CAREDX, INC., 10-Q filed on 11/4/2024
Quarterly Report
v3.24.3
Cover - shares
 9 Months Ended
Sep. 30, 2024
Oct. 31, 2024
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2024  
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, 4th Floor  
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 $0.001 per share  
Trading Symbol CDNA  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Accelerated Filer  
Entity Small Business false  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   53,633,871
Amendment Flag false  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Entity Central Index Key 0001217234  
Current Fiscal Year End Date --12-31  
v3.24.3
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 95,400 $ 82,197
Marketable securities 145,453 153,221
Accounts receivable 66,627 51,061
Inventory 19,263 19,471
Prepaid and other current assets 7,344 7,763
Total current assets 334,087 313,713
Property and equipment, net 34,015 35,246
Operating leases right-of-use assets 25,823 29,891
Intangible assets, net 40,361 45,701
Goodwill 40,336 40,336
Restricted cash 592 586
Other assets 1,771 1,353
Total assets 476,985 466,826
Current liabilities:    
Accounts payable 6,239 12,872
Accrued compensation 29,915 19,703
Accrued and other liabilities 45,286 45,497
Total current liabilities 81,440 78,072
Deferred tax liability 202 136
Deferred payments for intangible assets 1,310 2,461
Operating lease liability, less current portion 23,841 28,278
Other liabilities 96,946 96,551
Total liabilities 203,739 205,498
Commitments and contingencies (Note 9)
Stockholders’ equity:    
Preferred stock: $0.001 par value; 10,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023 0 0
Common stock: $0.001 par value; 100,000,000 shares authorized at September 30, 2024 and December 31, 2023; 53,106,871 and 51,503,377 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 50 49
Additional paid-in capital 984,627 946,511
Accumulated other comprehensive loss (7,179) (6,963)
Accumulated deficit (704,252) (678,269)
Total stockholders’ equity 273,246 261,328
Total liabilities and stockholders’ equity $ 476,985 $ 466,826
v3.24.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Sep. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Preferred stock, par value (in usd 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 usd per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 100,000,000 100,000,000
Common stock, shares issued (in shares) 53,106,871 51,503,377
Common stock, shares outstanding (in shares) 53,106,871 51,503,377
v3.24.3
Condensed Consolidated Statements of Operations - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Revenue:        
Total revenue $ 82,883 $ 67,192 $ 247,206 $ 214,755
Operating expenses:        
Research and development 17,486 19,000 55,875 63,590
Sales and marketing 19,802 18,474 60,634 63,335
General and administrative 28,515 33,968 83,104 91,327
Restructuring costs 0 0 68 848
Total operating expenses 93,375 95,975 281,133 295,486
Loss from operations (10,492) (28,783) (33,927) (80,731)
Other income:        
Interest income, net 3,001 3,171 8,712 8,708
Change in estimated fair value of common stock warrant liability 0 0 0 10
Other income (expense), net 283 2,047 (107) (198)
Total other income 3,284 5,218 8,605 8,520
Loss before income taxes (7,208) (23,565) (25,322) (72,211)
Income tax (expense) benefit (200) 80 (139) 24
Net loss $ (7,408) $ (23,485) $ (25,461) $ (72,187)
Net loss per share (Note 3):        
Basic (in dollars per share) $ (0.14) $ (0.43) $ (0.49) $ (1.34)
Diluted (in dollars per share) $ (0.14) $ (0.43) $ (0.49) $ (1.34)
Weighted-average shares used to compute net loss per share:        
Basic (in shares) 52,903,338 54,178,759 52,266,106 53,891,374
Diluted (in shares) 52,903,338 54,178,759 52,266,106 53,891,374
Testing services revenue        
Revenue:        
Total revenue $ 60,807 $ 47,784 $ 185,562 $ 162,982
Operating expenses:        
Cost of testing services, product, digital, and other 13,447 13,217 41,387 43,837
Product revenue        
Revenue:        
Total revenue 10,212 9,536 29,416 24,273
Operating expenses:        
Cost of testing services, product, digital, and other 6,212 4,750 17,801 12,742
Patient and digital solutions revenue        
Revenue:        
Total revenue 11,864 9,872 32,228 27,500
Operating expenses:        
Cost of testing services, product, digital, and other $ 7,913 $ 6,566 $ 22,264 $ 19,807
v3.24.3
Condensed Consolidated Statements of Comprehensive Loss - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Statement of Comprehensive Income [Abstract]        
Net loss $ (7,408) $ (23,485) $ (25,461) $ (72,187)
Other comprehensive gain (loss):        
Foreign currency translation adjustment, net of tax 785 (220) (216) (1,167)
Comprehensive loss $ (6,623) $ (23,705) $ (25,677) $ (73,354)
v3.24.3
Condensed Consolidated Statements of 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, 2022   53,533,250      
Beginning 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)   47,025      
Issuance of common stock under employee stock purchase plan 456   456    
Repurchase and retirement of common stock (in shares)   (59,472)      
Repurchase and retirement of common stock (690)       (690)
RSU settlements, net of shares withheld (in shares)   123,910      
RSU settlements, net of shares withheld (785)   (785)    
Issuance of common stock for services (in shares)   7,649      
Issuance of common stock for services 93   93    
Issuance of common stock for cash upon exercise of stock options (in shares)   820      
Issuance of common stock for cash upon exercise of stock options 2   2    
Employee stock-based compensation expense 13,719   13,719    
Foreign currency translation adjustment, net of tax 64     64  
Net loss (23,749)       (23,749)
Ending balance (in shares) at Mar. 31, 2023   53,653,182      
Ending balance at Mar. 31, 2023 420,021 $ 52 912,291 (7,439) (484,883)
Beginning balance (in shares) at Dec. 31, 2022   53,533,250      
Beginning balance at Dec. 31, 2022 430,911 $ 52 898,806 (7,503) (460,444)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Foreign currency translation adjustment, net of tax (1,167)        
Net loss (72,187)        
Ending balance (in shares) at Sep. 30, 2023   54,153,496      
Ending balance at Sep. 30, 2023 394,134 $ 52 936,954 (8,670) (534,202)
Beginning balance (in shares) at Mar. 31, 2023   53,653,182      
Beginning balance at Mar. 31, 2023 420,021 $ 52 912,291 (7,439) (484,883)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Repurchase and retirement of common stock (in shares)   (12,000)      
Repurchase and retirement of common stock (67)       (67)
RSU settlements, net of shares withheld (in shares)   362,710      
RSU settlements, net of shares withheld (1,508)   (1,508)    
Issuance of common stock for services (in shares)   3,647      
Issuance of common stock for services 36   36    
Issuance of common stock for cash upon exercise of stock options (in shares)   2,930      
Issuance of common stock for cash upon exercise of stock options 6   6    
Issuance of common stock upon exercise of warrants (in shares)   3,132      
Issuance of common stock upon exercise of warrants 26   26    
Employee stock-based compensation expense 12,663   12,663    
Foreign currency translation adjustment, net of tax (1,011)     (1,011)  
Net loss (24,953)       (24,953)
Ending balance (in shares) at Jun. 30, 2023   54,013,601      
Ending balance at Jun. 30, 2023 405,213 $ 52 923,514 (8,450) (509,903)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common stock under employee stock purchase plan (in shares)   143,816      
Issuance of common stock under employee stock purchase plan 1,039   1,039    
Repurchase and retirement of common stock (in shares)   (92,766)      
Repurchase and retirement of common stock (814)       (814)
RSU settlements, net of shares withheld (in shares)   64,879      
RSU settlements, net of shares withheld (355)   (355)    
Issuance of common stock for services (in shares)   4,513      
Issuance of common stock for services 37   37    
Issuance of common stock for cash upon exercise of stock options (in shares)   19,453      
Issuance of common stock for cash upon exercise of stock options 99   99    
Employee stock-based compensation expense 12,620   12,620    
Foreign currency translation adjustment, net of tax (220)     (220)  
Net loss (23,485)       (23,485)
Ending balance (in shares) at Sep. 30, 2023   54,153,496      
Ending balance at Sep. 30, 2023 $ 394,134 $ 52 936,954 (8,670) (534,202)
