwill impairment during the quarter ended September 30, 2023 due to a sustained decrease in share price.
During the quarter ended September 30, 2023, the Company estimated the fair value of its reporting unit using a combination of the income and market approaches. In performing the goodwill impairment test, the Company used an exit multiple given the development phase of the Company and a discount rate of 16.4% in its estimation of fair value. The evaluation performed resulted in no impairment as of September 30, 2023.
On December 1, 2023, the Company performed a qualitative assessment of its reporting unit taking into consideration past, current and projected future earnings, recent trends and market conditions, and its market capitalization. Based on this analysis, the Company concluded that it was more likely than not that the fair value of the reporting unit exceeded its carrying amount. As such, it was not necessary to perform the quantitative goodwill impairment assessment at this time. As of December 31, 2023, no impairment of goodwill has been identified.
The following table presents details of the Company’s goodwill as of December 31, 2023 and 2022 (in thousands):
20232022
Balance as of January 1,$37,523 $36,983 
Goodwill acquired2,646 540 
Remeasurement adjustment
167 — 
Balance as of December 31,$40,336 $37,523 
Intangible Assets
The following table presents details of the Company’s intangible assets as of December 31, 2023 ($ in thousands):
December 31, 2023
Gross
Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net Carrying
Amount
Weighted
Average
Remaining
Useful Life
(In Years)
Intangible assets with finite lives:
Acquired and developed technology$37,367 $(18,340)$(2,269)$16,758 7.2
Customer relationships25,718 (9,094)(1,959)14,665 9.2
Commercialization rights11,579 (4,496)— 7,083 5.6
Trademarks and tradenames5,220 (1,713)(288)3,219 9.3
Total intangible assets with finite lives79,884 (33,643)(4,516)41,725 
Acquired in-process technology1,250 — — 1,250 
Favorable license agreement2,726 — — 2,726 
Total intangible assets with indefinite lives3,976 — — 3,976 
Total intangible assets$83,860 $(33,643)$(4,516)$45,701 
The following table presents details of the Company’s intangible assets as of December 31, 2022 ($ in thousands):
December 31, 2022
Gross
Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net Carrying
Amount
Weighted
Average
Remaining
Useful Life
(In Years)
Intangible assets with finite lives:
Acquired and developed technology$35,747 $(15,138)$(2,369)$18,240 7.5
Customer relationships21,898 (7,459)(2,104)12,335 9.0
Commercialization rights11,579 (3,233)— 8,346 6.6
Trademarks and tradenames4,540 (1,345)(315)2,880 8.5
Total intangible assets with finite lives73,764 (27,175)(4,788)41,801 
Acquired in-process technology1,250 — — 1,250 
Total intangible assets$75,014 $(27,175)$(4,788)$43,051 
Acquisition of intangible assets
In January and July 2023, the Company acquired the intangible assets of HLA Data Systems and MediGO, respectively. The intangible assets are included in Acquired and developed technology, Customer relationships and Trademarks and tradenames as of December 31, 2023.
Amortization of Intangible Assets
Intangible assets are carried at cost less accumulated amortization. Amortization expenses are recorded to cost of testing services, cost of product, cost of patient and digital solutions, and sales and marketing expenses in the consolidated statements of operations.
The following table summarizes the Company's amortization expense of intangible assets (in thousands):
Year Ended December 31,
202320222021
Cost of testing services$1,316 $1,316 $1,316 
Cost of product1,655 1,716 1,905 
Cost of patient and digital solutions1,039 945 684 
Sales and marketing2,457 2,252 1,891 
Total $6,467 $6,229 $5,796 
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of December 31, 2023 (in thousands):
Years Ending December 31,Cost of Testing Services
Cost of
Product
Cost of Patient and Digital Solutions
Sales and
Marketing
Total
2024$1,316 $1,715 $850 $2,557 $6,438 
20251,316 1,715 681 2,557 6,269 
20261,316 751 681 2,554 5,302 
20271,316 751 681 2,541 5,289 
20281,316 751 681 2,541 5,289 
Thereafter1,509 2,567 1,462 7,600 13,138 
Total future amortization expense$8,089 $8,250 $5,036 $20,350 $41,725 
v3.24.0.1
Balance Sheet Components
12 Months Ended
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Balance Sheet Components BALANCE SHEET COMPONENTS
Inventory
Inventory consisted of the following (in thousands):
December 31,
20232022
Finished goods$3,658 $2,962 
Work in progress5,191 4,306 
Raw materials10,622 11,964 
Total inventory$19,471 $19,232 
Property and Equipment, Net
Property and equipment consisted of the following (in thousands):
December 31,
20232022
Leasehold improvements$18,259 $17,389 
Machinery and equipment18,051 16,294 
Internally developed software15,116 10,893 
Construction in progress8,306 7,639 
Computer and office equipment5,609 5,570 
Furniture and fixtures2,168 2,168 
Property and equipment67,509 59,953 
Less: Accumulated depreciation and amortization(32,263)(24,424)
Property and equipment, net$35,246 $35,529 
Depreciation expense was $7.9 million, $5.2 million and $2.7 million for the years ended December 31, 2023, 2022 and 2021, respectively.
There were no assets purchased under finance leases during 2023. Accumulated depreciation was $0.6 million and $0.6 million at December 31, 2023 and 2022, respectively. Related amortization expense, included in depreciation and amortization expense, was $0.0 million, $0.1 million and $0.1 million for the three years ended December 31, 2023, 2022 and 2021, respectively.
Accrued and Other Liabilities
Accrued and other liabilities consisted of the following (in thousands):
December 31,
20232022
Clinical studies$15,744 $14,816 
Short-term lease liability5,943 5,591 
Professional fees5,911 6,115 
Contingent consideration5,469 1,025 
Deferred revenue4,748 5,342 
Laboratory processing fees and materials2,890 2,189 
Accrued royalty348 4,633 
Deferred payments for intangible assets920 2,062 
Accrued shipping expenses335 489 
License and other collaboration fees250 1,000 
Capital expenditures151 1,316 
Other accrued expenses2,788 4,553 
Total accrued and other liabilities$45,497 $49,131 
v3.24.0.1
Commitments and Contingencies
12 Months Ended
Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies COMMITMENTS AND CONTINGENCIES
Leases
The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease agreements in Brisbane, California; Columbus, Ohio; West Chester, Pennsylvania; Flowood, Mississippi; Gaithersburg, Maryland; Omaha, Nebraska; Fremantle, Australia; and Stockholm, Sweden.
The Company's facility leases expire at various dates through 2033. In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties.
As of December 31, 2023, the carrying value of the ROU asset was $29.9 million. The related current and non-current liabilities as of December 31, 2023 were $5.9 million and $28.3 million, respectively. The current and non-current lease liabilities are included in accrued and other current liabilities and operating lease liability, less current portion, respectively, in the consolidated balance sheets.
The following table summarizes the lease cost for the years ended December 31, (in thousands):
202320222021
Operating lease cost$7,936 $6,716 $5,134 
Finance lease cost— — 53 
Total lease cost$7,936 $6,716 $5,187 
Finance lease cost included interest from the lease liability and amortization of the ROU asset.
December 31,
20232022
Other information:
Weighted-average remaining lease term - Operating leases (in years)5.436.26
Weighted-average discount rate - Operating leases (%)7.1 %7.1 %
In February and June 2022, the Company entered into various lease agreements to lease office buildings in California, Nebraska, and Australia with lease terms ranging from 2 to 10.5 years. Certain leases have options to renew the lease terms ranging from 5 to 10 years.
In June 2022, the Company modified the termination date of the lease agreement for its headquarters in South San Francisco, California from December 31, 2022 to July 15, 2022. As a result, the Company remeasured its lease liability using the current incremental borrowing rate and made an adjustment by reducing the ROU asset and lease liability by $0.5 million.
Lease liabilities for the lease agreements made in February and June 2022 are recognized at the present value of the fixed lease payments using the current incremental borrowing rate at the lease commencement date. ROU assets are recognized based on the initial present value of the fixed lease payments.
The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in July 2022 (in thousands):
December 31,
20232022
ROU assets$12,073 $14,321 
Lease liabilities$13,221 $15,302 
The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in August 2022 (in thousands):
December 31,
20232022
ROU assets$5,347 $5,814 
Lease liabilities$5,627 $6,005 
Supplemental cash flow information related to leases for the years ended December 31, are as follows (in thousands):
202320222021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used for operating leases$5,454 $3,665 $2,580 
Operating cash flows used for finance leases— — 63 
Total$5,454 $3,665 $2,643 
Maturities of operating lease liabilities as of December 31, 2023, are as follows (in thousands):
Years ending December 31,Operating Leases
2024$7,993 
20257,875 
20267,124 
20277,274 
20286,599 
Thereafter4,115 
Total lease payments40,980 
Less imputed interest6,759 
Present value of future minimum lease payments34,221 
Less operating lease liability, current portion5,943 
Operating lease liability, long-term portion$28,278 
Royalty Commitments
The Board of Trustees of the Leland Stanford Junior University (“Stanford”)
In June 2014, the Company entered into a license agreement with Stanford (the “Stanford License”), which granted the Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone payments and royalties in the low single digits of net sales of products incorporating the licensed technology. In March 2023,
the Stanford License agreement was amended, which reduced the maximum royalty rate to a lower rate at which the Company may be liable to Stanford effective from April 2022 and also provided that the Company would seek a review from the U.S. Supreme Court (the “Review”). During the pendency of the Review, certain of the Company’s licensing payment and reporting obligations to Stanford with respect to licensed products sold in the U.S. were suspended. As a result, the Company reversed the excess liability in March 2023.
In May 2023, the Company submitted a petition of certiorari to the U.S. Supreme Court for consideration of the patent infringement suit and in October 2023, the U.S. Supreme Court declined to hear this patent infringement suit. As the Review is complete and the Company's petition for review was denied, the Stanford License automatically terminated, and in December 2023, the Company paid Stanford certain past royalties at a reduced rate that were previously suspended within 90 days of the termination. There was no outstanding obligation with Stanford as of December 31, 2023.
Illumina
On May 4, 2018, the Company entered into the License Agreement with Illumina (the “Illumina Agreement”). The Illumina Agreement requires the Company to pay royalties in the mid-single to low-double digits on sales of products covered by the Illumina Agreement.
Other Royalty Commitment
Effective as of August 2023, the Company entered into a license agreement with a university institution (the "University Agreement"). The University Agreement requires the Company to pay royalties in the low single digits on sales of products covered by the University Agreement.
Cibiltech Commitments
Pursuant to that certain license and commercialization agreement that the Company entered into with Cibiltech, effective April 30, 2019, the Company will share an agreed-upon percentage of revenue with Cibiltech, if and when revenues are generated from iBox.
In July 2023, the Company entered into a settlement agreement with Cibiltech (the “Settlement Agreement”), pursuant to which the Company agreed to pay a certain amount of its obligation owed to Cibiltech. A judicial court in Paris, France, granted the liquidation of Cibiltech, which filed for bankruptcy. In the Settlement Agreement, Cibiltech irrevocably waived and relinquished any and all claims, demands, grievances, proceeding, actions or other requests, whether judicial, administrative, arbitral or otherwise, against the Company. The outstanding obligation of the Company with Cibiltech was waived and relinquished, except for $0.4 million, which was paid in July 2023, and represented the amount that the Company agreed to per the Settlement Agreement. There was no outstanding obligation as of December 31, 2023.
Tax Commitments
As of December 31, 2023, the Company had gross unrecognized tax benefits of $6.2 million, which include penalties and interest of $0.2 million. Approximately $0.2 million has been recorded as a noncurrent liability. At this time, the Company is unable to make a reasonably reliable estimate of the timing of payments in individual years in connection with these tax liabilities.
Other Commitments
Pursuant to the Illumina Agreement, the Company has agreed to minimum purchase commitments of finished products and raw materials from Illumina.
Effective as of July 2023, the Company entered into a license and collaboration agreement with a private entity pursuant to which the Company was granted an irrevocable, non-transferable right to commercialize its proprietary software, iBox, for the predictive analysis of post-transplantation kidney allograft loss in the field of transplantation for a period of four years with exclusive rights in the United States. The Company will share an agreed-upon percentage of revenue with the private entity, if and when revenues are generated from iBox.
Litigation and Indemnification Obligations
In response to the Companys false advertising suit filed against Natera Inc. (“Natera”) on April 10, 2019, Natera filed a counterclaim against the Company on February 18, 2020, in the U.S. District Court for the District of Delaware (the “Court”) alleging the Company made false and misleading claims about the performance capabilities of AlloSure. The suit seeks injunctive relief and unspecified monetary relief. On September 30, 2020, Natera requested leave of Court to amend its counterclaims to include additional allegations regarding purportedly false claims the Company made with respect to AlloSure,
and the Court granted Natera’s request. The trial commenced on March 7, 2022 and concluded on March 14, 2022, with the jury finding that Natera violated the Lanham Act by falsely advertising the scientific performance of its Prospera transplant test and awarding the Company $44.9 million in damages, comprised of $21.2 million in compensatory damages and $23.7 million in punitive damages. In July 2023, the Court upheld and reaffirmed the March 2022 jury verdict but did not uphold the monetary damages awarded by the jury, which the Company intends to appeal. In August 2023, the Court issued an injunction prohibiting Natera from making the claims the jury previously found to be false advertising. The case is now on appeal.
On July 19, 2022, the U.S. Court of Appeals for the Federal Circuit affirmed the Court’s judgment dismissing the Company’s patent infringement suit against Natera. In May 2023, the Company submitted a petition of certiorari to the U.S. Supreme Court for consideration of the patent infringement suit and in October 2023, the U.S. Supreme Court declined to hear the suit.
In addition, Natera filed suit against the Company on January 13, 2020, in the Court alleging, among other things, that AlloSure infringes Natera’s U.S. Patent 10,526,658. This case was consolidated with the Company’s patent infringement suit on February 4, 2020. On March 25, 2020, Natera filed an amendment to the suit alleging, among other things, that AlloSure also infringes Natera’s U.S. Patent 10,597,724. The suit seeks a judgment that the Company has infringed Natera’s patents, an order preliminarily and permanently enjoining the Company from any further infringement of such patents and unspecified damages. On May 13, 2022, Natera filed two new complaints alleging that AlloSure infringes Natera’s U.S. Patents 10,655,180 and 11,111,544. These two cases were consolidated with the patent infringement case on June 15, 2022. On May 17, 2022, Natera agreed to dismiss the case alleging infringement of Natera’s U.S. Patent 10,526,658. On July 6, 2022, the Company moved to dismiss the rest of Natera’s claims. On September 6, 2022, the Company withdrew its motion to dismiss. On December 11, 2023, the Court dismissed the case alleging infringement of Natera's U.S. Patent 10,597,724. Natera has appealed that decision. See Note 17, Subsequent Events, for further information.
United States Department of Justice and United States Securities and Exchange Commission Investigations
As previously disclosed, in 2021, the Company received a civil investigative demand (“CID”) from the United States Department of Justice (“DOJ”) requesting that the Company produce certain documents in connection with a False Claims Act investigation being conducted by the DOJ regarding certain business practices related to the Company’s kidney testing and phlebotomy services, and a subpoena from the United States Securities and Exchange Commission (the “SEC”) in relation to an investigation by the SEC in respect of matters similar to those identified in the CID, as well as certain of the Company’s accounting and public reporting practices. By letter dated September 19, 2023, the Company was notified by the staff of the SEC that the SEC has concluded its investigation as to the Company and does not intend to recommend an enforcement action by the SEC against the Company. The notice was provided under the guidelines set out in the final paragraph of Securities Act Release No. 5310.
The Company may receive additional requests for information from the DOJ, the SEC, or other regulatory and governmental agencies regarding similar or related subject matters. The Company does not believe that the CID raises any issues regarding the safety or efficacy of any of the Company’s products or services and is cooperating fully with the DOJ investigation. Although the Company remains committed to compliance with all applicable laws and regulations, it cannot predict the outcome of the DOJ investigation or any other requests or investigations that may arise in the future regarding these or other subject matters.
From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the consolidated financial statements indicates that it is probable that a liability had been incurred at the date of the consolidated financial statements, and (ii) the range of loss can be reasonably estimated.
Olymbios Matter
On April 15, 2022, a complaint was filed by Michael Olymbios against the Company in the Superior Court of the State of California for the County of San Mateo (the “San Mateo County Court”). The complaint alleged that the Company failed to pay certain fees and costs required to continue an arbitration proceeding against Dr. Olymbios, and that the Company has defamed Dr. Olymbios. Dr. Olymbios also sought to void restrictive covenants previously agreed to by him in favor of the Company and to recover damages purportedly incurred by Dr. Olymbios. The Company filed a motion to compel arbitration and dismiss the case. On April 25, 2022, the San Mateo County Court granted the Company’s ex parte application to stay the case and advance the hearing date to June 10, 2022 for the motion to compel arbitration and dismiss. At the June 10, 2022 hearing, the San Mateo County Court found that the decision should be made by the arbitrator, and stayed the case. On July 19, 2022, Dr. Olymbios filed a motion to withdraw from arbitration before Judicial Arbitration and Mediation Services, Inc., which was denied on
August 18, 2022. Both the arbitration and the San Mateo County Court matter were settled in the fourth quarter of 2023 and have been resolved.
Securities Class Action
On May 23, 2022, Plumbers & Pipefitters Local Union #295 Pension Fund filed a federal securities class action in the U.S. District Court for the Northern District of California against the Company, Reginald Seeto, its former President, Chief Executive Officer and member of the Company’s Board of Directors, Ankur Dhingra, its former Chief Financial Officer, Marcel Konrad, its former interim Chief Financial Officer and former Senior Vice President of Finance & Accounting, and Peter Maag, its former President, former Chief Executive Officer, former Chairman of the Company’s Board of Directors and current member of the Company’s Board of Directors. The action alleges that the Company and the individual defendants made materially false and/or misleading statements and/or omissions and that such statements violated Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-5 promulgated thereunder. The action also alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks to recover damages caused by the alleged violations of federal securities laws, along with the plaintiffs’ costs incurred in the lawsuit, including their reasonable attorneys’ and experts’ witness fees and other costs.
On August 25, 2022, the court appointed an investor group led by the Oklahoma Police Pension and Retirement System as lead plaintiffs and appointed Saxena White P.A. and Robbins Geller Rudman & Dowd LLP as lead counsels. Plaintiffs filed an amended complaint on November 28, 2022. On January 27, 2023, defendants moved to dismiss all claims and to strike certain allegations in the amended complaint.
On May 24, 2023, the court granted the Company’s motion to strike and motion to dismiss, dismissing all claims against defendants with leave to amend. On June 28, 2023, plaintiffs filed a second amended complaint against the Company, Reginald Seeto, Ankur Dhingra, and Peter Maag. Under a briefing schedule ordered by the court on June 12, 2023, defendants’ motion to dismiss and motion to strike the second amended complaint was filed on July 26, 2023, plaintiffs’ opposition was filed on August 30, 2023, and defendants’ reply was filed on September 22, 2023. The court held oral argument on October 31, 2023. The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suit, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for this suit. See Note 17, Subsequent Events, for further information.
Derivative Actions
On September 21, 2022, Jeffrey Edelman brought a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Drs. Seeto and Maag and Mr. Dhingra, and other current and former members of the Company’s Board of Directors (the Edelman Derivative Action). The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, waste of corporate assets, unjust enrichment and violations of Sections 14(a) and 20(a) of the Exchange Act. The action alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks a declaration that the individual defendants breached their fiduciary duties to the Company, violated Sections 14(a) and 20(a) of the Exchange Act and were unjustly enriched, and also seeks to recover damages sustained by the Company as a result of the alleged violations, along with the plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’ and experts’ fees, costs and expenses.
On December 8, 2022, the court stayed the Edelman Derivative Action until 20 days after the earlier of the following events: (a) the securities class action is dismissed in its entirety with prejudice; (b) the motion to dismiss in the securities class action is denied; (c) a joint request by plaintiff and defendants to lift the stay; (d) notification that a related derivative action that has been filed is not stayed or is no longer stayed; or (e) notification that there has been a settlement reached in the securities class action or any related derivative action.
On February 7, 2023, Jaysen Stevenson brought a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Drs. Seeto and Maag and Mr. Dhingra and other current and former members of the Company’s Board of Directors (the “Stevenson Derivative Action”). The claims and allegations in the Stevenson Derivative Action are substantially similar to those in the Edelman Derivative Action. The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, waste of corporate assets, unjust enrichment and violations of Sections 14(a) and 20(a) of the Exchange Act. The suit seeks declaratory relief and to recover alleged damages sustained by the Company as a result of the alleged violations, along with the plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’ and experts’ fees, costs and expenses.
On March 9, 2023, the court consolidated the Edelman Derivative Action and the Stevenson Derivative Action and stayed both actions pursuant to the terms of the stay order in the Edelman Derivative Action. The consolidated derivative action remains stayed. The parties in the Stevenson Derivative Action filed a joint status statement with the court on September 6, 2023. See Note 17, Subsequent Events, for further information.
The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there are no guarantees that the Company will prevail.
Insurance Matter
In December 2022, the Company filed a lawsuit against its directors and officers liability insurance carriers in San Mateo County Superior Court. The Company seeks a declaration that costs and fees incurred by the Company in responding to governmental investigatory requests are covered under its policies. The Company also asserts breach of contract against its primary insurer Great American Insurance Company for denying the claim. The policies provide up to $15 million in coverage limits. The Company intends to vigorously pursue its claims, and believes it has good and substantial support for its claims, but there is no guarantee that the Company will prevail in these claims. The parties are presently briefing the Company's entitlement to coverage under the policies.
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Stockholders' Equity
12 Months Ended
Dec. 31, 2023
Stockholders' Equity Note [Abstract]  
Stockholders' Equity STOCKHOLDERS’ EQUITY
Stock Repurchase Program
On December 3, 2022, the Company's Board of Directors approved a Stock Repurchase Program (the "Repurchase Program"), whereby the Company may purchase up to $50 million in shares of its common stock over a period of up to two years, commencing on December 8, 2022. The Repurchase Program may be carried out at the discretion of a committee of the Board of Directors through open market purchases, one or more Rule 10b5-1 trading plans, block trades and in privately negotiated transactions. For the years ended December 31, 2023 and 2022, the Company purchased an aggregate of 2,942,997 and 50,051 shares of its common stock, respectively, under the Repurchase Program for an aggregate purchase price of $27.5 million and $0.6 million, respectively. As of December 31, 2023, $21.9 million remained available for future repurchases under the Repurchase Program.
These shares were retired upon repurchase. The Company's policy related to repurchase of its common stock is to charge the excess of cost over par value to accumulated deficit.
January 2021 Underwritten Public Offering of Common Stock
On January 25, 2021, the Company sold 1,923,077 shares of its common stock through an underwritten public offering at a public offering price of $91.00 per share. The net proceeds to the Company from the offering were approximately $164.0 million, after deducting underwriting discounts and commissions and offering expenses.
On February 11, 2021, the Company sold 288,461 shares of its common stock pursuant to the full exercise of the overallotment option granted to the underwriters in connection with the January 2021 offering. The net proceeds to the Company from the full exercise of the underwriters' overallotment option were approximately $24.7 million.
The Company did not issue preferred stock during the years ended December 31, 2023, 2022 and 2021.
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401(K) Plan
12 Months Ended
Dec. 31, 2023
Retirement Benefits [Abstract]  
401(K) Plan 401(K) PLAN
The Company sponsors a 401(k) defined contribution plan covering all U.S. employees under the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”). Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. The Company incurred expenses related to contributions to the plan of $1.7 million, $1.8 million and $1.4 million for the years ended December 31, 2023, 2022 and 2021, respectively.
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Warrants
12 Months Ended
Dec. 31, 2023
Warrants and Rights Note Disclosure [Abstract]  
Warrants WARRANTS
The Company issues common stock warrants in connection with debt or equity financings to lenders, placement agents and investors. Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity or liability classification in accordance with U.S. GAAP. Warrants that are classified as liabilities usually have various features that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet the exception criteria are classified as equity. Warrants liabilities are remeasured at fair value at each period end with changes in fair value recorded in the consolidated statements of operations until expired or exercised. Warrants that are classified as equity are valued at their relative fair value on the date of issuance, recorded in additional paid in capital and not remeasured.
During the year ended December 31, 2023, warrants to purchase approximately 3,000 shares of common stock were exercised for cash proceeds of $4,000. During the year ended December 31, 2022, no warrants to purchase shares of common stock were exercised.
As of December 31, 2023, no warrants to purchase common stock were outstanding.
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Stock Incentive Plans
12 Months Ended
Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]  
Stock Incentive Plans STOCK INCENTIVE PLANS
2014 Equity Incentive Plan
The Company grants stock based awards under 2014 Equity Incentive Plan (the “2014 Plan”) that allows for issuance of stock options, restricted stock units (“RSUs”) and other stock awards to the Company’s employees, directors, and consultants. Stock options granted under the 2014 Plan may be exercised when vested and generally expire ten years from the date of the grant or three months from the date of termination of employment. Vesting periods vary based on awards granted, however, certain stock-based awards may vest immediately or may accelerate based on performance-driven measures. Stock option awards generally vest over four years with first year annual cliff vesting. The RSUs generally vest annually over four years in equal increments. There were 670,455 shares of common stock reserved for future issuance under the 2014 Plan as of December 31, 2023.
2016 Inducement Plan
On April 21, 2016, the Company adopted the 2016 Inducement Equity Incentive Plan (the “2016 Plan”), pursuant to which the Company may grant stock awards of up to a total of 155,500 shares of common stock to new employees of the Company. The 2016 Plan was adopted to accommodate a reserve of additional shares of common stock for issuance to new employees hired by the Company from Allenex AB. The terms in the 2016 Plan are substantially similar to the 2014 Plan. There were 62,752 shares of common stock reserved for future issuance under the 2016 Plan as of December 31, 2023.
The 2016 Plan allows RSUs to be granted in addition to stock options. The RSUs vest annually over four years in equal increments. The Company began granting RSUs pursuant to the 2016 Plan starting June 2016.
2019 Inducement Equity Incentive Plan
The Company grants stock based awards under 2019 Inducement Equity Incentive Plan (the “2019 Plan”) that allows for issuance of stock options, RSUs and other stock awards to new employees of the Company. Stock options granted under the 2019 Plan may be exercised when vested and generally expire ten years from the date of the grant or three months from the date of termination of employment. Vesting periods vary based on awards granted, however, certain stock-based awards may vest immediately or may accelerate based on performance-driven measures. Stock option awards generally vest over four years with first year annual cliff vesting. The RSUs generally vest annually over four years in equal increments. The terms in the 2019 Plan are substantially similar to the 2014 Plan. There were 135,904 shares of common stock reserved for future issuance under the 2019 Plan as of December 31, 2023.
Stock Options and RSUs
The following table summarizes option and RSUs activity under the Company’s 2014 Plan, 2016 Plan and 2019 Plan, and related information:
Shares
Available
for Grant
Stock
Options
Outstanding
Weighted-
Average
Exercise
Price
Number of
RSU Shares
Weighted-
Average
Grant Date
Fair Value
Balance—December 31, 20221,490,462 2,921,925 $28.13 3,094,396 $37.39 
Additional options authorized2,141,330 — — — — 
Common stock awards for services(21,965)— — — — 
RSUs granted(4,028,424)— — 4,028,424 10.52 
RSUs vested— — — (989,314)36.43 
Options granted(680,788)680,788 12.60 — — 
Options exercised— (27,903)4.29 — — 
Repurchases of common stock under employee incentive plans322,163 — — — — 
RSUs forfeited1,126,731 — — (1,126,731)22.92 
Options forfeited265,395 (265,395)26.90 — — 
Options expired254,207 (254,207)27.13 — — 
Balance—December 31, 2023869,111 3,055,208 $25.21 5,006,775 $19.02 
The total intrinsic value of options exercised was $0.1 million, $1.6 million and $42.9 million for the years ended December 31, 2023, 2022 and 2021, respectively.
The total fair value of RSUs vested during 2023 was $9.5 million. As of December 31, 2023, the total intrinsic value of outstanding RSUs was approximately $61.6 million and there were $55.8 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 2.23 years.
The Company granted performance restricted stock units ("PSUs"), included in RSUs, under the 2014 Plan. The PSUs granted to employees consist of financial and operational metrics to be met over a performance period of 2 years. The number of shares outstanding was 449,983 and 160,538 as of December 31, 2023 and December 31, 2022, respectively. The weighted-average period was 1.01 years and 1.16 years for the years ended December 31, 2023 and 2022, respectively.
Options outstanding that have vested and are expected to vest at December 31, 2023 are as follows:
Number of
Shares Issued (In thousands)
Weighted Average Exercise
Price
Weighted
Average
Remaining
Contractual Life
(Years)
Aggregate
Intrinsic Value
(In thousands)
Vested1,786 $26.21 6.27$1,751 
Expected to Vest1,191 23.56 8.59530 
Total2,977 $2,281 
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock at December 31, 2023 for stock options that were in-the-money.
The weighted-average grant-date fair value of options to purchase common stock granted for the years ended December 31, 2023, 2022 and 2021 using the Black-Scholes Model was $8.63, $19.51 and $52.65, respectively.
The total fair value of options that vested during 2023 was $18.4 million. As of December 31, 2023, there were approximately $17.5 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 2.26 years.
2014 Employee Stock Purchase Plan
The Company has an Employee Stock Purchase Plan (the “ESPP”), under which employees can purchase shares of its common stock based on a percentage of their compensation, but not greater than 15% of their earnings; provided, however, an eligible employee’s right to purchase shares of the Company’s common stock may not accrue at a rate which exceeds $25,000 of the fair market value of such shares for each calendar year in which such rights are outstanding. The ESPP has consecutive offering periods of approximately six months in length. The purchase price per share must be equal to the lower of 85% of the fair value of the common stock on the first day of the offering period or on the exercise date.
During the offering period in 2023 that ended on June 30, 2023, 143,817 shares were purchased for aggregate proceeds of $1.0 million from the issuance of shares, which occurred on July 6, 2023. During the offering period in 2023 that ended on December 31, 2023, 73,759 shares were purchased for aggregate proceeds of $0.5 million from the issuance of shares, which occurred on January 2, 2024. The Company issued 190,842 shares and 93,422 shares of common stock during the years ended December 31, 2023 and December 31, 2022, respectively, pursuant to the ESPP. The Company received proceeds of $1.5 million and $3.0 million from the purchases of shares during the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company had 583,906 shares available for issuance under the ESPP.
Board of Directors Stock Awards Granted for Services
For the years ended December 31, 2023, 2022 and 2021, the Company paid a portion of its directors’ compensation through the award of fully vested common shares. The stock awards are classified as equity, and compensation expense was recognized upon the issuance of the shares at the grant date price per share, which is the fair value. As of December 31, 2023, there were a total of 310,609 shares issued to the Company’s directors, for a total fair value of $2.5 million. Stock-based compensation expense associated with the awards was $0.2 million, $0.4 million and $0.3 million for the years ended December 31, 2023, 2022 and 2021, respectively, which was included in general and administrative expense on the consolidated statements of operations.
Valuation Assumptions
The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions:
Year Ended December 31,
202320222021
Employee stock options
Expected term (in years)5.615.965.94
Expected volatility77.86 %77.62 %77.70 %
Risk-free interest rate3.67 %2.74 %0.80 %
Expected dividend yield— %— %— %
Employee stock purchase plan
Expected term (in years)0.50.50.5
Expected volatility
75.91% – 93.38%
67.79% – 77.88%
53.10% – 67.79%
Risk-free interest rate
5.26% – 5.47%
2.51% – 4.76%
0.09% – 0.19%
Expected dividend yield— %— %— %
Risk-free Interest Rate: The Company based the risk-free interest rate over the expected term of the award based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of grant.
VolatilityThe Company used an average historical stock price volatility of its own stock.
Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical exercise patterns and termination behavior.
Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future.