Beginning balance (in shares) at Dec. 31, 2023 51,503,377 51,503,377      
Beginning balance at Dec. 31, 2023 $ 261,328 $ 49 946,511 (6,963) (678,269)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common stock under employee stock purchase plan (in shares)   73,759      
Issuance of common stock under employee stock purchase plan 532   532    
Repurchase and retirement of common stock (in shares)   (55,500)      
Repurchase and retirement of common stock (522)       (522)
RSU settlements, net of shares withheld (in shares)   252,662      
RSU settlements, net of shares withheld (668)   (668)    
Issuance of common stock for services (in shares)   6,813      
Issuance of common stock for services 56   56    
Issuance of common stock for cash upon exercise of stock options (in shares)   1,501      
Issuance of common stock for cash upon exercise of stock options 8   8    
Employee stock-based compensation expense 13,295   13,295    
Foreign currency translation adjustment, net of tax (1,145)     (1,145)  
Net loss (16,659)       (16,659)
Ending balance (in shares) at Mar. 31, 2024   51,782,612      
Ending balance at Mar. 31, 2024 $ 256,225 $ 49 959,734 (8,108) (695,450)
Beginning balance (in shares) at Dec. 31, 2023 51,503,377 51,503,377      
Beginning balance at Dec. 31, 2023 $ 261,328 $ 49 946,511 (6,963) (678,269)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common stock for cash upon exercise of stock options (in shares) 211,700        
Foreign currency translation adjustment, net of tax $ (216)        
Net loss $ (25,461)        
Ending balance (in shares) at Sep. 30, 2024 53,106,871 53,106,871      
Ending balance at Sep. 30, 2024 $ 273,246 $ 50 984,627 (7,179) (704,252)
Beginning balance (in shares) at Mar. 31, 2024   51,782,612      
Beginning balance at Mar. 31, 2024 256,225 $ 49 959,734 (8,108) (695,450)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
RSU settlements, net of shares withheld (in shares)   811,360      
RSU settlements, net of shares withheld (3,600) $ 1 (3,601)    
Issuance of common stock for services (in shares)   4,935      
Issuance of common stock for services 49   49    
Issuance of common stock for cash upon exercise of stock options (in shares)   18,536      
Issuance of common stock for cash upon exercise of stock options 123   123    
Employee stock-based compensation expense 13,122   13,122    
Foreign currency translation adjustment, net of tax 144     144  
Net loss (1,394)       (1,394)
Ending balance (in shares) at Jun. 30, 2024   52,617,443      
Ending balance at Jun. 30, 2024 264,669 $ 50 969,427 (7,964) (696,844)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Issuance of common stock under employee stock purchase plan (in shares)   85,260      
Issuance of common stock under employee stock purchase plan 865   865    
RSU settlements, net of shares withheld (in shares)   208,508      
RSU settlements, net of shares withheld (2,577)   (2,577)    
Issuance of common stock for services (in shares)   3,997      
Issuance of common stock for services 48   48    
Issuance of common stock for cash upon exercise of stock options (in shares)   191,663      
Issuance of common stock for cash upon exercise of stock options 3,191   3,191    
Employee stock-based compensation expense 13,673   13,673    
Foreign currency translation adjustment, net of tax 785     785  
Net loss $ (7,408)       (7,408)
Ending balance (in shares) at Sep. 30, 2024 53,106,871 53,106,871      
Ending balance at Sep. 30, 2024 $ 273,246 $ 50 $ 984,627 $ (7,179) $ (704,252)
v3.24.3
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Operating activities:    
Net loss $ (25,461) $ (72,187)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:    
Stock-based compensation 40,208 39,125
Depreciation and amortization 10,833 10,755
Asset impairments and write-downs 0 1,000
Amortization of right-of-use assets 4,236 4,020
Unrealized loss on long-term marketable equity securities 0 1,185
Revaluation of contingent consideration to estimated fair value 761 1,731
Loss on disposal of asset 0 37
Gain on settlement of obligation and recovery of written-off investment 0 (2,109)
Amortization of premium and accretion of discount on short-term marketable securities, net 1,177 (3,410)
Revaluation of common stock warrant liability to estimated fair value 0 (10)
Changes in operating assets and liabilities:    
Accounts receivable (15,550) 15,351
Inventory 294 758
Prepaid and other assets (315) 2,542
Operating lease liabilities, net (4,425) (4,088)
Accounts payable (6,699) (990)
Accrued compensation 10,239 (336)
Accrued and other liabilities 804 (3,462)
Change in deferred taxes 57 81
Net cash provided by (used in) operating activities 16,159 (10,007)
Investing activities:    
Acquisitions of business, net of cash acquired 0 (6,682)
Acquisitions of intangible assets 0 (896)
Purchases of short-term marketable securities (143,185) (192,131)
Maturities of short-term marketable securities 149,775 206,503
Purchase of corporate equity securities 0 (965)
Additions of capital expenditures (4,962) (6,750)
Net cash provided by (used in) investing activities 1,628 (921)
Financing activities:    
Proceeds from issuance of common stock under employee stock purchase plan 1,397 1,495
Taxes paid related to net share settlement of restricted stock units (6,525) (2,514)
Proceeds from exercise of warrants 0 4
Proceeds from exercise of stock options 3,322 107
Payment of contingent consideration on acquisitions (2,375) (250)
Repurchase and retirement of common stock (522) (1,571)
Net cash used in financing activities (4,703) (2,729)
Effect of exchange rate changes on cash and cash equivalents 125 (224)
Net increase (decrease) in cash, cash equivalents and restricted cash 13,209 (13,881)
Cash, cash equivalents and restricted cash at beginning of period 82,783 90,443
Cash, cash equivalents and restricted cash at end of period $ 95,992 $ 76,562
v3.24.3
ORGANIZATION AND DESCRIPTION OF BUSINESS
 9 Months Ended
Sep. 30, 2024
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 was 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.
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 $704.3 million at September 30, 2024. As of September 30, 2024, the Company had cash, cash equivalents and marketable securities of $240.9 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”), and thereafter filed post-effective amendments on May 9, 2024 and May 23, 2024. The Securities and Exchange Commission (“SEC”) declared the Registration Statement effective on May 23, 2024, and as a result, 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 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 purchases, one or more Rule 10b5-1 trading plans and block trades and in privately negotiated transactions. During the nine months ended September 30, 2024, the Company purchased an aggregate of 55,500 shares of its common stock under the Repurchase Program for an aggregate purchase price of $0.5 million. There were no repurchases during the three months ended September 30, 2024. As of September 30, 2024, $21.4 million remained available for future share repurchases under the Repurchase Program.
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies and estimates used in the preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2023, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
Use of Estimates
The preparation of unaudited condensed 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 unaudited condensed 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
For the three months ended September 30, 2024 and 2023, approximately 37% and 36%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2024 and 2023, approximately 38% and 41%, respectively, of total revenue was derived from Medicare.
As of September 30, 2024 and December 31, 2023, approximately 27% and 36%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either September 30, 2024 or December 31, 2023.
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 September 30, 2024, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than 12 months at the time of purchase, which were classified as current assets on the condensed consolidated balance sheets.
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, net, on the condensed 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, net. The cost of securities sold is determined using specific identification.
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 condensed consolidated statements of operations.
Leases
The Company 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 condensed consolidated balance sheets 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 September 30, 2024, the Company’s leases had remaining terms of 0.58 years to 8.34 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. These estimates require 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, the Company's discussions with payers, and other pertinent information. In addition, consistent with ASC 606-10-25-1, the Company continues to assess whether it is probable that it will collect substantially all of the consideration to which it will be entitled when determining if a contract with a customer exists.
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 in the contract. The products are delivered and risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement. There are no further performance obligations related to a contract and revenue is recognized at the point of delivery consistent with the terms of the contract or purchase order.
Patient and Digital Solutions Revenue
Patient and digital solutions revenue is primarily 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.
Recent Accounting Pronouncements
There were no recently adopted accounting standards which had a material effect on the Company’s condensed 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 an 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. 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. The Company is currently evaluating the potential effect that the updated standard will have on its financial statement disclosures.
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. The Company is currently evaluating the potential effect that the updated standard will have on its financial statement disclosures.
v3.24.3
NET LOSS PER SHARE
 9 Months Ended
Sep. 30, 2024
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.
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):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Numerator:
Net loss used to compute basic and diluted net loss per share$(7,408)$(23,485)$(25,461)$(72,187)
Denominator:
Weighted-average shares used to compute basic and diluted net loss per share
52,903,338 54,178,759 52,266,106 53,891,374 
Net loss per share:
Basic and diluted$(0.14)$(0.43)$(0.49)$(1.34)
The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2024 and 2023 because their effect would be antidilutive:
Three and Nine Months Ended September 30,
20242023
Outstanding common stock options
3,741,694 3,167,977 
Outstanding restricted stock units
6,418,992 4,977,616 
Total common stock equivalents10,160,686 8,145,593 
v3.24.3
FAIR VALUE MEASUREMENTS
 9 Months Ended
Sep. 30, 2024
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 September 30, 2024 and December 31, 2023 (in thousands):
September 30, 2024
Fair Value Measured Using 
(Level 1)(Level 2)(Level 3)Total Balance
Assets    
Cash equivalents:
Money market funds$50,366 $— $— $50,366 
Total$50,366 $— $— $50,366 
Liabilities
Short-term liabilities:
Contingent consideration$— $— $4,537 $4,537 
Long-term liabilities:
Contingent consideration— — 1,310 1,310 
Total$— $— $5,847 $5,847 
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 
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)
Contingent Consideration
Balance as of December 31, 2023
$7,930 
Change in estimated fair value of contingent consideration on business combination
761 
Change in estimated fair value of contingent consideration on asset acquisition
(469)
Payments related to contingent consideration(2,375)
Balance as of September 30, 2024
$5,847 
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, monitoring and/or 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 condensed 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 in the transaction for $2.5 million. The Company recognized a $1.5 million gain from the disposal of Miromatrix and recorded it as other income (expense), net at December 31, 2023. There was no outstanding investment in Miromatrix as of September 30, 2024.
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 September 30, 2024 and December 31, 2023, money market funds were included as cash and cash equivalents in the condensed 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% to 12% at September 30, 2024 and December 31, 2023. 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 condensed 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 results 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.
v3.24.3
CASH AND MARKETABLE SECURITIES
 9 Months Ended
Sep. 30, 2024
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 condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands):
September 30, 2024September 30, 2023
Cash and cash equivalents$95,400 $75,980 
Restricted cash592 582 
Total cash, cash equivalents and restricted cash at the end of the period
$95,992 $76,562 
Marketable Securities
All short-term marketable securities were considered held-to-maturity at September 30, 2024. At September 30, 2024, 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. The Company assesses whether the decline in value of short-term marketable securities is temporary or other-than-temporary. In making its assessment, the Company evaluates the current market and interest rate environment as well as specific issuer
information. There was no recognition of any other-than-temporary impairment at September 30, 2024. All short-term marketable securities with unrealized losses as of the balance sheet date have been in a loss position for less than 12 months. Contractual maturities of the short-term marketable securities were within one year or less.
The amortized cost, unrealized holding gains, net and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):
September 30, 2024
Amortized Cost
Unrealized Holding Gains, Net
Fair Value
Short-term marketable securities:
U.S. agency securities$90,571 $1,982 $92,553 
Corporate debt securities54,882 499 55,381 
Total short-term marketable securities$145,453 $2,481 $147,934 
December 31, 2023
Amortized Cost
Unrealized Holding Gains, Net
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 securities$153,221 $2,749 $155,970 
v3.24.3
BUSINESS COMBINATIONS AND ASSET ACQUISITION
 9 Months Ended
Sep. 30, 2024
Business Combination, Asset Acquisition, and Joint Venture Formation [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 condensed consolidated statements 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 has been included in the Company’s condensed consolidated statements of operations from the 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 condensed consolidated statements 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 condensed consolidated statements of operations from the respective acquisition date.
Combined Consideration Paid
The following table summarizes the consideration paid for HLA Data Systems (final amount) and MediGO (final amount) of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
Total
Consideration
Cash and contingent consideration
$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 consideration
(1,620)
Other liabilities(7)
Total identifiable net assets acquired4,036 
Goodwill2,646 
Total consideration$6,682 
The 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. Only one asset was acquired and the entire cost is assigned to the licensing agreement, which is recorded under Intangible assets, net, in the condensed consolidated balance sheets. The licensing agreement has an indefinite life and is presented in notes to the unaudited condensed consolidated financial statements under the intangible assets with indefinite lives category.
v3.24.3
GOODWILL AND INTANGIBLE ASSETS
 9 Months Ended
Sep. 30, 2024
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 upon the occurrence of certain events or substantive changes in circumstances. There were no indicators of impairment in the three and nine months ended September 30, 2024. The Company identified an indicator of goodwill impairment in the three and nine months ended September 30, 2023 but determined no impairment. The balance of the Company’s goodwill was $40.3 million as of September 30, 2024 and December 31, 2023.
Intangible Assets
The following table presents details of the Company’s intangible assets as of September 30, 2024 ($ in thousands):
September 30, 2024
Gross Carrying AmountAccumulated AmortizationForeign Currency TranslationNet Carrying AmountWeighted Average Remaining Useful Life
(In Years)
Intangible assets with finite lives:
Acquired and developed technology$37,367 $(20,651)$(2,306)$14,410 6.7
Customer relationships25,718 (10,359)(1,978)13,381 8.5
Commercialization rights11,579 (5,443)— 6,136 4.8
Trademarks and tradenames5,220 (2,000)(293)2,927 8.7
Total intangible assets with finite lives79,884 (38,453)(4,577)36,854 
Intangible assets with indefinite lives:
Acquired in-process technology1,250 — — 1,250 
Favorable license agreement
2,257 — — 2,257 
Total intangible assets with indefinite lives
3,507 — — 3,507 
Total intangible assets$83,391 $(38,453)$(4,577)$40,361 
The following table presents details of the Company’s intangible assets as of December 31, 2023 ($ in thousands):
December 31, 2023
Gross Carrying AmountAccumulated AmortizationForeign Currency TranslationNet Carrying AmountWeighted 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 
Intangible assets with indefinite lives:
Acquired in-process technology1,250 — — 1,250 
Favorable license agreement
2,726 — — 2,726 
Total intangible assets with indefinite lives
3,976 — — 3,976 
Total intangible assets$83,860 $(33,643)$(4,516)$45,701 
Acquisition of Intangible Assets
In January 2023 and July 2023, the Company acquired the intangible assets of HLA Data Systems and MediGO, respectively. The Acquired and developed technology, Customer relationships, and Trademarks and tradenames are recorded under Intangible assets, net, in the condensed consolidated balance sheets as of September 30, 2024 and 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 condensed consolidated statements of operations.