Stock-Based Compensation Expense
The following table summarizes stock-based compensation expense relating to employee and nonemployee stock-based awards for the years ended December 31, 2023, 2022 and 2021, included on the consolidated statements of operations as follows (in thousands):
Year Ended December 31,
202320222021
Cost of testing services$1,854 $1,529 $2,358 
Cost of product1,165 1,120 579 
Cost of patient and digital solutions1,377 1,331 728 
Research and development6,556 7,391 7,126 
Sales and marketing12,470 14,403 10,887 
General and administrative25,664 20,779 14,403 
Total$49,086 $46,553 $36,081 
No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable income (after net operating loss) and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets. In addition, stock-based compensation costs were only capitalized under Internal Revenue Code Section 174, capitalized research and development costs for the periods presented.
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Income Taxes
12 Months Ended
Dec. 31, 2023
Income Tax Disclosure [Abstract]  
Income Taxes INCOME TAXES
Loss before income taxes for the years ended December 31, 2023, 2022 and 2021 is summarized as follows (in thousands):
As of December 31,
202320222021
United States$(188,421)$(73,089)$(27,921)
Foreign(1,722)(3,145)(4,167)
Total loss before income taxes$(190,143)$(76,234)$(32,088)
The components of the provision for (benefit from) income taxes are summarized as follows (in thousands):
As of December 31,
202320222021
Current
Federal$(117)$145 $89 
State186 328 
Foreign— 184 (139)
Total current income tax expense (benefit)69 657 (48)
Deferred
Federal184 (130)(409)
State(112)75 (127)
Foreign— (223)(842)
Total deferred income tax expense (benefit)
72 (278)(1,378)
Income tax expense (benefit)$141 $379 $(1,426)
The Company's actual provision for tax differed from the amounts computed by applying the U.S. federal income tax rates of 21% in each of the years ended 2023, 2022 and 2021, to loss before income taxes as a result of the following:
Year Ended December 31,
202320222021
Federal tax statutory rate21.0 %21.0 %21.0 %
Stock-based compensation(3.8)%(2.8)%38.8 %
Change in valuation allowance(18.1)%(16.9)%86.4 %
Foreign rate differential0.2 %(0.2)%0.7 %
Non-deductible executive compensation(0.4)%(2.1)%(23.4)%
Research credits0.4 %1.8 %6.9 %
Changes in net operating loss carryforwards, including expirations0.8 %(0.5)%(125.1)%
Other(0.2)%(0.8)%(0.9)%
Effective income tax rate(0.1)%(0.5)%4.4 %
Deferred income tax assets and liabilities consist of the following (in thousands):
As of December 31, 2023
20232022
Deferred tax assets:
Net operating loss carryforwards$30,260 $26,658 
Tax credit carryforwards10,317 9,138 
Accruals26,256 2,971 
Lease liability7,947 9,250 
Section 174 capitalized costs31,724 20,602 
Stock-based compensation12,799 7,798 
Other1,351 959 
Gross deferred tax assets120,654 77,376 
Valuation allowance(102,865)(59,499)
Total deferred tax assets17,789 17,877 
Deferred tax liabilities:
Purchased intangibles(6,112)(6,615)
Operating leases right-of-use assets(6,914)(8,189)
Property and equipment(4,443)(2,548)
Other(456)(497)
Total deferred tax liabilities(17,925)(17,849)
Net deferred tax (liabilities) assets
$(136)$28 
The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and negative, including (1) cumulative results of operations in recent years, (2) sources of recent losses, (3) estimates of future taxable income and (4) the length of net operating loss carryforward periods. The Company believes that based on the history of its U.S. losses and other factors, the weight of available evidence indicates that it is more likely than not that it will not be able to realize its U.S. net deferred tax assets. The Company has also placed a valuation allowance on the net deferred tax assets of its Swedish operations. The valuation allowance increased by $43.4 million and $13.9 million during the years ended December 31, 2023 and 2022, respectively.
As of December 31, 2023, the Company had domestic federal net operating loss carryforwards of $109.1 million, domestic state net operating loss carryforwards of $77.6 million, and foreign net operating loss carryforwards of $12.0 million that can reduce future taxable income. The domestic federal and state net operating loss carryforwards will begin to expire in 2024 and 2030, respectively. The foreign net operating loss carryforwards can be carried forward indefinitely.
As of December 31, 2023, the Company had credit carryforwards of approximately $11.5 million and $11.1 million available to reduce future taxable income, if any, for domestic federal and California state income tax purposes, respectively. The domestic federal credit carryforwards will begin to expire in 2023. California credits have no expiration date.
The Company has recorded a valuation allowance against its deferred tax assets at December 31, 2023 and 2022 because the Company's management believes that it is more likely than not that these assets will not be fully realized. The increase in the valuation allowance is approximately $43.4 million in the year ended December 31, 2023.
A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands):
Year Ended December 31,
202320222021
Balance at the beginning of the year$5,436 $4,156 $4,416 
Additions based on tax positions related to the current year839 1,255 805 
Additions based on tax positions related to prior years— 25 130 
Decreases based on tax positions related to prior years(91)— (1,195)
Balance at the end of the year$6,184 $5,436 $4,156 
None of the $6.2 million of net unrecognized tax benefit as of December 31, 2023, if recognized, would impact the Company's effective tax rate. During the year ended December 31, 2023, given the Company's valuation allowance, the uncertain tax benefits would not have impacted the effective tax rate.
The Company recognizes interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of December 31, 2023 and December 31, 2022, the Company had in each year $0.2 million of cumulative interest and penalties related to unrecognized tax benefits. The Company does not anticipate a significant change in the unrecognized tax benefits over the next twelve months.
The Company files U.S., state and foreign income tax returns in jurisdictions with varying statutes of limitations. Due to net operating loss and credit carryovers, the domestic federal and state income tax returns are subject to tax authority examination from inception. In the foreign jurisdictions where the Company files income tax returns, the statutes of limitations with respect to these jurisdictions vary from jurisdiction to jurisdiction and range from 3 to 6 years.
v3.24.0.1
Segment Reporting
12 Months Ended
Dec. 31, 2023
Segment Reporting [Abstract]  
Segment Reporting SEGMENT REPORTING
Operating segments are defined as components of an enterprise for which separate financial information is available that is evaluated regularly by the Company’s CODM, or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its Office of the Chief Executive Officer as the CODM. In determining its reportable segments, the Company considered the markets and types of customers served and the products or services provided in those markets. The Company operates in a single reportable segment.
Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
Year Ended December 31,
202320222021
Testing services revenue
United States$209,158 $262,959 $258,412 
Rest of World527 789 873 
$209,685 $263,748 $259,285 
Product revenue
United States$19,753 $16,409 $13,512 
Europe9,901 9,081 9,740 
Rest of World3,863 3,761 3,580 
$33,517 $29,251 $26,832 
Patient and digital solutions revenue
United States$36,719 $28,175 $10,085 
Europe266 468 82 
Rest of World137 151 113 
$37,122 $28,794 $10,280 
Total United States$265,630 $307,543 $282,009 
Total Europe$10,167 $9,549 $9,822 
Total Rest of World$4,527 $4,701 $4,566 
Total$280,324 $321,793 $296,397 
The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):
December 31, 2023December 31, 2022
Long-lived assets:
United States$34,714 $35,020 
Europe476 405 
Rest of World56 104 
Total$35,246 $35,529 
v3.24.0.1
Restructuring
12 Months Ended
Dec. 31, 2023
Restructuring and Related Activities [Abstract]  
Restructuring RESTRUCTURING
In January 2023, the Company announced a restructuring plan that is intended to optimize costs and simplify its organizational and corporate structure. The restructuring plan includes the discontinuation of operations at one of its two locations in Fremantle, Australia. The Company expects to complete the closure of the affected location in June 2024. The Company incurred immaterial restructuring charges for the year ended December 31, 2023.
In May and December 2023, the Company announced a reduction of its workforce to simplify and streamline its organization and strengthen the overall effectiveness of its operations. The restructuring charges are primarily related to employee severance pay and related costs. As a result of this plan, the Company incurred $2.2 million in restructuring charges for the year ended December 31, 2023.
v3.24.0.1
Subsequent Events
12 Months Ended
Dec. 31, 2023
Subsequent Events [Abstract]  
Subsequent Events SUBSEQUENT EVENTS
Litigation
As discussed in Note 9, Commitment and Contingencies, Natera filed claims against the Company alleging that AlloSure infringes Natera’s U.S. Patents 10,655,180 and 11,111,544. On January 26, 2024, following a five-day trial, a jury concluded that the Company did not infringe Natera's U.S. Patent 10,655,180 but did infringe Natera's U.S. Patent 11,111,544. The jury awarded Natera approximately $96.3 million in damages based on sales of AlloSure and AlloSeq between September 2021 and August 2023. Natera's U.S. Patent 11,111,544 expires in September 2026. The Company anticipates continued litigation as to whether its current AlloSure process infringes the patent. Natera may also move for injunctive relief. The Company intends to seek judicial review of the verdict and contest any potential claims of ongoing infringement and any motion for injunctive relief. The Company intends to defend these matters vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there is no guarantee that the Company will prevail. The Company recorded the damages of $96.3 million as other liabilities on the consolidated balance sheets as of December 31, 2023 and as litigation expense under the operating expense on the consolidated statements of operations for the year ended December 31, 2023.
Derivative Action
On February 8, 2024, Christian Jacobsen filed a stockholder derivative action complaint in the U.S. District Court for the Northern District of California against the Company as nominal defendant and Dr. Seeto, Mr. Dhingra, Dr. Maag, and other current and former members of the Company's Board of Directors (the “Jacobsen Derivative Action”). The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company, violated Section 14(a) of the Exchange Act, are liable for contribution under Sections 10(b) and 21(D) of the Exchange Act, engaged in unjust enrichment, waste of corporate assets, aiding and abetting, insider trading, and misappropriation of information, and/or are liable for indemnification. The suit seeks declaratory relief, disgorgement, and to recover alleged damages sustained by the Company as a result of the alleged violations, along with plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’, accountants’, and experts’ fees, costs, and expenses. The Jacobsen Derivative Action was designated related to the consolidated derivative action.
As discussed in Note 9, Commitment and Contingencies, the court consolidated the Edelman Derivative Action and the Stevenson Derivative Action. On February 13, 2024, the parties in the consolidated derivative action filed a joint status statement and administrative motion with the court.
Securities Class Action
As discussed in Note 9, Commitment and Contingencies, on May 3, 2022, Plumbers & Pipefitters Local Union #295 Pension Fund filed a federal securities class action against the Company and Reginald Seeto, Ankur Dhingra, and Peter Maag. The parties filed a joint status statement with the court on February 15, 2024.
The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there are no guarantees that the Company will prevail.
v3.24.0.1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Pay vs Performance Disclosure      
Net Income (Loss) $ (190,284) $ (76,613) $ (30,662)
v3.24.0.1
Insider Trading Arrangements
3 Months Ended
Dec. 31, 2023
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.0.1
Summary of Significant Accounting Policies (Policies)
12 Months Ended
Dec. 31, 2023
Accounting Policies [Abstract]  
Liquidity and Capital Resources
Liquidity and Capital Resources
The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $678.3 million at December 31, 2023. As of December 31, 2023, the Company had cash and cash equivalents and marketable securities of $235.4 million and no debt outstanding.
Basis of Presentation
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its subsidiaries. Intercompany transactions have been eliminated.
Use of Estimates
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; standalone fair value of patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of assets and liabilities acquired in a business combination or an asset acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination or an asset acquisition; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties
Concentrations of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to credit risk consist of cash, cash equivalents, marketable securities and accounts receivable. The Company’s policy is to invest its cash and cash equivalents in money market funds, obligations of U.S. government agencies and government-sponsored entities, commercial paper, corporate debt securities and various bank deposit accounts. The counterparties to the agreements relating to the Company’s investments consist of financial institutions of high credit standing. The Company is exposed to credit risk in the event of default by the financial institutions to the extent of amounts recorded on the balance sheets that may be in excess of insured limits.
The Company is also subject to credit risk from its accounts receivable, which are derived from revenue earned from AlloSure Kidney, AlloSure Heart and AlloMap Heart tests provided for patients located in the U.S. and Canada, and billed to various third-party payers, from sales of products to distributors, strategic partners and transplant laboratories in Europe, Asia, the Middle East, Africa, the U.S., Latin America and other geographic regions, from sales of patient and digital solutions software. The Company has not experienced any significant credit losses and does not require collateral on receivables. For the years ended December 31, 2023, 2022 and 2021, approximately 40%, 53% and 59%, respectively, of total revenue was billed to Medicare. No other payers represented more than 10% of total revenue for the years ended December 31, 2023, 2022 and 2021.
As of December 31, 2023 and 2022, approximately 36% and 27%, respectively, of accounts receivable was due from Medicare. No other payer represented more than 10% of accounts receivable at either December 31, 2023 or 2022.
Cash and Cash Equivalents
Cash and Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase. Cash equivalents consist primarily of amounts invested in money market funds.
Restricted Cash
Restricted Cash
As a condition of the lease agreements for certain facilities the Company must maintain letters of credit and certain minimum collateral requirements. The cash used to support these arrangements of $0.6 million is classified as long-term restricted cash on the accompanying consolidated balance sheets.
Marketable Securities
Marketable Securities
The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of December 31, 2023, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase, which were classified as current assets on the consolidated balance sheet.
The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net, on the consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification.
The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of December 31, 2023, the Company’s long-term marketable securities consisted of corporate equity securities. These long-term marketable securities are classified as other assets on the consolidated balance sheet.
The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other income (expense), net, on the consolidated statements of operations.
Inventory
Inventory
Inventory is finished goods, work in progress, and raw materials and consists of reagent plates, laboratory supplies, reagents and finished goods kits. Inventories are used in connection with tests performed, kits produced and prescription drugs, and may also be used for research and product development efforts. Laboratory supplies subsequently designated for research and product development use are expensed. Obsolete or damaged inventories are written off. Certain inventories are stated at the lower of purchased cost, determined on an average cost basis, or net realizable value. Inventories are stated at the lower of actual purchased cost, determined on an average cost basis, on a first-in, first-out basis, or at net realizable value.
Property and Equipment, net
Property and Equipment, net
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. The estimated useful life is generally three to five years for computer, office and laboratory equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remaining lease term.
The Company capitalizes certain costs incurred for software developed or obtained for internal use, including hosting arrangements. These costs include software licenses and consulting services, as well as employee payroll and payroll-related costs. Capitalized internal-use software costs are usually amortized over a period of three to seven years.
Business Combinations
Business Combinations
The Company determines and allocates the purchase price of an acquired business to the assets acquired and liabilities assumed based on their estimated fair values as of the business combination date, including separately identifiable intangible assets, which are separable from goodwill. The Company bases the estimated fair value of identifiable intangible assets acquired in a business combination on independent valuations that use information and assumptions provided by management, which consider management’s best estimates of inputs and assumptions that a market participant would use. The Company allocates any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities assumed to goodwill. The use of alternative valuation assumptions, including estimated revenue projections, growth rates, royalty rates, cash flows, discount rates, estimated useful lives and probabilities surrounding the achievement of contingent milestones could result in different purchase price allocations and amortization expense in current and future periods.
In those circumstances where an acquisition involves a contingent consideration arrangement that meets the definition of a liability under Accounting Standard Codification (“ASC”), Topic 480, Distinguishing Liabilities from Equity, the Company recognizes a liability equal to the fair value of the contingent payments that the Company expects to make as of the acquisition date. The Company remeasures this liability each reporting period and records changes in the fair value as a component of operating expenses. In circumstances where the contingent consideration is classified as equity, the Company recognizes it at fair value at the acquisition date. Contingent consideration classified as equity is not subsequently remeasured.
Transaction costs associated with acquisitions are expensed as incurred in general and administrative expenses. Results of operations and cash flows of acquired companies are included in the Company’s operating results from the date of acquisition.