The following table summarizes the Company’s amortization expense of intangible assets (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Cost of testing services$329 $329 $987 $987 
Cost of product419 408 1,250 1,242 
Cost of patient and digital solutions170 265 679 768 
Sales and marketing
634 616 1,895 1,817 
Total$1,552 $1,618 $4,811 $4,814 
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2024 (in thousands):
Years Ending December 31,Cost of Testing ServicesCost of ProductCost of Patient and Digital SolutionsSales and MarketingTotal
Remainder of 2024$329 $429 $170 $638 $1,566 
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 7,601 13,139 
Total future amortization expense$7,102 $6,964 $4,356 $18,432 $36,854 
v3.24.3
BALANCE SHEET COMPONENTS
 9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
BALANCE SHEET COMPONENTS BALANCE SHEET COMPONENTS
Inventory
Inventory consisted of the following (in thousands):
September 30, 2024December 31, 2023
Finished goods$5,435 $3,658 
Work in progress4,202 5,191 
Raw materials9,626 10,622 
Total inventory$19,263 $19,471 
Accrued and Other Liabilities
Accrued and other liabilities consisted of the following (in thousands):
September 30, 2024December 31, 2023
Clinical studies$16,250 $15,744 
Short-term lease liability6,124 5,943 
Deferred revenue5,552 4,748 
Professional fees5,499 5,911 
Contingent consideration4,537 5,469 
Laboratory processing fees and materials 3,293 2,890 
Travel and expenses
684 — 
Accrued shipping expenses399 335 
Deferred payments for intangible assets250 920 
Accrued royalty229 348 
Capital expenditures146 151 
License and other collaboration fees67 250 
Other accrued expenses2,256 2,788 
Total accrued and other liabilities$45,286 $45,497 
v3.24.3
COMMITMENTS AND CONTINGENCIES
 9 Months Ended
Sep. 30, 2024
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 September 30, 2024, the carrying value of the ROU asset was $25.8 million. The related current and non-current liabilities as of September 30, 2024 were $6.1 million and $23.8 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 condensed consolidated balance sheets.
Effective March 2024, the Company entered into a sublease agreement with a sub-lessee (a third-party) for office space with a six-year term, commencing on May 1, 2024, for a total of $2.6 million base rent for the duration of the contract.
The following table summarizes the lease cost for the three and nine months ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Operating lease cost$1,957 $1,981 $5,893 $5,936 
Total lease cost$1,957 $1,981 $5,893 $5,936 
September 30, 2024December 31, 2023
Other information:
Weighted-average remaining lease term - Operating leases (in years)
4.825.43
Weighted-average discount rate - Operating leases (%)
7.1 %7.1 %
Maturities of operating lease liabilities as of September 30, 2024 are as follows (in thousands):
Years Ending December 31,Operating Leases
Remainder of 2024$1,954 
20257,975 
20267,166 
20277,274 
20286,599 
Thereafter4,115 
Total lease payments35,083 
Less imputed interest5,118 
Present value of future minimum lease payments29,965 
Less operating lease liability, current portion6,124 
Operating lease liability, less current portion$23,841 
The following table summarizes the supplemental cash flow information related to leases for the three and nine months ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used for operating leases$1,567 $1,172 $4,396 $3,871 
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 September 30, 2024.
Illumina
On May 4, 2018, the Company entered into a license agreement with Illumina, Inc. (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.
Other Commitments
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
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 condensed consolidated financial statements indicates that it is probable that a liability had been incurred at the date of the condensed consolidated financial statements, and (ii) the range of loss can be reasonably estimated.
Natera Inc.
In response to the Company’s 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. In August 2023, the Court issued an injunction prohibiting Natera from making the claims the jury previously found to be false advertising. Both parties appealed. On October 8, 2024, the United States Court of Appeals for the Third Circuit remanded the case to make additional filings.
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 appealed that decision. On March 13, 2024, the Federal Circuit dismissed Natera's appeal after Natera failed to file its brief and other required papers. On May 30, 2024, Natera filed a second notice of appeal of the dismissal of U.S. Patent 10,597,724. On June 19, 2024, the Company moved to dismiss Natera’s appeal. On September 11, 2024, the Federal Circuit denied that motion.
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. Following trial, the parties engaged in discovery as to whether the Company’s current AlloSure process infringes the Natera's U.S. Patent 11,111,544. On September 11, 2024, Natera informed the Court that it was abandoning claims
of ongoing infringement. Natera has moved for an injunction on the Company’s prior AlloSure process. The Company is opposing the motion. The Company is seeking judicial review of the verdict. Natera is also seeking judicial review of the jury’s finding that the Company did not infringe Natera's U.S. Patent 10,655,180. The Company intends to defend itself in 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 recognized the damages of $96.3 million as other liabilities on the condensed consolidated balance sheets as of September 30, 2024 and December 31, 2023.
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 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.
In a court document unsealed on October 7, 2024, the DOJ notified the United States District Court for the Eastern District of New York that it was declining to intervene in a qui tam action filed against the Company by a former employee that served as the basis for the CID. Accordingly, CareDx understands that the DOJ has closed its investigation of the Company with no finding of wrongdoing. The Company denies the allegations in the qui tam action and intends to vigorously defend itself should the private plaintiff pursue these claims.
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. Although the Company remains committed to compliance with all applicable laws and regulations, it cannot predict the outcome of any other requests or investigations that may arise in the future.
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.
On September 18, 2024, the court granted the Company’s motion to dismiss the second amended complaint without prejudice, providing plaintiffs leave to file a third amended complaint by no later than October 2, 2024 (a deadline which was subsequently extended by stipulation). On October 18, 2024, plaintiffs filed a third amended complaint, which again alleges that the Company and the individual defendants made materially false and/or misleading statements and/or omissions in violation of Section 10(b) of the Exchange Act, and Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act. Among other things, plaintiffs removed former Chief Financial Officer, Ankur Dhingra, as a named defendant. The third amended complaint reiterates many of the same factual allegations as in prior complaints, but purports to add new allegations based on, among other things, a recently unsealed qui tam action filed by a former employee.
Defendants’ motion to dismiss the third amended complaint is due on November 15, 2024. Plaintiffs’ response is due on December 13, 2024, and defendants’ reply is due on January 10, 2025. The hearing on the motion to dismiss has been scheduled for January 28, 2025. 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.
Derivative Actions
On September 21, 2022, Jeffrey Edelman 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 Drs. Seeto and Maag and Mr. Dhingra, and other current and former members of the Company's Board of Directors asserting, among other things, alleged breaches of fiduciary duty against the Individual Defendants based on the factual allegations of the Securities Class Action (the “Edelman Derivative Action”).
On December 8, 2022, the court entered an order staying the Edelman Derivative Action subject to certain terms and conditions.
On February 7, 2023, Jaysen Stevenson 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 Drs. Seeto and Maag and Mr. Dhingra, and other current and former members of the Company’s Board of Directors asserting substantially similar claims (the “Stevenson Derivative Action”).
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.
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 us as nominal defendant and Dr. Seeto, Mr. Dhingra, Dr. Maag, and other current and former members of the Company's Board of Directors asserting substantially similar claims as the prior-filed derivative actions (the “Jacobsen Derivative Action”).
On March 19, 2024, the parties to the Jacobsen Derivative Action and the consolidated Edelman Derivative Action and Stevenson Derivative Action filed a stipulation and proposed order consolidating the Jacobsen Derivative Action with the consolidated Edelman Derivative Action and Stevenson Derivative Action and staying the Jacobsen Derivative Action pursuant to the terms of the stay order in the Edelman Derivative Action. On April 23, 2024, the court entered an order consolidating all three derivative actions (the “Consolidated Derivative Action”). The order provides that all previous orders in the Edelman Derivative Action and the Stevenson Derivative Action shall apply to the Jacobsen Derivative Action.
On May 16, 2024, the court lifted the stay in the Consolidated Derivative Action. Under a scheduling order entered by the court on May 14, 2024, plaintiffs filed an amended complaint in the Consolidated Derivative Action on July 1, 2024. Pursuant to a briefing notice entered by the court on June 17, 2024, defendants filed a motion to dismiss the amended complaint and an unopposed motion to stay discovery in the Consolidated Derivative Action on August 30, 2024. On October 10, 2024, the court held a case management conference to discuss the impact of the Securities Class Action on the Consolidated Derivative Action. On October 17, 2024, the parties submitted a proposed schedule to the court for approval. On October 18, 2024, the court entered a revised schedule. Under the schedule, plaintiffs’ deadline to file a second amended complaint is November 8, 2024, and defendants’ deadline to file an answer or otherwise respond to the second amended complaint is December 13, 2024. Plaintiffs’ opposition papers are due on January 24, 2025 and defendants’ reply is due on February 14, 2025. A hearing on the motion to dismiss and the motion to stay was scheduled for March 4, 2025.
On March 20, 2024, Edward W. Burns IRA filed a stockholder derivative action complaint in the Court of Chancery of the State of Delaware against the Company as nominal defendant and Dr. Seeto, Mr. Dhingra, Dr. Maag, and other current and former members of the Board of Directors (the “Burns Derivative Action”). Prior to filing the complaint, the Company produced documents to the plaintiff in response to a books and records inspection demand made pursuant to Section 220 of the Delaware General Corporation Law. The plaintiff purports to incorporate those documents in the complaint. The plaintiff alleges that the individual defendants breached their fiduciary duties as directors and/or officers of the Company and engaged in insider trading, unjust enrichment, waste of corporate assets, and aiding and abetting breaches of fiduciary duty. The suit seeks declaratory relief, recovery of alleged damages sustained by the Company as a result of the alleged violations, equitable relief, restitution, and plaintiff’s costs incurred in the lawsuit, including reasonable attorneys’, accountants’, and experts’ fees, costs, and expenses. On April 11, 2024, the court entered an order staying the Burns Derivative Action pursuant to a stipulation filed by the parties.
On May 30, 2024, the parties to the Burns Derivative Action filed an amended stipulation and proposed order to continue the stay in that action, which was so-ordered by the court on May 31, 2024.
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.
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.
On May 17, 2024, the Superior Court entered a decision finding against the Company. The Company has filed a notice of appeal.
v3.24.3
401(K) PLAN
 9 Months Ended
Sep. 30, 2024
Retirement Benefits [Abstract]  
401(K) PLAN 401(K) PLAN
The Company sponsors a 401(k) defined contribution plan (the “401(k) Plan”) covering all U.S. employees under the Internal Revenue Code of 1986, as amended. Employee contributions to the 401(k) Plan 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 401(k) Plan of $0.0 million and $0.2 million for the three months ended September 30, 2024 and 2023, respectively. The Company incurred expenses related to contributions to the 401(k) Plan of $2.1 million and $1.4 million for the nine months ended September 30, 2024 and 2023, respectively.
v3.24.3
WARRANTS
 9 Months Ended
Sep. 30, 2024
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. Warrant liabilities are remeasured at fair value at each period end with changes in fair value recorded in the condensed 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.
As of September 30, 2024 and December 31, 2023, no warrants to purchase common stock were outstanding.
v3.24.3
STOCK INCENTIVE PLANS
 9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
STOCK INCENTIVE PLANS STOCK INCENTIVE PLANS
Stock Options and Restricted Stock Units (“RSU”)
The following table summarizes option and RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan, 2019 Inducement Equity Incentive Plan, 2024 Equity Incentive Plan and Employment Inducement
Grants, 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, 2023869,111 3,055,208 $25.21 5,006,775 $19.02 
Additional shares authorized7,047,461 — — — — 
Common stock awards for services(15,745)— — — — 
RSUs granted(3,583,116)— — 3,583,116 10.56 
RSUs vested— — — (1,767,773)18.20 
Options granted(1,031,037)1,031,037 12.73 — — 
Options exercised— (211,700)15.69 — — 
Repurchase of common stock under employee incentive plans494,310 — — — — 
RSUs forfeited403,126 — — (403,126)15.42 
Options forfeited24,637 (24,637)28.47 — — 
Options expired108,214 (108,214)31.98 — — 
Balance—September 30, 20244,316,961 3,741,694 $22.09 6,418,992 $14.93 
The total intrinsic value of options exercised was $2.8 million and $2.9 million for the three and nine months ended September 30, 2024, respectively. The total intrinsic value of options exercised was $0.1 million for each of the three and nine months ended September 30, 2023, respectively.
As of September 30, 2024, the total intrinsic value of outstanding RSUs was approximately $205.7 million and there were $53.1 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 2.07 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 412,843 and 449,983 as of September 30, 2024 and December 31, 2023, respectively. The weighted-average remaining recognition period was 0.34 years and 1.01 years as of September 30, 2024 and December 31, 2023, respectively.
Options outstanding that have vested and are expected to vest at September 30, 2024 are as follows:
Number of Shares Issued
(In thousands)		Weighted-Average
Exercise Price		Weighted-Average Remaining Contractual Life (Years)Aggregate Intrinsic Value
(In thousands)
Vested2,048 $25.70 6.19$18,616 
Expected to vest1,502 17.89 8.7221,481 
Total3,550 $40,097 

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 September 30, 2024 for stock options that were in-the-money.
The total fair value of options that vested during the three and nine months ended September 30, 2024 was $2.4 million and $8.8 million, respectively. As of September 30, 2024, there were approximately $17.3 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 2.68 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 respective 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 2024 that ended on June 30, 2024, 85,260 shares were purchased pursuant to the ESPP for aggregate proceeds of $0.9 million from the issuance of such shares, which occurred on July 2, 2024.
During the offering period in 2023 that ended on December 31, 2023, 73,759 shares were purchased pursuant to the ESPP for aggregate proceeds of $0.5 million from the issuance of such shares, which occurred on January 2, 2024. 
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:
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Employee stock options
Expected term (in years)6.0N/A5.95.6
Expected volatility78.20%N/A76.80%77.86%
Risk-free interest rate3.52%N/A4.39%3.67%
Expected dividend yield—%N/A—%—%
Employee stock purchase plan
Expected term (in years)0.50.50.50.5
Expected volatility91.99%93.38%91.99%93.38%
Risk-free interest rate5.37%5.53%5.28%5.49%
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.
Volatility: The 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 non-employee stock-based awards for the three and nine months ended September 30, 2024 and 2023, included in the condensed consolidated statements of operations as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Cost of testing services$418 $496 $1,232 $1,467 
Cost of product234 301 776 935 
Cost of patient and digital solutions326 297 1,048 1,066 
Research and development1,775 1,491 5,163 5,157 
Sales and marketing2,786 3,041 8,757 9,557 
General and administrative8,155 7,045 23,232 20,943 
Total$13,694 $12,671 $40,208 $39,125 
No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets. In addition, no amounts of stock-based compensation expense were capitalized for the periods presented.
v3.24.3
INCOME TAXES
 9 Months Ended
Sep. 30, 2024
Income Tax Disclosure [Abstract]  
INCOME TAXES INCOME TAXES
The Company's effective tax rate may vary from the U.S. federal statutory tax rate due to a change in valuation allowance, change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits, and the tax impact of non-deductible expenses and other permanent differences between income before income taxes and taxable income.