Acquired Intangible Assets
Acquired Intangible Assets
Amortizable intangible assets include customer relationships, developed technology, commercialization rights, trademarks and in-process technology assets acquired as part of a business combination or asset acquisition. Intangible assets subject to amortization are amortized over their estimated useful lives. Acquired in-process technology assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time.
Impairment of Goodwill, Intangible Assets and Long-lived Assets
Impairment of Goodwill, Intangible Assets and Long-lived Assets
Goodwill
Goodwill recorded in a business combination is not subject to amortization. Instead, it is tested for impairment on an annual basis and whenever events or changes in circumstances indicate its carrying amount may not be recoverable.
The Company’s annual impairment test date is December 1st. A qualitative assessment is initially made to determine whether it is necessary to perform a quantitative assessment. A qualitative assessment includes, among others, consideration of: (i) past, current and projected future earnings; (ii) recent trends and market conditions; and (iii) valuation metrics involving similar companies that are publicly-traded and acquisitions of similar companies, if available. If this qualitative assessment indicates that it is more likely than not that an impairment exists, or if the Company decides to bypass this option, it proceeds to the quantitative assessment. The quantitative assessment consists of a comparison between the estimated fair value of the Company’s reporting unit and its respective carrying amount including goodwill. Where the carrying value of the reporting unit exceeds its estimated fair value, the Company will record an impairment charge based on that difference. The impairment charge will be limited to the amount of goodwill allocated to that reporting unit.
When necessary, to determine the reporting unit’s fair value under the quantitative approach, the Company uses a combination of income and market approaches, such as estimated discounted future cash flows of that reporting unit, multiples of earnings or revenues, and analysis of recent sales or offerings of comparable entities. The Company also considers its market capitalization on the date of the analysis to ensure the reasonableness of the reporting unit’s fair value.
In connection with the Company’s annual goodwill assessment on December 1, 2023, the Company performed a qualitative assessment taking into consideration past, current and projected future earnings, recent trends and market conditions; and the Company's market capitalization. Based on this analysis, the Company concluded that it was more likely than not that the fair value of the reporting unit exceeded its carrying amount. As such, it was not necessary to perform the quantitative goodwill impairment assessment at that time. As of December 31, 2023, no impairment of goodwill has been identified.
Intangible assets not subject to amortization
The Company evaluates the carrying value of intangible assets not subject to amortization, related to acquired in-process technology assets and a favorable license agreement, which are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. Accordingly, amortization of the acquired in-process technology assets and the favorable license agreement will not occur until the products reach commercialization.
During the period the assets are considered indefinite-lived, they are tested for impairment on an annual basis, as well as between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate that the fair value of the acquired in-process technology assets and the favorable license agreement are less than their carrying amounts. An impairment loss would be recorded when the fair value of an acquired in-process technology asset and the favorable license agreement are less than the carrying value. If and when development is complete, which generally occurs when the products are made commercially available, the associated acquired in-process technology asset and the favorable license agreement will be deemed finite-lived and will then be amortized based on the estimated useful life.
As of December 31, 2023, no impairment of acquired in-process technology assets and the favorable license agreement has been identified.
Intangible assets and long-lived assets subject to amortization
The Company evaluates its finite-lived intangible assets and its long-lived assets for indicators of possible impairment when events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company then compares the carrying amounts of the assets with the future net undiscounted cash flows expected to be generated by such asset. If an impairment exists, the Company measures the impairment based on the excess carrying value of the asset over the asset’s fair value determined using discounted estimates of future cash flows. The Company has not identified any material impairment losses to date.
Fair Value of Financial Instruments
Fair Value of Financial Instruments
Fair value is defined as the price that would be received from selling an asset or the price paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which the Company would transact, and it takes into consideration the assumptions that market participants would use when pricing the asset or liability. The Company’s assessment of the significance of a particular input to the fair value measurement of an asset or liability requires management to make judgments and to consider specific characteristics of that asset or liability.
The carrying amounts of certain financial instruments of the Company, including cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their short maturities. The carrying amount of the contingent consideration liability also represents its fair value.
Leases
Leases
The Company adopted ASC Topic 842, Leases (“ASC 842”) and determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. The Company also has lease arrangements with lease and non-lease components. The Company elected the practical expedient not to separate non-lease components from lease components for the Company's facility leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for leases with an initial term of 12 months or less.
The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment.
As of December 31, 2023, the Company’s leases had remaining terms of 0.42 years to 9.09 years, some of which include options to extend the lease term.
Revenue
Revenue
The Company recognizes revenue from testing services, product sales, and patient and digital solutions revenue in the amount that reflects the consideration that it expects to be entitled in exchange for goods or services as it transfers control to its
customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
Testing Services Revenue
AlloSure Kidney, AlloMap Heart, AlloSure Heart and AlloSure Lung patient tests are ordered by healthcare providers. The Company receives a test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to be its customer and the test requisition form to be the contract. Testing services are performed in the Company’s laboratory. Testing services represent one performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a point in time.
The healthcare providers that order the tests and on whose behalf the Company provides testing services are generally not responsible for the payment of these services. The first and second revenue recognition criteria are satisfied when the Company receives a test requisition form with payer information from the healthcare provider. Generally, the Company bills third-party payers upon delivery of an AlloSure Kidney, AlloMap Heart, AlloSure Heart or AlloSure Lung test result to the healthcare provider. Amounts received may vary amongst payers based on coverage practices and policies of the payer. The Company has used the portfolio approach under ASC Topic 606, Revenue from Contracts with Customers, to identify financial classes of payers. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where applicable. The Company estimates revenue for non-contracted payers and self-payers using transaction prices determined for each financial class of payers using history of reimbursements. This includes analysis of an average reimbursement per test and a percentage of tests reimbursed. This estimate requires significant judgment.
The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates.
In March and May 2023, MolDX issued new billing articles related to the LCD entitled Molecular Testing for Solid Organ Allograft Rejection. The billing article issued in May 2023 (the “Revised Billing Article”) and together with the billing article issued in March 2023 (the “Billing Articles”) impacted Medicare coverage for AlloSure Kidney, AlloSure Heart, AlloMap Heart and AlloSure Lung, and required certain companies, including the Company, to implement new processes to address the requirements related to Medicare claim submissions. Noridian adopted the Revised Billing Article on August 17, 2023, with a retroactive effective date of March 31, 2023.
Although the Company believes the Billing Articles are inconsistent with the LCDs, Noridian’s and MolDX’s responses to public comments explaining the intended scope of various LCDs, and medical necessity, the Company determined to pause its Medicare reimbursement submissions for AlloSure Kidney commencing on March 7, 2023 to allow the Company further time to evaluate the implications of the Billing Article and update the Company's billing processes for AlloSure Kidney tests by educating clinicians and working with centers to update the Company's test order forms to capture the new information required under the Billing Article. Accordingly, the Company did not submit claims for approximately 3,200 AlloSure Kidney tests for Medicare reimbursement for the period from March 7, 2023 through March 31, 2023 and did not recognize revenue on these claims in the first quarter of 2023 aggregating to approximately $8.9 million (the “Impacted March Tests”).
On May 18, 2023, the Company submitted a letter to Noridian explaining, among other things, (i) its belief that the Billing Articles impose new restrictions on Medicare coverage for the CareDx tests from those contained in the existing LCDs, (ii) that the Company planned to submit claims for reimbursement for the Impacted March Tests for which it had not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing Articles, and (iii) that AlloSure Kidney orders with a date of service on or after March 31, 2023 for other indications outside the parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article. Following the submission of this letter to Noridian on May 18, 2023, the Company submitted claims for reimbursement for the Impacted March Tests for which the Company subsequently received payment from Noridian and recognized revenue totaling approximately $7.8 million in the second quarter of 2023.
The Company continued the Medicare reimbursement submissions for AlloMap Heart or AlloSure Heart following the issuance of the Billing Articles. In addition, the Company informed Noridian on May 18, 2023 that until Noridian adopts the Revised Billing Article, the Company would continue to submit AlloSure Heart tests for reimbursement only when used in conjunction with AlloMap Heart according to requirements of the Billing Article currently effective at Noridian. The Company also informed Noridian on May 18, 2023 that (i) until June 30, 2023, the Company plans to submit claims for reimbursement for AlloMap Heart and AlloSure Heart tests for which the Company has not obtained additional information from the ordering physicians to be able to specifically determine whether these tests meet the new coverage restrictions contained in the Billing
Articles, and (ii) AlloSure Heart and AlloMap Heart orders placed on or after June 30, 2023 for other indications outside the surveillance and for-cause parameters of the Revised Billing Article, or where the reason for testing is not specified by the ordering physician, will either not be billed pending the receipt of additional information regarding whether the orders meet the coverage restrictions contained in the Revised Billing Article or be submitted with a test description that is intended to identify those tests as falling outside the parameters of the Revised Billing Article.
On August 28, 2023, the Company submitted a subsequent letter to Noridian regarding its AlloSure Heart and AlloMap Heart testing submissions, explaining, among other things, that (i) prior to August 17, 2023, the Company submitted claims as outlined in its prior communications, including submitting AlloSure Heart and AlloMap Heart claims that were in compliance with the billing article in effect for Noridian (but that were not necessarily in compliance with the Revised Billing Article that had not yet been adopted by Noridian); (ii) for claims with dates of service of August 17, 2023 or later, the Company is submitting AlloSure Heart and AlloMap Heart testing claims in compliance with the Revised Billing Article, including submitting AlloSure Heart claims when not used in conjunction with AlloMap Heart, and submitting HeartCare (AlloSure Heart and AlloMap Heart used together in a single patient encounter) claims for surveillance testing in lieu of a biopsy from 55 days to 370 days post-transplant; and (iii) for AlloSure Heart and AlloMap Heart tests performed on or after August 17, 2023 that are outside the parameters of the Revised Billing Article, certain billing codes will be used to enable any additional review deemed appropriate by Noridian and potential appeal by the Company of the denied claims.
On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 14, 2023, MolDX released a draft billing article (DA58019) to accompany the proposed draft LCD, which generally reflected the changes in coverage included in the Revised Billing Article. The comment period end date for this proposed LCD was September 23, 2023. The Company presented at public meetings regarding the proposed draft LCD held on September 18, 2023 and September 20, 2023, with MolDX and Noridian respectively. The Company also submitted written comments on the proposed draft LCD.
Product Revenue
Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied. The Company generally has a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and the risk of loss is passed to the customer upon either shipping or delivery, as per the terms of the agreement.
Patient and Digital Solutions Revenue
Patient and digital solutions revenue is mainly derived from a combination of software as a service (“SaaS”) and perpetual software license agreements entered into with various transplant centers, which are the Company’s customers for this class of revenue. The main performance obligations in connection with the Company’s SaaS and perpetual software license agreements are the following: (i) implementation services and delivery of the perpetual software license, which are considered a single performance obligation, and (ii) post contract support. The Company allocates the transaction price to each performance obligation based on relative stand-alone selling prices of each distinct performance obligation. Digital revenue in connection with perpetual software license agreements is recognized over time based on the Company’s satisfaction of each distinct performance obligation in each agreement.
Perpetual software license agreements typically require advance payments from customers upon the achievement of certain milestones. The Company records deferred revenue in relation to these agreements when cash payments are received or invoices are issued in advance of the Company’s performance, and generally recognizes revenue over the contractual term, as performance obligations are fulfilled.
In addition, the Company derives patient and digital solutions revenue from software subscriptions and medication sales. The Company generally bills software subscription fees in advance. Revenue from software subscriptions is deferred and recognized ratably over the subscription term. The medication sales revenue is recognized based on the negotiated contract price with the governmental, commercial and non-commercial payers with any applicable patient co-pay. The Company recognizes revenue from medication sales when prescriptions are delivered.
Cost of Testing Services
Cost of testing services reflects the aggregate costs incurred in delivering the Company’s testing services. The components of cost of testing services are materials and service costs, direct labor costs, stock-based compensation, equipment and infrastructure expenses associated with testing samples, shipping, logistics and specimen processing charges to collect and transport samples, and allocated overhead including rent, information technology, equipment depreciation, utilities and royalties. Royalties for licensed technology, calculated as a percentage of testing services revenues, are recorded as license fees in cost of testing services at the time the testing services revenues are recognized.
Cost of Product
Cost of product reflects the aggregate costs incurred in delivering the Company’s products to customers. The components of cost of product are materials costs, manufacturing and kit assembly costs, direct labor costs, equipment and infrastructure expenses associated with preparing kitted products for shipment, shipping, and allocated overhead including rent, information technology, equipment depreciation and utilities. Cost of product also includes amortization of acquired developed technology and adjustments to inventory values, including write-downs of impaired, slow moving or obsolete inventory.
Cost of Patient and Digital Solutions
Cost of patient and digital solutions primarily consists of personnel-related costs associated with developing, installing and maintaining software, depreciation of servers and equipment, amortization of acquired intangible assets, support of the functionality of the software's platforms, including stock-based compensation expenses, cost of prescription drugs and allocated costs of facilities and information technology.
Research and Development Expenses
Research and Development Expenses
Research and development expenses, including clinical operations, represent costs incurred to develop diagnostic products and services, high quality evidence to support use of the Company’s tests, as well as continued efforts related to improving the Company’s existing products and patient and digital solutions service lines. These expenses include payroll and related expenses, consulting expenses, laboratory supplies, clinical studies and certain allocated expenses as well as amounts incurred under certain collaborative agreements. Research and development costs are expensed as incurred. The Company records accruals for estimated study costs comprised of work performed by contract research organizations under contract terms.
Stock-based Compensation
Stock-based Compensation
The Company uses the Black-Scholes Model, which requires the use of estimates such as stock price volatility and expected option lives, to value employee stock options. The Company estimates the expected option lives using historical data, estimates volatility using its own historical stock prices, estimates risk-free rates using the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected option lives, and estimates dividend yield using the Company’s expectations and historical data. The fair value of each restricted stock unit is calculated based upon the closing price of the Company’s common stock on the date of the grant.
The Company uses the straight-line attribution method for recognizing compensation expense. Compensation expense is recognized on awards ultimately expected to vest and reduced for forfeitures that are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based on the Company’s historical experience.
Compensation expense for stock options issued to nonemployees is calculated using the Black-Scholes Model and is recorded over the service performance period using the straight-line attribution method. Options subject to vesting are required to be periodically remeasured over their service performance period, which is generally the same as the vesting period.
Income Taxes
Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. The Company’s assessment of an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit may change as new information becomes available.
Foreign Currency Translation
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiaries is the local currency for each entity, including the Swedish Krona, Australian dollar and the Euro. The revenue and expenses of such subsidiaries have been translated into U.S. dollars at average exchange rates prevailing during the period. Assets and liabilities have been translated at the rates of exchange on the
balance sheet date. The resulting cumulative translation adjustments are reported in other comprehensive loss. Foreign currency translation gains and losses on revenue and expenses are recognized in the consolidated statements of operations.
Comprehensive Loss
Comprehensive Loss
Comprehensive loss consists of net loss and other losses affecting stockholders’ equity that, under U.S. GAAP, are excluded from net income or loss. For the Company, such items consist of foreign currency losses on the translation of foreign assets and liabilities.
Recent Accounting Pronouncements
Recent Accounting Pronouncements
There were no recently adopted accounting standards which would have a material effect on the Company’s consolidated financial statements and accompanying disclosures, and no recently issued accounting standards that are expected to have a material impact on the Company’s consolidated financial statements and accompanying disclosures.