For the three and nine months ended September 30, 2024, the Company recorded an income tax expense of $0.2 million and $0.1 million, respectively. For the three and nine months ended September 30, 2023, the Company recorded an income tax benefit of $80,000 and $24,000, respectively. The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and negative, including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of future taxable income, and (iv) 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 it is more likely than not that it will not be able to realize its U.S. consolidated net deferred tax assets. The Company has also placed a valuation allowance on the net deferred tax assets of its Sweden operations. Accordingly, the U.S. and Sweden net deferred tax assets have been offset by a full valuation allowance.
v3.24.3
SEGMENT REPORTING
 9 Months Ended
Sep. 30, 2024
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 Chief Operating Decision Maker (“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 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, the region of testing for testing services revenue and the region where the performance obligation is satisfied for patient and digital solutions revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Testing services revenue
United States$60,408 $47,644 $184,757 $162,560 
Rest of World399 140 805 422 
$60,807 $47,784 $185,562 $162,982 
Product revenue
United States$6,850 $5,810 $18,701 $13,857 
Europe2,488 2,437 7,592 7,430 
Rest of World874 1,289 3,123 2,986 
$10,212 $9,536 $29,416 $24,273 
Patient and digital solutions revenue
United States$11,824 $9,735 $32,102 $27,130 
Europe27 34 93 239 
Rest of World13 103 33 131 
$11,864 $9,872 $32,228 $27,500 
Total United States$79,082 $63,189 $235,560 $203,547 
Total Europe$2,515 $2,471 $7,685 $7,669 
Total Rest of World$1,286 $1,532 $3,961 $3,539 
Total$82,883 $67,192 $247,206 $214,755 
The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):
September 30, 2024December 31, 2023
Long-lived assets:
United States$33,670 $34,714 
Europe331 476 
Rest of World14 56 
Total$34,015 $35,246 
v3.24.3
RESTRUCTURING
 9 Months Ended
Sep. 30, 2024
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 affected location was closed as of June 2024. The Company did not incur restructuring charges for the three months ended September 30, 2024 and incurred immaterial charges for the nine months ended September 30, 2024. The Company incurred immaterial restructuring charges for each of the three and nine months ended September 30, 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. The Company did not incur any restructuring charges related to this plan in the three and nine months ended September 30, 2024. The Company incurred $0.0 million and $0.8 million in restructuring charges for the three and nine months ended September 30, 2023, respectively.
v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure                
Net loss $ (7,408) $ (1,394) $ (16,659) $ (23,485) $ (24,953) $ (23,749) $ (25,461) $ (72,187)
v3.24.3
Insider Trading Arrangements
 3 Months Ended 9 Months Ended
Sep. 30, 2024
shares
Sep. 30, 2024
shares
Trading Arrangements, by Individual    
Non-Rule 10b5-1 Arrangement Adopted false  
Rule 10b5-1 Arrangement Terminated false  
Non-Rule 10b5-1 Arrangement Terminated false  
Jeffrey A. Novack [Member]    
Trading Arrangements, by Individual    
Material Terms of Trading Arrangement  
On August 19, 2024, Jeffrey A. Novack, our General Counsel, adopted a trading plan intended to satisfy the conditions under Rule 10b5-1(c) of the Exchange Act. Mr. Novack’s plan is for the sale of up to 32,821 shares of common stock in amounts and prices determined in accordance with a formula set forth in the plan and terminates on the earlier of the date that all the shares under the plan are sold and November 7, 2025, subject to early termination for certain specified events set forth in the plan.
Name Jeffrey A. Novack  
Title General Counsel  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date August 19, 2024  
Expiration Date November 7, 2025  
Arrangement Duration 445 days  
Aggregate Available 32,821 32,821
Peter Maag [Member]    
Trading Arrangements, by Individual    
Material Terms of Trading Arrangement  
On August 21, 2024, Peter Maag, a member of our Board of Directors, adopted a trading plan intended to satisfy the conditions under Rule 10b5-1(c) of the Exchange Act. Mr. Maag’s plan is for the sale of up to 58,281 shares of common stock in amounts and prices determined in accordance with a formula set forth in the plan and terminates on the earlier of the date that all the shares under the plan are sold and November 14, 2025, subject to early termination for certain specified events set forth in the plan.
Name Peter Maag  
Title member of our Board of Directors  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date August 21, 2024  
Expiration Date November 14, 2025  
Arrangement Duration 450 days  
Aggregate Available 58,281 58,281
Alexander Johnson [Member]    
Trading Arrangements, by Individual    
Material Terms of Trading Arrangement  
On August 28, 2024, Alexander Johnson, our then-President of Patient and Testing Services, who has since left the Company, adopted a trading plan intended to satisfy the conditions under Rule 10b5-1(c) of the Exchange Act. Mr. Johnson’s plan is for the sale of up to 164,081 shares of common stock in amounts and prices determined in accordance with a formula set forth in the plan and terminates on the earlier of the date that all the shares under the plan are sold and November 21, 2025, subject to early termination for certain specified events set forth in the plan.
Name Alexander Johnson  
Title President of Patient and Testing Services  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date August 28, 2024  
Expiration Date November 21, 2025  
Arrangement Duration 450 days  
Aggregate Available 164,081 164,081
Abhishek Jain [Member]    
Trading Arrangements, by Individual    
Material Terms of Trading Arrangement  
On September 12, 2024, Abhishek Jain, our Chief Financial Officer, adopted a trading plan intended to satisfy the conditions under Rule 10b5-1(c) of the Exchange Act. Mr. Jain’s plan is for the sale of up to 128,499 shares of common stock in amounts and prices determined in accordance with a formula set forth in the plan and terminates on the earlier of the date that all the shares under the plan are sold and September 30, 2025, subject to early termination for certain specified events set forth in the plan.
Name Abhishek Jain  
Title Chief Financial Officer  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date September 12, 2024  
Expiration Date September 30, 2025  
Arrangement Duration 383 days  
Aggregate Available 128,499 128,499
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
 9 Months Ended
Sep. 30, 2024
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 $704.3 million at September 30, 2024. As of September 30, 2024, the Company had cash, cash equivalents and marketable securities of $240.9 million and no debt outstanding.
Basis of Presentation
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
Use of Estimates
Use of Estimates
The preparation of unaudited condensed 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 unaudited condensed 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
For the three months ended September 30, 2024 and 2023, approximately 37% and 36%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2024 and 2023, approximately 38% and 41%, respectively, of total revenue was derived from Medicare.
As of September 30, 2024 and December 31, 2023, approximately 27% and 36%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either September 30, 2024 or December 31, 2023.
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 September 30, 2024, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than 12 months at the time of purchase, which were classified as current assets on the condensed consolidated balance sheets.
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, net, on the condensed 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, net. The cost of securities sold is determined using specific identification.
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 condensed consolidated statements of operations.
Leases
Leases
The Company 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 condensed consolidated balance sheets 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 September 30, 2024, the Company’s leases had remaining terms of 0.58 years to 8.34 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. These estimates require 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, the Company's discussions with payers, and other pertinent information. In addition, consistent with ASC 606-10-25-1, the Company continues to assess whether it is probable that it will collect substantially all of the consideration to which it will be entitled when determining if a contract with a customer exists.
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 in the contract. The products are delivered and risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement. There are no further performance obligations related to a contract and revenue is recognized at the point of delivery consistent with the terms of the contract or purchase order.
Patient and Digital Solutions Revenue
Patient and digital solutions revenue is primarily 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.
Recent Accounting Pronouncements
Recent Accounting Pronouncements
There were no recently adopted accounting standards which had a material effect on the Company’s condensed 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 an 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. 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. The Company is currently evaluating the potential effect that the updated standard will have on its financial statement disclosures.
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. The Company is currently evaluating the potential effect that the updated standard will have on its financial statement disclosures.
v3.24.3
NET LOSS PER SHARE (Tables)
 9 Months Ended
Sep. 30, 2024
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):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Numerator:
Net loss used to compute basic and diluted net loss per share$(7,408)$(23,485)$(25,461)$(72,187)
Denominator:
Weighted-average shares used to compute basic and diluted net loss per share
52,903,338 54,178,759 52,266,106 53,891,374 
Net loss per share:
Basic and diluted$(0.14)$(0.43)$(0.49)$(1.34)
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 as of September 30, 2024 and 2023 because their effect would be antidilutive:
Three and Nine Months Ended September 30,
20242023
Outstanding common stock options
3,741,694 3,167,977 
Outstanding restricted stock units
6,418,992 4,977,616 
Total common stock equivalents10,160,686 8,145,593 
v3.24.3
FAIR VALUE MEASUREMENTS (Tables)
 9 Months Ended
Sep. 30, 2024
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 September 30, 2024 and December 31, 2023 (in thousands):
September 30, 2024
Fair Value Measured Using 
(Level 1)(Level 2)(Level 3)Total Balance
Assets    
Cash equivalents:
Money market funds$50,366 $— $— $50,366 
Total$50,366 $— $— $50,366 
Liabilities
Short-term liabilities:
Contingent consideration$— $— $4,537 $4,537 
Long-term liabilities:
Contingent consideration— — 1,310 1,310 
Total$— $— $5,847 $5,847 
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 
Summary of Issuances, Exercises, 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)
Contingent Consideration
Balance as of December 31, 2023
$7,930 
Change in estimated fair value of contingent consideration on business combination
761 
Change in estimated fair value of contingent consideration on asset acquisition
(469)
Payments related to contingent consideration(2,375)
Balance as of September 30, 2024
$5,847 
v3.24.3
CASH AND MARKETABLE SECURITIES (Tables)
 9 Months Ended
Sep. 30, 2024
Cash and Cash Equivalents [Abstract]  
Summary of Reconciliation of Cash and Cash Equivalents
A reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands):
September 30, 2024September 30, 2023
Cash and cash equivalents$95,400 $75,980 
Restricted cash592 582 
Total cash, cash equivalents and restricted cash at the end of the period
$95,992 $76,562 
Summary of Marketable Securities
The amortized cost, unrealized holding gains, net and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):
September 30, 2024
Amortized Cost
Unrealized Holding Gains, Net
Fair Value
Short-term marketable securities:
U.S. agency securities$90,571 $1,982 $92,553 
Corporate debt securities54,882 499 55,381 
Total short-term marketable securities$145,453 $2,481 $147,934 
December 31, 2023
Amortized Cost
Unrealized Holding Gains, Net
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 securities$153,221 $2,749 $155,970 
v3.24.3
BUSINESS COMBINATIONS AND ASSET ACQUISITION (Tables)
 9 Months Ended
Sep. 30, 2024
Business Combination, Asset Acquisition, and Joint Venture Formation [Abstract]  
Summary of Identified Intangible Assets Acquired at Acquisition Date
The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ 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 (final amount) and MediGO (final amount) of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
Total
Consideration
Cash and contingent consideration
$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 consideration
(1,620)
Other liabilities(7)
Total identifiable net assets acquired4,036 
Goodwill2,646 
Total consideration$6,682 
v3.24.3
GOODWILL AND INTANGIBLE ASSETS (Tables)
 9 Months Ended
Sep. 30, 2024
Goodwill and Intangible Assets Disclosure [Abstract]  
Summary of Intangible Assets
The following table presents details of the Company’s intangible assets as of September 30, 2024 ($ in thousands):
September 30, 2024
Gross Carrying AmountAccumulated AmortizationForeign Currency TranslationNet Carrying AmountWeighted Average Remaining Useful Life
(In Years)
Intangible assets with finite lives:
Acquired and developed technology$37,367 $(20,651)$(2,306)$14,410 6.7
Customer relationships25,718 (10,359)(1,978)13,381 8.5
Commercialization rights11,579 (5,443)— 6,136 4.8
Trademarks and tradenames5,220 (2,000)(293)2,927 8.7
Total intangible assets with finite lives79,884 (38,453)(4,577)36,854 
Intangible assets with indefinite lives:
Acquired in-process technology1,250 — — 1,250 
Favorable license agreement
2,257 — — 2,257 
Total intangible assets with indefinite lives
3,507 — — 3,507 
Total intangible assets$83,391 $(38,453)$(4,577)$40,361 
The following table presents details of the Company’s intangible assets as of December 31, 2023 ($ in thousands):
December 31, 2023
Gross Carrying AmountAccumulated AmortizationForeign Currency TranslationNet Carrying AmountWeighted 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 
Intangible assets with indefinite lives:
Acquired in-process technology1,250 — — 1,250 
Favorable license agreement
2,726 — — 2,726 
Total intangible assets with indefinite lives
3,976 — — 3,976 
Total intangible assets$83,860 $(33,643)$(4,516)$45,701 
Summary of Finite-Lived Intangible Assets Amortization Expense
The following table summarizes the Company’s amortization expense of intangible assets (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Cost of testing services$329 $329 $987 $987 
Cost of product419 408 1,250 1,242 
Cost of patient and digital solutions170 265 679 768 
Sales and marketing
634 616 1,895 1,817 
Total$1,552 $1,618 $4,811 $4,814 
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 September 30, 2024 (in thousands):
Years Ending December 31,Cost of Testing ServicesCost of ProductCost of Patient and Digital SolutionsSales and MarketingTotal
Remainder of 2024$329 $429 $170 $638 $1,566 
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 7,601 13,139 
Total future amortization expense$7,102 $6,964 $4,356 $18,432 $36,854 
v3.24.3
BALANCE SHEET COMPONENTS (Tables)
 9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Summary of Inventory
Inventory consisted of the following (in thousands):
September 30, 2024December 31, 2023
Finished goods$5,435 $3,658 
Work in progress4,202 5,191 
Raw materials9,626 10,622 
Total inventory$19,263 $19,471 
Summary of Components of Accrued and Other Liabilities
Accrued and other liabilities consisted of the following (in thousands):
September 30, 2024December 31, 2023
Clinical studies$16,250 $15,744 
Short-term lease liability6,124 5,943 
Deferred revenue5,552 4,748 
Professional fees5,499 5,911 
Contingent consideration4,537 5,469 
Laboratory processing fees and materials 3,293 2,890 
Travel and expenses
684 — 
Accrued shipping expenses399 335 
Deferred payments for intangible assets250 920 
Accrued royalty229 348 
Capital expenditures146 151 
License and other collaboration fees67 250 
Other accrued expenses2,256 2,788 
Total accrued and other liabilities$45,286 $45,497 
v3.24.3
COMMITMENTS AND CONTINGENCIES (Tables)
 9 Months Ended
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
Summary of Lease Cost
The following table summarizes the lease cost for the three and nine months ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Operating lease cost$1,957 $1,981 $5,893 $5,936 
Total lease cost$1,957 $1,981 $5,893 $5,936 
September 30, 2024December 31, 2023
Other information:
Weighted-average remaining lease term - Operating leases (in years)
4.825.43
Weighted-average discount rate - Operating leases (%)
7.1 %7.1 %
The following table summarizes the supplemental cash flow information related to leases for the three and nine months ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows used for operating leases$1,567 $1,172 $4,396 $3,871 
Summary of Future Minimum Lease Commitments under Operating and Finance Leases
Maturities of operating lease liabilities as of September 30, 2024 are as follows (in thousands):
Years Ending December 31,Operating Leases
Remainder of 2024$1,954 
20257,975 
20267,166 
20277,274 
20286,599 
Thereafter4,115 
Total lease payments35,083 
Less imputed interest5,118 
Present value of future minimum lease payments29,965 
Less operating lease liability, current portion6,124 