Effective in Future Periods
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosure of significant segment expenses. All current annual disclosures about a reportable segment’s profit or loss and assets will also be required in interim periods. The new guidance also requires disclosure of the title and position of the Chief Operating Decision Maker (“CODM”) and explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. The amendments set forth in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption of the amendments is permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statements. This ASU will be effective for the Company’s annual disclosures in fiscal year 2024 and interim-period disclosures in fiscal year 2025. As the amendments only relate to disclosures, there will be no impact on the Company’s financial position or results of operations.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 340): Improvements to Income Tax Disclosures, which requires annual disclosures in the rate reconciliation table to be presented using both percentages and reporting currency amounts, and this table must include disclosure of specific categories. Additional information will also be required for reconciling items that meet a quantitative threshold. The new guidance also requires enhanced disclosures of income taxes paid, including the amount of income taxes paid disaggregated by federal, state and foreign taxes and the amount of income taxes paid disaggregated by individual jurisdictions that exceed a quantitative threshold. The amendments should be applied on a prospective basis, but retrospective application is permitted. The amendments set forth in this ASU are effective for annual periods beginning after December 15, 2024 for public entities. This guidance will be effective for the Company’s annual disclosures in fiscal year 2025. As the amendments only relate to disclosures, there will be no impact on the Company’s financial position or results of operations.
v3.24.0.1
Net Loss Per Share (Tables)
12 Months Ended
Dec. 31, 2023
Earnings Per Share [Abstract]  
Summary of Computation of Basic and Diluted Net Loss Per Share
The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data):
 Year Ended December 31,
 202320222021
Numerator:   
Net loss used to compute basic net loss per share
$(190,284)$(76,613)$(30,662)
Net loss used to compute diluted net loss per share
$(190,284)$(76,613)$(30,662)
Denominator:
Weighted-average shares used to compute basic net loss per share
53,764,705 53,321,625 52,241,076 
Weighted-average shares used to compute diluted net loss per share
53,764,705 53,321,625 52,241,076 
Net loss per share:
Basic$(3.54)$(1.44)$(0.59)
Diluted$(3.54)$(1.44)$(0.59)
Summary of Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share
The following potentially dilutive securities have been excluded from diluted net loss per share because their effect would be antidilutive:
Year Ended December 31,
202320222021
Shares of common stock subject to outstanding options
3,055,208 2,921,925 1,863,633 
Shares of common stock subject to outstanding common stock warrants
— 3,132 3,132 
Restricted stock units5,001,370 3,092,467 2,047,657 
Total common stock equivalents8,056,578 6,017,524 3,914,422 
v3.24.0.1
Fair Value Measurements (Tables)
12 Months Ended
Dec. 31, 2023
Fair Value Disclosures [Abstract]  
Summary of Fair Value of Financial Assets and Liabilities Measured on Recurring Basis
The following table sets forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of December 31, 2023 and 2022 (in thousands):
December 31, 2023
Fair Value Measured Using
(Level 1)(Level 2)(Level 3)Total Balance
Assets
Cash equivalents:
Money market funds$60,525 $— $— $60,525 
Total$60,525 $— $— $60,525 
Liabilities
Short-term liabilities:
Contingent consideration$— $— $5,469 $5,469 
Long-term liabilities:
Contingent consideration— — 2,461 2,461 
Total$— $— $7,930 $7,930 
December 31, 2022
Fair Value Measured Using
(Level 1)(Level 2)(Level 3)Total Balance
Assets
Cash equivalents:
Money market funds$66,594 $— $— $66,594 
Long-term marketable securities:
Corporate equity securities2,076 — — 2,076 
Total$68,670 $— $— $68,670 
Liabilities
Short-term liabilities:
Contingent consideration$— $— $1,025 $1,025 
Long-term liabilities:
Contingent consideration— — 2,418 2,418 
Common stock warrant liability— — 32 32 
Total $— $— $3,475 $3,475 
Summary of Issuances, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments
The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):
(Level 3)
Common Stock Warrant Liability and Contingent Consideration
Balance at December 31, 2021
$5,480 
Change in estimated fair value of common stock warrant liability(107)
Additions to contingent consideration727 
Payment related to contingent consideration(2,625)
Balance at December 31, 2022
3,475 
Exercise of warrants(22)
Change in estimated fair value of common stock warrant liability(10)
Change in estimated fair value of contingent consideration on business combination
2,677 
Change in estimated fair value of contingent consideration on asset acquisition
166 
Additions to contingent consideration2,269 
Payment related to contingent consideration(625)
Balance at December 31, 2023
$7,930 
v3.24.0.1
Cash and Marketable Securities (Tables)
12 Months Ended
Dec. 31, 2023
Cash and Cash Equivalents [Abstract]  
Summary of Cash and Cash Equivalents
A reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets to the amount reported within the consolidated statements of cash flows is shown in the table below (in thousands):
December 31, 2023December 31, 2022December 31, 2021
Cash and cash equivalents$82,197 $89,921 $348,485 
Restricted cash586 522 211 
Total cash, cash equivalents, and restricted cash at the end of the period$82,783 $90,443 $348,696 
Summary of Marketable Securities
The amortized cost, gross unrealized holding losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the table below (in thousands):
December 31, 2023
Amortized Cost
Unrealized Holding Gains
Fair Value
Short-term marketable securities:
U.S. agency securities$80,468 $2,038 $82,506 
Corporate debt securities72,753 711 73,464 
Total short-term marketable securities153,221 2,749 155,970 
Total $153,221 $2,749 $155,970 

December 31, 2022
Amortized CostUnrealized Holding Gains (Losses)Fair Value
Short-term marketable securities:
U.S. agency securities$79,347 $452 $79,799 
Corporate debt securities123,821 (220)123,601 
Total short-term marketable securities203,168 232 203,400 
Long-term marketable securities:
Corporate equity securities5,000 (2,924)2,076 
Total long-term marketable securities5,000 (2,924)2,076 
Total$208,168 $(2,692)$205,476 
Contractual maturities of the marketable securities at each balance sheet date are as follows (in thousands):
December 31,
20232022
Within one year$153,221 $203,168 
After one year through five years— — 
Total$153,221 $203,168 
v3.24.0.1
Business Combinations and Asset Acquisition (Tables)
12 Months Ended
Dec. 31, 2023
Business Combination and Asset Acquisition [Abstract]  
Summary of Identified Intangible Assets Acquired at Acquisition Date
The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
Estimated Fair Value
Estimated Useful Lives (Years)
Customer relationships$3,010 13
Developed technology770 11
Trademarks320 17
Total$4,100 
The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
Estimated Fair Value
Estimated Useful Lives (Years)
Customer relationships$810 17
Developed technology850 12
Trademarks360 17
Total$2,020 
Summary of Fair Values of Assets Acquired and Liabilities Assumed as of Acquisition Date
The following table summarizes the consideration paid for HLA Data Systems and MediGO and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
Total
Consideration
Cash
$6,682 
Total consideration
$6,682 
Recognized amounts of identifiable assets acquired and liabilities assumed
Current assets$1,413 
Identifiable intangible assets6,120 
Current liabilities(1,060)
Other current liabilities(810)
Contingent considerations(1,620)
Other liabilities(7)
Total identifiable net assets acquired4,036 
Goodwill2,646 
Total consideration$6,682 
v3.24.0.1
Goodwill and Intangible Assets (Tables)
12 Months Ended
Dec. 31, 2023
Goodwill and Intangible Assets Disclosure [Abstract]  
Summary of Goodwill
The following table presents details of the Company’s goodwill as of December 31, 2023 and 2022 (in thousands):
20232022
Balance as of January 1,$37,523 $36,983 
Goodwill acquired2,646 540 
Remeasurement adjustment
167 — 
Balance as of December 31,$40,336 $37,523 
Summary of Intangibles
The following table presents details of the Company’s intangible assets as of December 31, 2023 ($ in thousands):
December 31, 2023
Gross
Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net Carrying
Amount
Weighted
Average
Remaining
Useful Life
(In Years)
Intangible assets with finite lives:
Acquired and developed technology$37,367 $(18,340)$(2,269)$16,758 7.2
Customer relationships25,718 (9,094)(1,959)14,665 9.2
Commercialization rights11,579 (4,496)— 7,083 5.6
Trademarks and tradenames5,220 (1,713)(288)3,219 9.3
Total intangible assets with finite lives79,884 (33,643)(4,516)41,725 
Acquired in-process technology1,250 — — 1,250 
Favorable license agreement2,726 — — 2,726 
Total intangible assets with indefinite lives3,976 — — 3,976 
Total intangible assets$83,860 $(33,643)$(4,516)$45,701 
The following table presents details of the Company’s intangible assets as of December 31, 2022 ($ in thousands):
December 31, 2022
Gross
Carrying
Amount
Accumulated
Amortization
Foreign
Currency
Translation
Net Carrying
Amount
Weighted
Average
Remaining
Useful Life
(In Years)
Intangible assets with finite lives:
Acquired and developed technology$35,747 $(15,138)$(2,369)$18,240 7.5
Customer relationships21,898 (7,459)(2,104)12,335 9.0
Commercialization rights11,579 (3,233)— 8,346 6.6
Trademarks and tradenames4,540 (1,345)(315)2,880 8.5
Total intangible assets with finite lives73,764 (27,175)(4,788)41,801 
Acquired in-process technology1,250 — — 1,250 
Total intangible assets$75,014 $(27,175)$(4,788)$43,051 
Summary of Finite-Lived Intangible Assets Amortization Expense
The following table summarizes the Company's amortization expense of intangible assets (in thousands):
Year Ended December 31,
202320222021
Cost of testing services$1,316 $1,316 $1,316 
Cost of product1,655 1,716 1,905 
Cost of patient and digital solutions1,039 945 684 
Sales and marketing2,457 2,252 1,891 
Total $6,467 $6,229 $5,796 
Summary of Estimated Future Amortization Expense of Intangible Assets
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of December 31, 2023 (in thousands):
Years Ending December 31,Cost of Testing Services
Cost of
Product
Cost of Patient and Digital Solutions
Sales and
Marketing
Total
2024$1,316 $1,715 $850 $2,557 $6,438 
20251,316 1,715 681 2,557 6,269 
20261,316 751 681 2,554 5,302 
20271,316 751 681 2,541 5,289 
20281,316 751 681 2,541 5,289 
Thereafter1,509 2,567 1,462 7,600 13,138 
Total future amortization expense$8,089 $8,250 $5,036 $20,350 $41,725 
v3.24.0.1
Balance Sheet Components (Tables)
12 Months Ended
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Summary of Inventory
Inventory consisted of the following (in thousands):
December 31,
20232022
Finished goods$3,658 $2,962 
Work in progress5,191 4,306 
Raw materials10,622 11,964 
Total inventory$19,471 $19,232 
Summary of Components of Property and Equipment
Property and equipment consisted of the following (in thousands):
December 31,
20232022
Leasehold improvements$18,259 $17,389 
Machinery and equipment18,051 16,294 
Internally developed software15,116 10,893 
Construction in progress8,306 7,639 
Computer and office equipment5,609 5,570 
Furniture and fixtures2,168 2,168 
Property and equipment67,509 59,953 
Less: Accumulated depreciation and amortization(32,263)(24,424)
Property and equipment, net$35,246 $35,529 
Summary of Components of Accrued and Other Liabilities
Accrued and other liabilities consisted of the following (in thousands):
December 31,
20232022
Clinical studies$15,744 $14,816 
Short-term lease liability5,943 5,591 
Professional fees5,911 6,115 
Contingent consideration5,469 1,025 
Deferred revenue4,748 5,342 
Laboratory processing fees and materials2,890 2,189 
Accrued royalty348 4,633 
Deferred payments for intangible assets920 2,062 
Accrued shipping expenses335 489 
License and other collaboration fees250 1,000 
Capital expenditures151 1,316 
Other accrued expenses2,788 4,553 
Total accrued and other liabilities$45,497 $49,131 
v3.24.0.1
Commitments and Contingencies (Tables)
12 Months Ended
Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]  
Summary of Lease Cost
The following table summarizes the lease cost for the years ended December 31, (in thousands):
202320222021
Operating lease cost$7,936 $6,716 $5,134 
Finance lease cost— — 53 
Total lease cost$7,936 $6,716 $5,187 
Finance lease cost included interest from the lease liability and amortization of the ROU asset.
December 31,
20232022
Other information:
Weighted-average remaining lease term - Operating leases (in years)5.436.26
Weighted-average discount rate - Operating leases (%)7.1 %7.1 %
Supplemental cash flow information related to leases for the years ended December 31, are as follows (in thousands):
202320222021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used for operating leases$5,454 $3,665 $2,580 
Operating cash flows used for finance leases— — 63 
Total$5,454 $3,665 $2,643 
Summary ROU Assets and Lease Liabilities for Lease Agreements
The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in July 2022 (in thousands):
December 31,
20232022
ROU assets$12,073 $14,321 
Lease liabilities$13,221 $15,302 
The following table summarizes the ROU assets and lease liabilities for certain lease agreements which commenced in August 2022 (in thousands):
December 31,
20232022
ROU assets$5,347 $5,814 
Lease liabilities$5,627 $6,005 
Summary of Maturities of Operating Lease Liabilities
Maturities of operating lease liabilities as of December 31, 2023, are as follows (in thousands):
Years ending December 31,Operating Leases
2024$7,993 
20257,875 
20267,124 
20277,274 
20286,599 
Thereafter4,115 
Total lease payments40,980 
Less imputed interest6,759 
Present value of future minimum lease payments34,221 
Less operating lease liability, current portion5,943 
Operating lease liability, long-term portion$28,278 
v3.24.0.1
Stock Incentive Plans (Tables)
12 Months Ended
Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]  
Summary of Options, RSUs Activity under 2014 Equity Incentive Plan and 2016 Inducement Plan and Related Information
The following table summarizes option and RSUs activity under the Company’s 2014 Plan, 2016 Plan and 2019 Plan, and related information:
Shares
Available
for Grant
Stock
Options
Outstanding
Weighted-
Average
Exercise
Price
Number of
RSU Shares
Weighted-
Average
Grant Date
Fair Value
Balance—December 31, 20221,490,462 2,921,925 $28.13 3,094,396 $37.39 
Additional options authorized2,141,330 — — — — 
Common stock awards for services(21,965)— — — — 
RSUs granted(4,028,424)— — 4,028,424 10.52 
RSUs vested— — — (989,314)36.43 
Options granted(680,788)680,788 12.60 — — 
Options exercised— (27,903)4.29 — — 
Repurchases of common stock under employee incentive plans322,163 — — — — 
RSUs forfeited1,126,731 — — (1,126,731)22.92 
Options forfeited265,395 (265,395)26.90 — — 
Options expired254,207 (254,207)27.13 — — 
Balance—December 31, 2023869,111 3,055,208 $25.21 5,006,775 $19.02 
Summary of Options Outstanding and Exercisable Vested or Expected to Vest
Options outstanding that have vested and are expected to vest at December 31, 2023 are as follows:
Number of
Shares Issued (In thousands)
Weighted Average Exercise
Price
Weighted
Average
Remaining
Contractual Life
(Years)
Aggregate
Intrinsic Value
(In thousands)
Vested1,786 $26.21 6.27$1,751 
Expected to Vest1,191 23.56 8.59530 
Total2,977 $2,281 
Summary of Weighted-Average Assumptions Used to Estimate Fair Value of Share-Based Awards
The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions:
Year Ended December 31,
202320222021
Employee stock options
Expected term (in years)5.615.965.94
Expected volatility77.86 %77.62 %77.70 %
Risk-free interest rate3.67 %2.74 %0.80 %
Expected dividend yield— %— %— %
Employee stock purchase plan
Expected term (in years)0.50.50.5
Expected volatility
75.91% – 93.38%
67.79% – 77.88%
53.10% – 67.79%
Risk-free interest rate
5.26% – 5.47%
2.51% – 4.76%
0.09% – 0.19%
Expected dividend yield— %— %— %
Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs
The following table summarizes stock-based compensation expense relating to employee and nonemployee stock-based awards for the years ended December 31, 2023, 2022 and 2021, included on the consolidated statements of operations as follows (in thousands):
Year Ended December 31,
202320222021
Cost of testing services$1,854 $1,529 $2,358 
Cost of product1,165 1,120 579 
Cost of patient and digital solutions1,377 1,331 728 
Research and development6,556 7,391 7,126 
Sales and marketing12,470 14,403 10,887 
General and administrative25,664 20,779 14,403 
Total$49,086 $46,553 $36,081 
v3.24.0.1
Income Taxes (Tables)
12 Months Ended
Dec. 31, 2023
Income Tax Disclosure [Abstract]  
Summary of Loss Before Income Taxes
Loss before income taxes for the years ended December 31, 2023, 2022 and 2021 is summarized as follows (in thousands):
As of December 31,
202320222021
United States$(188,421)$(73,089)$(27,921)
Foreign(1,722)(3,145)(4,167)
Total loss before income taxes$(190,143)$(76,234)$(32,088)
Summary of Components of Provision for (Benefit from) Income Taxes
The components of the provision for (benefit from) income taxes are summarized as follows (in thousands):
As of December 31,
202320222021
Current
Federal$(117)$145 $89 
State186 328 
Foreign— 184 (139)
Total current income tax expense (benefit)69 657 (48)
Deferred
Federal184 (130)(409)
State(112)75 (127)
Foreign— (223)(842)
Total deferred income tax expense (benefit)
72 (278)(1,378)
Income tax expense (benefit)$141 $379 $(1,426)
Summary of Provision for Tax Differed from Amounts Computed by Applying the U.S. Federal Income Tax Rate to Loss Before Income
The Company's actual provision for tax differed from the amounts computed by applying the U.S. federal income tax rates of 21% in each of the years ended 2023, 2022 and 2021, to loss before income taxes as a result of the following:
Year Ended December 31,
202320222021
Federal tax statutory rate21.0 %21.0 %21.0 %
Stock-based compensation(3.8)%(2.8)%38.8 %
Change in valuation allowance(18.1)%(16.9)%86.4 %
Foreign rate differential0.2 %(0.2)%0.7 %
Non-deductible executive compensation(0.4)%(2.1)%(23.4)%
Research credits0.4 %1.8 %6.9 %
Changes in net operating loss carryforwards, including expirations0.8 %(0.5)%(125.1)%
Other(0.2)%(0.8)%(0.9)%
Effective income tax rate(0.1)%(0.5)%4.4 %
Summary of Deferred Income Tax Assets and Liabilities
Deferred income tax assets and liabilities consist of the following (in thousands):
As of December 31, 2023
20232022
Deferred tax assets:
Net operating loss carryforwards$30,260 $26,658 
Tax credit carryforwards10,317 9,138 
Accruals26,256 2,971 
Lease liability7,947 9,250 
Section 174 capitalized costs31,724 20,602 
Stock-based compensation12,799 7,798 
Other1,351 959 
Gross deferred tax assets120,654 77,376 
Valuation allowance(102,865)(59,499)
Total deferred tax assets17,789 17,877 
Deferred tax liabilities:
Purchased intangibles(6,112)(6,615)
Operating leases right-of-use assets(6,914)(8,189)
Property and equipment(4,443)(2,548)
Other(456)(497)
Total deferred tax liabilities(17,925)(17,849)
Net deferred tax (liabilities) assets
$(136)$28 
Summary of Reconciliation of Unrecognized Tax Benefits
A reconciliation of the Company’s unrecognized tax benefits is as follows (in thousands):
Year Ended December 31,
202320222021
Balance at the beginning of the year$5,436 $4,156 $4,416 
Additions based on tax positions related to the current year839 1,255 805 
Additions based on tax positions related to prior years— 25 130 
Decreases based on tax positions related to prior years(91)— (1,195)
Balance at the end of the year$6,184 $5,436 $4,156 
v3.24.0.1
Segment Reporting (Tables)
12 Months Ended
Dec. 31, 2023
Segment Reporting [Abstract]  
Summary of Reportable Revenues by Geographic Regions
Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
Year Ended December 31,
202320222021
Testing services revenue
United States$209,158 $262,959 $258,412 
Rest of World527 789 873 
$209,685 $263,748 $259,285 
Product revenue
United States$19,753 $16,409 $13,512 
Europe9,901 9,081 9,740 
Rest of World3,863 3,761 3,580 
$33,517 $29,251 $26,832 
Patient and digital solutions revenue
United States$36,719 $28,175 $10,085 
Europe266 468 82 
Rest of World137 151 113 
$37,122 $28,794 $10,280 
Total United States$265,630 $307,543 $282,009 
Total Europe$10,167 $9,549 $9,822 
Total Rest of World$4,527 $4,701 $4,566 
Total$280,324 $321,793 $296,397 
Summary of Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions
The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):
December 31, 2023December 31, 2022
Long-lived assets:
United States$34,714 $35,020 
Europe476 405 
Rest of World56 104 
Total$35,246 $35,529 
v3.24.0.1
Organization and Description of Business (Details)
12 Months Ended 23 Months Ended
May 09, 2023
USD ($)
Apr. 01, 2023
USD ($)
Dec. 08, 2022
Dec. 03, 2022
USD ($)
Dec. 31, 2023
USD ($)
solution
shares
Dec. 31, 2022
USD ($)
shares
Mar. 31, 2023
USD ($)
May 10, 2023
shares
Jan. 31, 2018
patient
Schedule of Capitalization, Equity [Line Items]                  
Number of renal transplant patients (more than) | patient                 1,900
Accumulated deficit         $ 678,269,000 $ 460,444,000      
Cash, cash equivalents, and short-term investments         $ 235,400,000        
Shares reserved for future issuance of common stock (in shares) | shares               250,000,000  
Stock repurchase program, authorized amount       $ 50,000,000          
Stock repurchase program, period in force (in years)     2 years 2 years          
Number of common stock purchased (in shares) | shares         2,942,997 50,051      
Stock repurchased value         $ 27,500,000 $ 600,000      
Stock repurchase program, remaining authorized repurchase amount         $ 21,900,000        
XynManagement, Inc.                  
Schedule of Capitalization, Equity [Line Items]                  
Number of unique solutions | solution         2        
Miromatrix, Inc.                  
Schedule of Capitalization, Equity [Line Items]                  
Payments to acquire minority interest             $ 5,100,000    
AlloSure Kidney                  
Schedule of Capitalization, Equity [Line Items]                  
Reimbursement rate         $ 2,841        
AlloMap Heart                  
Schedule of Capitalization, Equity [Line Items]                  
Reimbursement rate         3,240        
AlloSure Heart                  
Schedule of Capitalization, Equity [Line Items]                  
Reimbursement rate         $ 2,753        
AlloSure lung Testing Services                  
Schedule of Capitalization, Equity [Line Items]                  
Reimbursement rate $ 2,753                
HeartCare                  
Schedule of Capitalization, Equity [Line Items]                  
Reimbursement rate   $ 5,993              
v3.24.0.1
Summary of Significant Accounting Policies - Additional Information (Details)
3 Months Ended 12 Months Ended
Sep. 30, 2023
USD ($)
Jun. 30, 2023
USD ($)
Dec. 31, 2023
USD ($)
Dec. 31, 2022
USD ($)
Dec. 31, 2021
USD ($)
Mar. 31, 2023
USD ($)
claim
Summary Of Significant Accounting Policies [Line Items]            
Restricted cash     $ 586,000 $ 522,000    
Goodwill impairment $ 0   0      
Impairment of intangible assets     0      
Total revenue     $ 280,324,000 $ 321,793,000 $ 296,397,000  
Furniture and fixtures            
Summary Of Significant Accounting Policies [Line Items]            
Estimated useful lives of assets (in years)     7 years      
Minimum            
Summary Of Significant Accounting Policies [Line Items]            
Remaining operating and finance lease term (in years)     5 months 1 day      
Minimum | Machinery, Computer and Office Equipment            
Summary Of Significant Accounting Policies [Line Items]            
Estimated useful lives of assets (in years)     3 years      
Minimum | Internally developed software            
Summary Of Significant Accounting Policies [Line Items]            
Estimated useful lives of assets (in years)     3 years      
Maximum            
Summary Of Significant Accounting Policies [Line Items]            
Remaining operating and finance lease term (in years)     9 years 1 month 2 days      
Maximum | Machinery, Computer and Office Equipment            
Summary Of Significant Accounting Policies [Line Items]            
Estimated useful lives of assets (in years)     5 years      
Maximum | Internally developed software            
Summary Of Significant Accounting Policies [Line Items]            
Estimated useful lives of assets (in years)     7 years      
Medicare | AlloSure Kidney            
Summary Of Significant Accounting Policies [Line Items]            
Revenue not yet recognized           $ 8,900,000
Reimbursement claims | claim           3,200
Medicare | Services Revenue | Customer Concentration Risk            
Summary Of Significant Accounting Policies [Line Items]            
Concentration risk, percentage (percent)     40.00% 53.00% 59.00%  
Medicare | Accounts Receivable | Credit Concentration Risk            
Summary Of Significant Accounting Policies [Line Items]            
Concentration risk, percentage (percent)     36.00% 27.00%    
Noridian | AlloSure Kidney            
Summary Of Significant Accounting Policies [Line Items]            
Total revenue   $ 7,800,000        
v3.24.0.1
Net Loss Per Share - Summary of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Numerator:      
Net loss used to compute basic net loss per share $ (190,284) $ (76,613) $ (30,662)
Net loss used to compute diluted net loss per share $ (190,284) $ (76,613) $ (30,662)
Denominator:      
Weighted-average shares used to compute basic net loss per share (in shares) 53,764,705 53,321,625 52,241,076
Weighted-average shares used to compute diluted net loss per share (in shares) 53,764,705 53,321,625 52,241,076
Net loss per share:      
Basic (in dollars per share) $ (3.54) $ (1.44) $ (0.59)
Diluted (in dollars per share) $ (3.54) $ (1.44) $ (0.59)
v3.24.0.1
Net Loss Per Share - Summary of Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (Details) - shares
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares) 8,056,578 6,017,524 3,914,422
Shares of common stock subject to outstanding options      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares) 3,055,208 2,921,925 1,863,633
Shares of common stock subject to outstanding common stock warrants      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares) 0 3,132 3,132
Restricted stock units      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Potential dilutive securities excluded from diluted net loss per share attributable to common stockholders (in shares) 5,001,370 3,092,467 2,047,657
v3.24.0.1
Net Loss Per Share - Additional Information (Details) - shares
Feb. 11, 2021
Jan. 25, 2021
Public Offering    
Schedule of Net Income (Loss) Per Share [Line Items]    
Number of shares issued in transaction (in shares)   1,923,077
Over-allotments    
Schedule of Net Income (Loss) Per Share [Line Items]    
Number of shares issued in transaction (in shares) 288,461  
v3.24.0.1
Fair Value Measurements - Summary of Fair Value of Financial Assets and Liabilities Measured on Recurring Basis (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Short-term liabilities:    
Contingent consideration $ 5,469 $ 1,025
Recurring    
Assets    
Money market funds 60,525 66,594
Corporate equity securities   2,076
Total 60,525 68,670
Short-term liabilities:    
Contingent consideration 5,469 1,025
Long-term liabilities:    
Contingent consideration 2,461 2,418
Common stock warrant liability   32
Total 7,930 3,475
Fair Value Measured Using - (Level 1) | Recurring    
Assets    
Money market funds 60,525 66,594
Corporate equity securities   2,076
Total 60,525 68,670
Short-term liabilities:    
Contingent consideration 0 0
Long-term liabilities:    
Contingent consideration 0 0
Common stock warrant liability   0
Total 0 0
Fair Value Measured Using - (Level 2) | Recurring    
Assets    
Money market funds 0 0
Corporate equity securities   0
Total 0 0
Short-term liabilities:    
Contingent consideration 0 0
Long-term liabilities:    
Contingent consideration 0 0
Common stock warrant liability   0
Total 0 0
Fair Value Measured Using - (Level 3) | Recurring    
Assets    
Money market funds 0 0
Corporate equity securities   0
Total 0 0
Short-term liabilities:    
Contingent consideration 5,469 1,025
Long-term liabilities:    
Contingent consideration 2,461 2,418
Common stock warrant liability   32
Total $ 7,930 $ 3,475
v3.24.0.1
Fair Value Measurements - Summary of Issuances, Changes in Fair Value and Classifications of Level 3 Financial Instruments (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Beginning balance $ 3,475 $ 5,480
Exercise of warrants (22)  
Ending balance 7,930 3,475
Common Stock Warrant Liability    
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Change in estimated fair value of common stock warrant liability (10) (107)
Contingent Consideration    
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Additions to contingent consideration 2,269 727
Payment related to contingent consideration (625) $ (2,625)
Contingent Consideration, Business Combination    
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Change in estimated fair value of common stock warrant liability 2,677  
Contingent Consideration, Asset Acquisition    
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Change in estimated fair value of common stock warrant liability $ 166  
v3.24.0.1
Fair Value Measurements - Additional Information (Details)
$ in Thousands
1 Months Ended 12 Months Ended
Dec. 31, 2023
USD ($)
Mar. 31, 2023
USD ($)
Dec. 31, 2023
USD ($)
Dec. 31, 2022
USD ($)
Dec. 31, 2021
USD ($)
Fair Value Measurement Inputs and Valuation Techniques [Line Items]          
Write-off of investments in convertible preferred shares   $ 1,000      
Proceeds from sale of equity securities $ 2,500   $ 2,460 $ 0 $ 0
Gain on disposal     $ 1,500    
Contingent consideration, measurement input, discount rate (percent)       0.12  
Minimum          
Fair Value Measurement Inputs and Valuation Techniques [Line Items]          
Contingent consideration, measurement input, discount rate (percent)     0.06    
Maximum          
Fair Value Measurement Inputs and Valuation Techniques [Line Items]          
Contingent consideration, measurement input, discount rate (percent)     0.12    
v3.24.0.1
Cash and Marketable Securities - Summary of Cash and Cash Equivalents (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Dec. 31, 2020
Cash and Cash Equivalents [Abstract]        
Cash and cash equivalents $ 82,197 $ 89,921 $ 348,485  
Restricted cash 586 522 211  
Total cash, cash equivalents, and restricted cash at the end of the period $ 82,783 $ 90,443 $ 348,696 $ 134,939
v3.24.0.1
Cash and Marketable Securities - Additional Information (Details)
$ in Millions
12 Months Ended
Dec. 31, 2023
USD ($)
Cash and Cash Equivalents [Abstract]  
Write-off of marketable debt securities $ 0.5
v3.24.0.1
Cash and Marketable Securities - Summary of Components of Marketable Securities (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Short-term marketable securities:    
Total $ 153,221 $ 203,168
Amortized Cost 153,221 203,168
Unrealized Holding Gains 2,749 232
Fair Value 155,970 203,400
Long-term marketable securities:    
Amortized Cost   5,000
Unrealized Holding Gains   (2,924)
Fair Value   2,076
Amortized Cost 153,221 208,168
Unrealized Holding Gains 2,749 (2,692)
Fair Value 155,970 205,476
U.S. agency securities    
Short-term marketable securities:    
Total 80,468 79,347
Unrealized holding gain 2,038 452
Debt securities, fair value 82,506 79,799
Corporate debt securities    
Short-term marketable securities:    
Total 72,753 123,821
Unrealized holding gain 711  
Unrealized holding loss   (220)
Debt securities, fair value $ 73,464 123,601
Corporate equity securities    
Long-term marketable securities:    
Corporate equity securities, amortized cost   5,000
Corporate equity securities, unrealized holding gains (losses)   (2,924)
Corporate equity securities   $ 2,076
v3.24.0.1
Cash and Marketable Securities - Summary of Maturity (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Cash and Cash Equivalents [Abstract]    
Within one year $ 153,221 $ 203,168
After one year through five years 0 0
Total $ 153,221 $ 203,168
v3.24.0.1
Business Combinations and Asset Acquisition - Additional Information (Details)
1 Months Ended
Aug. 09, 2023
USD ($)
asset
Jul. 31, 2023
USD ($)
Jan. 31, 2023
USD ($)
Dec. 31, 2023
USD ($)
Dec. 31, 2022
USD ($)
Dec. 31, 2021
USD ($)
Business Acquisition [Line Items]            
Goodwill       $ 40,336,000 $ 37,523,000 $ 36,983,000
Asset acquisition, consideration transferred $ 2,600,000          
Payments to acquire productive assets 1,800,000          
Contingent consideration 500,000          
Transaction cost $ 300,000          
Number of assets acquired | asset 1          
HLA Data Systems            
Business Acquisition [Line Items]            
Short term contingent consideration     $ 1,300,000      
Acquisition related costs     400,000      
Goodwill     2,100,000      
Goodwill expected to be deductible for income tax purposes     $ 0      
HLA Data Systems | Discount rate            
Business Acquisition [Line Items]            
Intangible asset, measurement input     0.24      
HLA Data Systems | Developed Technology Rights [Member] | Measurement Input, Royalty Rate            
Business Acquisition [Line Items]            
Intangible asset, measurement input     0.10      
HLA Data Systems | Trademarks [Member] | Measurement Input, Royalty Rate            
Business Acquisition [Line Items]            
Intangible asset, measurement input     0.02      
MediGO            
Business Acquisition [Line Items]            
Short term contingent consideration   $ 300,000        
Acquisition related costs   300,000        
Goodwill   600,000        
Goodwill expected to be deductible for income tax purposes   $ 0        
MediGO | Discount rate            
Business Acquisition [Line Items]            
Intangible asset, measurement input   0.25        
MediGO | Developed Technology Rights [Member] | Measurement Input, Royalty Rate            
Business Acquisition [Line Items]            
Intangible asset, measurement input   0.10        
MediGO | Trademarks [Member] | Measurement Input, Royalty Rate            
Business Acquisition [Line Items]            
Intangible asset, measurement input   0.02        
v3.24.0.1
Business Combinations and Asset Acquisition - Summary of Identified Intangible Assets Acquired at Acquisition Date (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Jul. 31, 2023
Jan. 31, 2023
Dec. 31, 2022
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure   $ 810    
HLA Data Systems        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure     $ 4,100  
MediGO        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure   2,020    
Customer relationships        
Business Acquisition [Line Items]        
Weighted Average Remaining Useful Life (In Years) 9 years 2 months 12 days     9 years
Customer relationships | HLA Data Systems        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure     $ 3,010  
Weighted Average Remaining Useful Life (In Years)     13 years  
Customer relationships | MediGO        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure   $ 810    
Weighted Average Remaining Useful Life (In Years)   17 years    
Developed Technology Rights [Member] | HLA Data Systems        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure     $ 770  
Weighted Average Remaining Useful Life (In Years)     11 years  
Developed Technology Rights [Member] | MediGO        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure   $ 850    
Weighted Average Remaining Useful Life (In Years)   12 years    
Trademarks [Member] | HLA Data Systems        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure     $ 320  
Weighted Average Remaining Useful Life (In Years)     17 years  
Trademarks [Member] | MediGO        
Business Acquisition [Line Items]        
Finite-Lived Intangible Assets, Fair Value Disclosure   $ 360    
Weighted Average Remaining Useful Life (In Years)   17 years    
v3.24.0.1
Business Combinations and Asset Acquisition - Summary of Consideration Paid and Provisional Amounts of Assets Acquired and Liabilities Assumed Recognized at Their Estimated Fair Value (Details) - USD ($)
$ in Thousands
1 Months Ended
Jul. 31, 2023
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Business Acquisition [Line Items]        
Goodwill   $ 40,336 $ 37,523 $ 36,983
HLA Data Systems And MediGO        
Business Acquisition [Line Items]        
Payments to Acquire Businesses, Gross $ 6,682      
Business Combination, Consideration Transferred, Total 6,682      
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Assets 1,413      
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Finite-Lived Intangibles 6,120      
Current liabilities (1,060)      
Other current liabilities (810)      
Contingent considerations (1,620)      
Other liabilities (7)      
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Net, Total 4,036      
Goodwill 2,646      
Business Combination, Recognized Identifiable Assets Acquired, Goodwill, and Liabilities Assumed, Net, Total $ 6,682      
v3.24.0.1
Goodwill and Intangible Assets - Additional Information (Details) - USD ($)
3 Months Ended 12 Months Ended
Sep. 30, 2023
Dec. 31, 2023
Goodwill And Intangible Assets [Line Items]    
Goodwill impairment $ 0 $ 0
Accumulated goodwill impairment   $ 0
Discount rate    
Goodwill And Intangible Assets [Line Items]    
Discount rate (percent) 16.40%  
v3.24.0.1
Goodwill and Intangible Assets - Summary of Goodwill (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Goodwill [Roll Forward]    
Beginning balance $ 37,523 $ 36,983
Goodwill acquired 2,646 540
Remeasurement adjustment 167 0
Ending balance $ 40,336 $ 37,523
v3.24.0.1
Goodwill and Intangible Assets - Summary of Intangible Assets (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Intangible assets with finite lives:    
Gross Carrying Amount $ 79,884 $ 73,764
Accumulated Amortization (33,643) (27,175)
Foreign Currency Translation (4,516) (4,788)
Total future amortization expense 41,725 41,801
Intangible assets with indefinite lives    
Net carrying amount 3,976  
Intangible Assets, Net (Excluding Goodwill)    
Total intangible assets - gross carrying amount 83,860 75,014
Total intangible assets, net 45,701 43,051
Acquired in-process technology    
Intangible assets with indefinite lives    
Net carrying amount 1,250 1,250
Favorable license agreement    
Intangible assets with indefinite lives    
Net carrying amount 2,726  
Acquired and developed technology    
Intangible assets with finite lives:    
Gross Carrying Amount 37,367 35,747
Accumulated Amortization (18,340) (15,138)
Foreign Currency Translation (2,269) (2,369)
Total future amortization expense $ 16,758 $ 18,240
Weighted Average Remaining Useful Life (In Years) 7 years 2 months 12 days 7 years 6 months
Customer relationships    
Intangible assets with finite lives:    
Gross Carrying Amount $ 25,718 $ 21,898
Accumulated Amortization (9,094) (7,459)
Foreign Currency Translation (1,959) (2,104)
Total future amortization expense $ 14,665 $ 12,335
Weighted Average Remaining Useful Life (In Years) 9 years 2 months 12 days 9 years
Commercialization rights    
Intangible assets with finite lives:    
Gross Carrying Amount $ 11,579 $ 11,579
Accumulated Amortization (4,496) (3,233)
Foreign Currency Translation 0 0
Total future amortization expense $ 7,083 $ 8,346
Weighted Average Remaining Useful Life (In Years) 5 years 7 months 6 days 6 years 7 months 6 days
Trademarks and tradenames    
Intangible assets with finite lives:    
Gross Carrying Amount $ 5,220 $ 4,540
Accumulated Amortization (1,713) (1,345)
Foreign Currency Translation (288) (315)
Total future amortization expense $ 3,219 $ 2,880
Weighted Average Remaining Useful Life (In Years) 9 years 3 months 18 days 8 years 6 months
v3.24.0.1
Goodwill and Intangible Assets - Summary of Finite-Lived Intangible Assets Amortization Expense (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Indefinite-lived Intangible Assets [Line Items]      
Amortization expense of intangible assets $ 6,467 $ 6,229 $ 5,796
Cost of testing services      
Indefinite-lived Intangible Assets [Line Items]      
Amortization expense of intangible assets 1,316 1,316 1,316
Cost of product      
Indefinite-lived Intangible Assets [Line Items]      
Amortization expense of intangible assets 1,655 1,716 1,905
Cost of patient and digital solutions      
Indefinite-lived Intangible Assets [Line Items]      
Amortization expense of intangible assets 1,039 945 684
Sales and marketing      
Indefinite-lived Intangible Assets [Line Items]      
Amortization expense of intangible assets $ 2,457 $ 2,252 $ 1,891
v3.24.0.1
Goodwill and Intangible Assets - Summary of Estimated Future Amortization Expense of Intangible Assets (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
2024 $ 6,438  
2025 6,269  
2026 5,302  
2027 5,289  
2028 5,289  
Thereafter 13,138  
Total future amortization expense 41,725 $ 41,801
Cost of Testing Services    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
2024 1,316  
2025 1,316  
2026 1,316  
2027 1,316  
2028 1,316  
Thereafter 1,509  
Total future amortization expense 8,089  
Cost of Product    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
2024 1,715  
2025 1,715  
2026 751  
2027 751  
2028 751  
Thereafter 2,567  
Total future amortization expense 8,250  
Cost of Patient and Digital Solutions    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
2024 850  
2025 681  
2026 681  
2027 681  
2028 681  
Thereafter 1,462  
Total future amortization expense 5,036  
Sales and Marketing    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
2024 2,557  
2025 2,557  
2026 2,554  
2027 2,541  
2028 2,541  
Thereafter 7,600  
Total future amortization expense $ 20,350  
v3.24.0.1
Balance Sheet Components - Summary of Inventory (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Finished goods $ 3,658 $ 2,962
Work in progress 5,191 4,306
Raw materials 10,622 11,964
Total inventory $ 19,471 $ 19,232
v3.24.0.1
Balance Sheet Components - Summary of Components of Property and Equipment (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Property, Plant and Equipment [Line Items]    
Property and equipment $ 67,509 $ 59,953
Less: Accumulated depreciation and amortization (32,263) (24,424)
Property and equipment, net 35,246 35,529
Leasehold improvements    
Property, Plant and Equipment [Line Items]    
Property and equipment 18,259 17,389
Machinery and equipment    
Property, Plant and Equipment [Line Items]    
Property and equipment 18,051 16,294
Internally developed software    
Property, Plant and Equipment [Line Items]    
Property and equipment 15,116 10,893
Construction in progress    
Property, Plant and Equipment [Line Items]    
Property and equipment 8,306 7,639
Computer and office equipment    
Property, Plant and Equipment [Line Items]    
Property and equipment 5,609 5,570
Furniture and fixtures    
Property, Plant and Equipment [Line Items]    
Property and equipment $ 2,168 $ 2,168
v3.24.0.1
Balance Sheet Components - Additional Information (Details) - USD ($)
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]      
Depreciation expense $ 7,900,000 $ 5,200,000 $ 2,700,000
Finance lease, ROU asset 0    
Accumulated depreciation finance lease assets 600,000 600,000  
Amortization expense, included in depreciation and amortization expense $ 0.0 $ 100,000 $ 100,000
v3.24.0.1
Balance Sheet Components - Summary of Components of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Clinical studies $ 15,744 $ 14,816
Short-term lease liability 5,943 5,591
Professional fees 5,911 6,115
Contingent consideration 5,469 1,025
Deferred revenue 4,748 5,342
Laboratory processing fees and materials 2,890 2,189
Accrued royalty 348 4,633
Deferred payments for intangible assets 920 2,062
Accrued shipping expenses 335 489
License and other collaboration fees 250 1,000
Capital expenditures 151 1,316
Other accrued expenses 2,788 4,553
Total accrued and other liabilities $ 45,497 $ 49,131
v3.24.0.1
Commitments and Contingencies - Additional Information (Details)
1 Months Ended
May 13, 2022
complaint
Mar. 14, 2022
USD ($)
Jul. 31, 2023
May 31, 2023
Dec. 31, 2022
USD ($)
Jun. 30, 2022
USD ($)
Jun. 30, 2014
milestone_payment
Dec. 31, 2023
USD ($)
Jun. 30, 2023
USD ($)
Feb. 28, 2022
Dec. 31, 2021
USD ($)
Dec. 31, 2020
USD ($)
Loss Contingencies [Line Items]                        
ROU assets         $ 34,689,000     $ 29,891,000        
Short-term lease liability         5,591,000     5,943,000        
Operating lease liability, less current portion         $ 33,406,000     $ 28,278,000        
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]         Accrued and other liabilities     Accrued and other liabilities        
Decrease in right-of-use asset and lease liability           $ 500,000            
Unrecognized tax benefits         $ 5,436,000     $ 6,184,000     $ 4,156,000 $ 4,416,000
Cumulative or accrued interest and penalties related to unrecognized tax benefits               200,000        
Insurance matter         $ 15,000,000              
CAREDX, INC. vs Natera Inc.                        
Loss Contingencies [Line Items]                        
Litigation settlement   $ 44,900,000                    
Number of claims filed | complaint 2                      
CAREDX, INC. vs Natera Inc. | Compensatory Damages                        
Loss Contingencies [Line Items]                        
Litigation settlement   21,200,000                    
CAREDX, INC. vs Natera Inc. | Punitive Damages                        
Loss Contingencies [Line Items]                        
Litigation settlement   $ 23,700,000                    
Noncurrent Liabilities                        
Loss Contingencies [Line Items]                        
Unrecognized tax benefits               200,000        
Cibiltech Commitments                        
Loss Contingencies [Line Items]                        
Outstanding obligation               0 $ 400,000      
Stanford License Royalty Commitment                        
Loss Contingencies [Line Items]                        
Number of milestone payments | milestone_payment             6          
Period after termination       90 days                
Outstanding obligation               $ 0        
iBox License and Collaboration Agreement                        
Loss Contingencies [Line Items]                        
License period     4 years                  
Minimum                        
Loss Contingencies [Line Items]                        
Lessee, operating lease, term of contract (in years)           2 years       2 years    
Operating lease, extension period (in years)           5 years       5 years    
Maximum                        
Loss Contingencies [Line Items]                        
Lessee, operating lease, term of contract (in years)           10 years 6 months       10 years 6 months    
Operating lease, extension period (in years)           10 years       10 years    
v3.24.0.1
Commitments and Contingencies - Summary of Lease Cost (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Commitments and Contingencies Disclosure [Abstract]      
Operating lease cost $ 7,936 $ 6,716 $ 5,134
Finance lease cost 0 0 53
Total lease cost $ 7,936 $ 6,716 $ 5,187
Weighted-average remaining lease term - Operating leases (in years) 5 years 5 months 4 days 6 years 3 months 3 days  
Weighted-average discount rate - Operating leases (%) 7.10% 7.10%  
v3.24.0.1
Commitments and Contingencies - Summarizes ROU Assets and Lease Liabilities for Lease Agreements (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Loss Contingencies [Line Items]    
ROU assets $ 29,891 $ 34,689
Lease liabilities 34,221  
Leases, Commenced In July 2022    
Loss Contingencies [Line Items]    
ROU assets 12,073 14,321
Lease liabilities 13,221 15,302
Leases, Commenced In August 2022    
Loss Contingencies [Line Items]    
ROU assets 5,347 5,814
Lease liabilities $ 5,627 $ 6,005
v3.24.0.1
Commitments and Contingencies - Summary of Noncash Information (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Cash paid for amounts included in the measurement of lease liabilities      
Operating cash flows used for operating leases $ 5,454 $ 3,665 $ 2,580
Operating cash flows used for finance leases 0 0 63
Total $ 5,454 $ 3,665 $ 2,643
v3.24.0.1
Commitments and Contingencies - Summary of Maturities of Operating Lease Liabilities (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Operating Leases    
2024 $ 7,993  
2025 7,875  
2026 7,124  
2027 7,274  
2028 6,599  
Thereafter 4,115  
Total lease payments 40,980  
Less imputed interest 6,759  
Present value of future minimum lease payments 34,221  
Less operating lease liability, current portion 5,943 $ 5,591
Operating lease liability, long-term portion $ 28,278 $ 33,406
v3.24.0.1
Stockholders' Equity (Details) - USD ($)
$ / shares in Units, $ in Millions
12 Months Ended
Dec. 08, 2022
Dec. 03, 2022
Feb. 11, 2021
Jan. 25, 2021
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Class of Stock [Line Items]              
Stock repurchase program, authorized amount   $ 50.0          
Stock repurchase program, period in force (in years) 2 years 2 years          
Number of common stock purchased (in shares)         2,942,997 50,051  
Stock repurchased value         $ 27.5 $ 0.6  
Stock repurchase program, remaining authorized repurchase amount         $ 21.9    
Preferred stock, shares issued (in shares)         0 0 0
Public Offering              
Class of Stock [Line Items]              
Number of shares issued in transaction (in shares)       1,923,077      
Common stock offer (in dollars per share)       $ 91.00      
Consideration received on transaction       $ 164.0      
Over-allotments              
Class of Stock [Line Items]              
Number of shares issued in transaction (in shares)     288,461        
Consideration received on transaction     $ 24.7        
v3.24.0.1
401(K) Plan (Details) - USD ($)
$ in Millions
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Retirement Benefits [Abstract]      
Defined benefit plan, type Postemployment Retirement Benefits [Member]    
Expense incurred related to plan $ 1.7 $ 1.8 $ 1.4
v3.24.0.1
Warrants - Additional Information (Details) - USD ($)
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Warrants and Rights Note Disclosure [Abstract]      
Number of warrants exercised (in shares) 3,000 0  
Proceeds from exercise of warrants $ 4,000 $ 0 $ 4,000
Warrants to purchase common stock were outstanding $ 0 $ 32,000  
v3.24.0.1
Stock Incentive Plans - Additional Information (Details) - USD ($)
12 Months Ended
Jan. 02, 2024
Jul. 06, 2023
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
May 10, 2023
Apr. 21, 2016
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares reserved for future issuance of common stock (in shares)           250,000,000  
Total intrinsic value of options exercised     $ 100,000 $ 1,600,000 $ 42,900,000    
Total unrecognized compensation costs related to stock options and RSUs     $ 17,500,000        
Stock options and RSUs and PSUs expected weighted average period (in years)     2 years 3 months 3 days        
Number of shares outstanding (in shares)     3,055,208 2,921,925      
Weighted average fair value of options to purchase common stock granted (in dollars per share)     $ 8.63 $ 19.51 $ 52.65    
Total fair value of options vested during period     $ 18,400,000        
Shares available for issuance (in shares)     869,111 1,490,462      
Stock-based compensation expense     $ 49,086,000 $ 46,553,000 $ 36,081,000    
Share-based compensation expense, tax benefit recognized     0        
General and administrative              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock-based compensation expense     $ 25,664,000 20,779,000 14,403,000    
Non Employee Director              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Number of shares issued (in shares)     310,609        
Fair value of shares issued     $ 2,500,000        
Non Employee Director | General and administrative              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock-based compensation expense     $ 200,000 $ 400,000 $ 300,000    
2019 Equity Incentive Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Maximum number of common stock shares that might be granted (in shares)     135,904        
2014 Equity Incentive Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares reserved for future issuance of common stock (in shares)     670,455        
2016 Inducement Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares reserved for future issuance of common stock (in shares)     62,752        
Maximum number of common stock shares that might be granted (in shares)             155,500
2014 Employee Stock Purchase Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Maximum portion of earning an employee may contribute to the ESPP Plan (percent)     15.00%        
Maximum value of shares which an employee can purchase per calendar year     $ 25,000        
Offering period for employee stock purchases     6 months        
Applicable exercise date an offering period shall be equal to percentage of the lower of fair market value of common stock (percent)     85.00%        
Shares issued under ESPP (in shares)   143,817          
Aggregate proceeds from the issuance of shares   $ 1,000,000          
2014 Employee Stock Purchase Plan | Subsequent Event              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares issued under ESPP (in shares) 73,759            
Aggregate proceeds from the issuance of shares $ 500,000            
Employee Stock Purchase Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares issued under ESPP (in shares)     190,842 93,422      
Aggregate proceeds from the issuance of shares     $ 1,500,000 $ 3,000,000      
Shares available for issuance (in shares)     583,906        
Restricted stock units              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Total fair value of RSUs vested during the period     $ 9,500,000        
Intrinsic value of RSUs     61,600,000        
Total unrecognized compensation costs related to stock options and RSUs     $ 55,800,000        
Stock options and RSUs and PSUs expected weighted average period (in years)     2 years 2 months 23 days        
Restricted stock units | 2019 Equity Incentive Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Expiration period (in years)     10 years        
Termination of employment     3 months        
Vesting period (in years)     4 years        
Performance Shares              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Vesting period (in years)     2 years        
Stock options and RSUs and PSUs expected weighted average period (in years)     1 year 3 days 1 year 1 month 28 days      
Number of shares outstanding (in shares)     449,983 160,538      
Stock Options | 2019 Equity Incentive Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Vesting period (in years)     4 years        
v3.24.0.1
Stock Incentive Plans - Summary of Options, RSUs Activity under 2014 Equity Incentive Plan and 2016 Inducement Plan and Related Information (Details)
12 Months Ended
Dec. 31, 2023
$ / shares
shares
Shares Available for Grant  
Beginning balance (in shares) 1,490,462
Additional options authorized (in shares) 2,141,330
Common stock awards for services (in shares) (21,965)
RSUs granted (in shares) (4,028,424)
Options granted (in shares) (680,788)
Repurchases of common stock under employee incentive plans (in shares) 322,163
RSUs forfeited (in shares) 1,126,731
Options forfeited (in shares) 265,395
Options expired (in shares) 254,207
Ending balance (in shares) 869,111
RSUs granted (in shares) 4,028,424
RSUs forfeited (in shares) (1,126,731)
Stock Options Outstanding  
Beginning balance (in shares) 2,921,925
Options granted (in shares) 680,788
Options exercised (in shares) (27,903)
Options forfeited (in shares) (265,395)
Options expired (in shares) (254,207)
Ending balance (in shares) 3,055,208
Weighted average exercise price, beginning balance (in dollars per share) | $ / shares $ 28.13
Options granted, weighted average exercise price (in dollars per share) | $ / shares 12.60
Options exercised, weighted average exercise price (in dollars per share) | $ / shares 4.29
Options forfeited, weighted-average exercise price (in dollars per share) | $ / shares 26.90
Options expired, weighted-average exercise price (in dollars per share) | $ / shares 27.13
Weighted average exercise price, ending balance (in dollars per share) | $ / shares $ 25.21
Restricted stock units  
Shares Available for Grant  
RSUs granted (in shares) (4,028,424)
RSUs forfeited (in shares) 1,126,731
RSUs, beginning balance (in shares) 3,094,396
RSUs granted (in shares) 4,028,424
RSUs vested (in shares) (989,314)
RSUs forfeited (in shares) (1,126,731)
RSUs, ending balance (in shares) 5,006,775
Stock Options Outstanding  
Outstanding, beginning balance, weighted-average grant date fair value (in dollars per share) | $ / shares $ 37.39
RSUs granted, weighted-average grant date fair value (in dollars per share) | $ / shares 10.52
RSUs vested, weighted-average grant date fair value (in dollars per share) | $ / shares 36.43
RSUs forfeited, weighted-average grant date fair value (in dollars per share) | $ / shares 22.92
Outstanding, ending balance, weighted-average grant date fair value (in dollars per share) | $ / shares $ 19.02
v3.24.0.1
Stock Incentive Plans - Summary of Options Outstanding Vested and Expected to Vest (Details)
$ / shares in Units, $ in Thousands
12 Months Ended
Dec. 31, 2023
USD ($)
$ / shares
shares
Share-Based Payment Arrangement [Abstract]  
Vested (in shares) | shares 1,786
Expected to vest (in shares) | shares 1,191
Total (in shares) | shares 2,977
Vested (in dollars per share) | $ / shares $ 26.21
Expected to vest (in dollars per share) | $ / shares $ 23.56
Vested, weighted average remaining life (years) 6 years 3 months 7 days
Expected to vest, weighted average remaining contractual life (years) 8 years 7 months 2 days
Vested, aggregate intrinsic value | $ $ 1,751
Expected to vest, aggregate intrinsic value | $ 530
Aggregate Intrinsic Value, Total | $ $ 2,281
v3.24.0.1
Stock Incentive Plans - Summary of Weighted-Average Assumptions Used to Estimated Fair Value of Share-Based Awards (Details)
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Employee Stock Purchase Plan      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Expected term (in years) 6 months 6 months 6 months
Expected dividend yield 0.00% 0.00% 0.00%
Risk-free interest rate, minimum 5.26% 2.51% 0.09%
Risk-free interest rate, maximum 5.47% 4.76% 0.19%
Employee Stock Purchase Plan | Minimum      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Expected volatility 75.91% 67.79% 53.10%
Employee Stock Purchase Plan | Maximum      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Expected volatility 93.38% 77.88% 67.79%
Shares of common stock subject to outstanding options      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Expected term (in years) 5 years 7 months 9 days 5 years 11 months 15 days 5 years 11 months 8 days
Expected volatility 77.86% 77.62% 77.70%
Risk-free interest rate 3.67% 2.74% 0.80%
Expected dividend yield 0.00% 0.00% 0.00%
v3.24.0.1
Stock Incentive Plans - Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense $ 49,086 $ 46,553 $ 36,081
Cost of Testing Services      
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense 1,854 1,529 2,358
Cost of Product      
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense 1,165 1,120 579
Cost of Patient and Digital Solutions      
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense 1,377 1,331 728
Research and development      
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense 6,556 7,391 7,126
Sales and marketing      
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense 12,470 14,403 10,887
General and administrative      
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]      
Stock-based compensation expense $ 25,664 $ 20,779 $ 14,403
v3.24.0.1
Income Taxes - Summary of Loss Before Income Taxes (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Income Tax Disclosure [Abstract]      
United States $ (188,421) $ (73,089) $ (27,921)
Foreign (1,722) (3,145) (4,167)
Loss before income taxes $ (190,143) $ (76,234) $ (32,088)
v3.24.0.1
Income Taxes - Summary of Components of Provision for (Benefit from) Income Taxes (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Current      
Federal $ (117) $ 145 $ 89
State 186 328 2
Foreign 0 184 (139)
Total current income tax expense (benefit) 69 657 (48)
Deferred      
Federal 184 (130) (409)
State (112) 75 (127)
Foreign 0 (223) (842)
Total deferred income tax expense (benefit) 72 (278) (1,378)
Income tax expense (benefit) $ 141 $ 379 $ (1,426)
v3.24.0.1
Income Taxes - Summary of Provision for Tax Differed from Amounts Computed by Applying U.S. Federal Income Tax Rate to Loss Before Income (Details)
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Effective Income Tax Rate Reconciliation, Nondeductible Expense, Depreciation and Amortization, Percent [Abstract]      
Federal tax statutory rate 21.00% 21.00% 21.00%
Stock-based compensation (3.80%) (2.80%) 38.80%
Change in valuation allowance (18.10%) (16.90%) 86.40%
Foreign rate differential 0.20% (0.20%) 0.70%
Non-deductible executive compensation (0.40%) (2.10%) (23.40%)
Research credits 0.40% 1.80% 6.90%
Changes in net operating loss carryforwards, including expirations 0.80% (0.50%) (125.10%)
Other (0.20%) (0.80%) (0.90%)
Effective income tax rate (0.10%) (0.50%) 4.40%
v3.24.0.1
Income Taxes - Summary of Deferred Income Tax Assets and Liabilities (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Deferred tax assets:    
Net operating loss carryforwards $ 30,260 $ 26,658
Tax credit carryforwards 10,317 9,138
Accruals 26,256 2,971
Lease liability 7,947 9,250
Section 174 capitalized costs 31,724 20,602
Stock-based compensation 12,799 7,798
Other 1,351 959
Gross deferred tax assets 120,654 77,376
Valuation allowance (102,865) (59,499)
Total deferred tax assets 17,789 17,877
Deferred tax liabilities:    
Purchased intangibles (6,112) (6,615)
Operating leases right-of-use assets (6,914) (8,189)
Property and equipment (4,443) (2,548)
Other (456) (497)
Total deferred tax liabilities (17,925) (17,849)
Net deferred tax (liabilities) assets   $ 28
Net deferred tax (liabilities) assets $ (136)  
v3.24.0.1
Income Taxes - Additional Information (Details) - USD ($)
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Dec. 31, 2020
Income Taxes Disclosure [Line Items]        
Increase (decrease) in valuation allowance $ 43,400,000 $ 13,900,000    
Net unrecognized tax benefit would impact the effective tax rate 0      
Net unrecognized tax benefit 6,184,000 $ 5,436,000 $ 4,156,000 $ 4,416,000
Cumulative or accrued interest and penalties related to unrecognized tax benefits 200,000      
Domestic Federal        
Income Taxes Disclosure [Line Items]        
Net operating loss carryforwards 109,100,000      
Tax credit carryforwards 11,500,000      
Domestic State        
Income Taxes Disclosure [Line Items]        
Net operating loss carryforwards 77,600,000      
Domestic State | California        
Income Taxes Disclosure [Line Items]        
Tax credit carryforwards 11,100,000      
Foreign        
Income Taxes Disclosure [Line Items]        
Net operating loss carryforwards $ 12,000,000      
Statutes of limitation for income tax returns start year (in years) 3 years      
Statutes of limitation for income tax returns end year (in years) 6 years      
v3.24.0.1
Income Taxes - Summary of Reconciliation of Unrecognized Tax Benefits (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward]      
Balance at the beginning of the year $ 5,436 $ 4,156 $ 4,416
Additions based on tax positions related to the current year 839 1,255 805
Additions based on tax positions related to prior years 0 25 130
Decreases based on tax positions related to prior years (91) 0 (1,195)
Balance at the end of the year $ 6,184 $ 5,436 $ 4,156
v3.24.0.1
Segment Reporting - Additional Information (Details)
12 Months Ended
Dec. 31, 2023
segment
Segment Reporting [Abstract]  
Number of operating segments 1
Number of reportable segments 1
v3.24.0.1
Segment Reporting - Summary of Reportable Revenues by Geographic Regions (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Segment Reporting Information [Line Items]      
Revenues $ 280,324 $ 321,793 $ 296,397
United States      
Segment Reporting Information [Line Items]      
Revenues 265,630 307,543 282,009
Europe      
Segment Reporting Information [Line Items]      
Revenues 10,167 9,549 9,822
Rest of World      
Segment Reporting Information [Line Items]      
Revenues 4,527 4,701 4,566
Testing services revenue      
Segment Reporting Information [Line Items]      
Revenues 209,685 263,748 259,285
Testing services revenue | United States      
Segment Reporting Information [Line Items]      
Revenues 209,158 262,959 258,412
Testing services revenue | Rest of World      
Segment Reporting Information [Line Items]      
Revenues 527 789 873
Product revenue      
Segment Reporting Information [Line Items]      
Revenues 33,517 29,251 26,832
Product revenue | United States      
Segment Reporting Information [Line Items]      
Revenues 19,753 16,409 13,512
Product revenue | Europe      
Segment Reporting Information [Line Items]      
Revenues 9,901 9,081 9,740
Product revenue | Rest of World      
Segment Reporting Information [Line Items]      
Revenues 3,863 3,761 3,580
Patient and digital solutions      
Segment Reporting Information [Line Items]      
Revenues 37,122 28,794 10,280
Patient and digital solutions | United States      
Segment Reporting Information [Line Items]      
Revenues 36,719 28,175 10,085
Patient and digital solutions | Europe      
Segment Reporting Information [Line Items]      
Revenues 266 468 82
Patient and digital solutions | Rest of World      
Segment Reporting Information [Line Items]      
Revenues $ 137 $ 151 $ 113
v3.24.0.1
Segment Reporting - Summary of Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Dec. 31, 2022
Segment Reporting Information [Line Items]    
Long-lived assets $ 35,246 $ 35,529
United States    
Segment Reporting Information [Line Items]    
Long-lived assets 34,714 35,020
Europe    
Segment Reporting Information [Line Items]    
Long-lived assets 476 405
Rest of World    
Segment Reporting Information [Line Items]    
Long-lived assets $ 56 $ 104
v3.24.0.1
Restructuring (Details)
$ in Thousands
1 Months Ended 12 Months Ended
Jan. 31, 2023
location
Dec. 31, 2023
USD ($)
Dec. 31, 2022
USD ($)
Dec. 31, 2021
USD ($)
Restructuring Cost and Reserve [Line Items]        
Number of locations expected to be discontinued under the restructuring plan | location 1      
Numberof locations | location 2      
Restructuring costs | $   $ 2,320 $ 0 $ 0
Employee Severance        
Restructuring Cost and Reserve [Line Items]        
Restructuring costs | $   $ 2,200    
v3.24.0.1
Subsequent Events (Details) - USD ($)
$ in Thousands
12 Months Ended
Jan. 26, 2024
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2021
Subsequent Event [Line Items]        
Litigation expense   $ 96,300 $ 0 $ 0
CAREDX, INC. vs Natera Inc.        
Subsequent Event [Line Items]        
Liability for damages awarded   96,300    
Litigation expense   $ 96,300    
Subsequent Event | CAREDX, INC. vs Natera Inc.        
Subsequent Event [Line Items]        
Loss contingency, damages awarded, value $ 96,300