Operating lease liability, less current portion$23,841 
v3.24.3
STOCK INCENTIVE PLANS (Tables)
 9 Months Ended
Sep. 30, 2024
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 RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan, 2019 Inducement Equity Incentive Plan, 2024 Equity Incentive Plan and Employment Inducement
Grants, 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, 2023869,111 3,055,208 $25.21 5,006,775 $19.02 
Additional shares authorized7,047,461 — — — — 
Common stock awards for services(15,745)— — — — 
RSUs granted(3,583,116)— — 3,583,116 10.56 
RSUs vested— — — (1,767,773)18.20 
Options granted(1,031,037)1,031,037 12.73 — — 
Options exercised— (211,700)15.69 — — 
Repurchase of common stock under employee incentive plans494,310 — — — — 
RSUs forfeited403,126 — — (403,126)15.42 
Options forfeited24,637 (24,637)28.47 — — 
Options expired108,214 (108,214)31.98 — — 
Balance—September 30, 20244,316,961 3,741,694 $22.09 6,418,992 $14.93 
Summary of Options Outstanding and Exercisable Vested or Expected to Vest
Options outstanding that have vested and are expected to vest at September 30, 2024 are as follows:
Number of Shares Issued
(In thousands)		Weighted-Average
Exercise Price		Weighted-Average Remaining Contractual Life (Years)Aggregate Intrinsic Value
(In thousands)
Vested2,048 $25.70 6.19$18,616 
Expected to vest1,502 17.89 8.7221,481 
Total3,550 $40,097 
Summary of Weighted-Average Assumptions Used to Estimate Fair Values 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:
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Employee stock options
Expected term (in years)6.0N/A5.95.6
Expected volatility78.20%N/A76.80%77.86%
Risk-free interest rate3.52%N/A4.39%3.67%
Expected dividend yield—%N/A—%—%
Employee stock purchase plan
Expected term (in years)0.50.50.50.5
Expected volatility91.99%93.38%91.99%93.38%
Risk-free interest rate5.37%5.53%5.28%5.49%
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 non-employee stock-based awards for the three and nine months ended September 30, 2024 and 2023, included in the condensed consolidated statements of operations as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Cost of testing services$418 $496 $1,232 $1,467 
Cost of product234 301 776 935 
Cost of patient and digital solutions326 297 1,048 1,066 
Research and development1,775 1,491 5,163 5,157 
Sales and marketing2,786 3,041 8,757 9,557 
General and administrative8,155 7,045 23,232 20,943 
Total$13,694 $12,671 $40,208 $39,125 
v3.24.3
SEGMENT REPORTING (Tables)
 9 Months Ended
Sep. 30, 2024
Segment Reporting [Abstract]  
Summary of Reportable Revenues by Geographic Regions The following table summarizes reportable revenues by geographic regions (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Testing services revenue
United States$60,408 $47,644 $184,757 $162,560 
Rest of World399 140 805 422 
$60,807 $47,784 $185,562 $162,982 
Product revenue
United States$6,850 $5,810 $18,701 $13,857 
Europe2,488 2,437 7,592 7,430 
Rest of World874 1,289 3,123 2,986 
$10,212 $9,536 $29,416 $24,273 
Patient and digital solutions revenue
United States$11,824 $9,735 $32,102 $27,130 
Europe27 34 93 239 
Rest of World13 103 33 131 
$11,864 $9,872 $32,228 $27,500 
Total United States$79,082 $63,189 $235,560 $203,547 
Total Europe$2,515 $2,471 $7,685 $7,669 
Total Rest of World$1,286 $1,532 $3,961 $3,539 
Total$82,883 $67,192 $247,206 $214,755 
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):
September 30, 2024December 31, 2023
Long-lived assets:
United States$33,670 $34,714 
Europe331 476 
Rest of World14 56 
Total$34,015 $35,246 
v3.24.3
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details)
 3 Months Ended 9 Months Ended 23 Months Ended
May 09, 2023
USD ($)
Apr. 01, 2023
USD ($)
Dec. 08, 2022
Sep. 30, 2024
USD ($)
shares
Sep. 30, 2024
USD ($)
solution
shares
Sep. 30, 2023
USD ($)
Mar. 31, 2023
USD ($)
May 23, 2024
shares
Dec. 31, 2023
USD ($)
Dec. 03, 2022
USD ($)
Jan. 31, 2018
patient
Schedule of Capitalization, Equity [Line Items]                      
Payments to acquire minority interest         $ 0 $ 965,000          
Number of renal transplant patients (more than) | patient                     1,900
Accumulated deficit       $ 704,252,000 704,252,000       $ 678,269,000    
Cash, cash equivalents, and marketable securities       240,900,000 240,900,000            
Debt outstanding       $ 0 $ 0            
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                
Number of common stock purchased (in shares) | shares       0 55,500            
Stock repurchased value         $ 500,000            
Stock repurchase program, remaining authorized repurchase amount       $ 21,400,000 $ 21,400,000            
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                  
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Credit Risk (Details) - Medicare
 3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Revenue Benchmark | Customer Concentration Risk          
Concentration Risk [Line Items]          
Concentration risk percentage 37.00% 36.00% 38.00% 41.00%  
Accounts Receivable | Credit Concentration Risk          
Concentration Risk [Line Items]          
Concentration risk percentage     27.00%   36.00%
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Leases (Details)
 9 Months Ended
Sep. 30, 2024
Minimum  
Summary Of Significant Accounting Policies [Line Items]  
Remaining lease terms (in years) 6 months 29 days
Maximum  
Summary Of Significant Accounting Policies [Line Items]  
Remaining lease terms (in years) 8 years 4 months 2 days
v3.24.3
NET LOSS PER SHARE - Summary of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Numerator:        
Net loss used to compute basic net loss per share $ (7,408) $ (23,485) $ (25,461) $ (72,187)
Net loss used to compute diluted net loss per share $ (7,408) $ (23,485) $ (25,461) $ (72,187)
Denominator:        
Weighted-average shares used to compute basic net loss per share (in shares) 52,903,338 54,178,759 52,266,106 53,891,374
Weighted-average shares used to compute diluted net loss per share (in shares) 52,903,338 54,178,759 52,266,106 53,891,374
Net loss per share:        
Basic (in dollars per share) $ (0.14) $ (0.43) $ (0.49) $ (1.34)
Diluted (in dollars per share) $ (0.14) $ (0.43) $ (0.49) $ (1.34)
v3.24.3
NET LOSS PER SHARE - Summary of Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (Details) - shares
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Potentially dilutive securities excluded from calculation of diluted net loss per share (in shares) 10,160,686 8,145,593 10,160,686 8,145,593
Outstanding common stock options        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Potentially dilutive securities excluded from calculation of diluted net loss per share (in shares) 3,741,694 3,167,977 3,741,694 3,167,977
Outstanding restricted stock units        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Potentially dilutive securities excluded from calculation of diluted net loss per share (in shares) 6,418,992 4,977,616 6,418,992 4,977,616
v3.24.3
FAIR VALUE MEASUREMENTS - Summary of Fair Value of Financial Assets and Liabilities Measured on Recurring Basis (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Short-term liabilities:    
Contingent consideration $ 4,537 $ 5,469
Recurring    
Assets    
Total 50,366 60,525
Short-term liabilities:    
Contingent consideration 4,537 5,469
Long-term liabilities:    
Contingent consideration 1,310 2,461
Total 5,847 7,930
Recurring | Money market funds    
Assets    
Cash equivalents 50,366 60,525
Fair Value Measured Using - (Level 1) | Recurring    
Assets    
Total 50,366 60,525
Short-term liabilities:    
Contingent consideration 0 0
Long-term liabilities:    
Contingent consideration 0 0
Total 0 0
Fair Value Measured Using - (Level 1) | Recurring | Money market funds    
Assets    
Cash equivalents 50,366 60,525
Fair Value Measured Using - (Level 2) | Recurring    
Assets    
Total 0 0
Short-term liabilities:    
Contingent consideration 0 0
Long-term liabilities:    
Contingent consideration 0 0
Total 0 0
Fair Value Measured Using - (Level 2) | Recurring | Money market funds    
Assets    
Cash equivalents 0 0
Fair Value Measured Using - (Level 3) | Recurring    
Assets    
Total 0 0
Short-term liabilities:    
Contingent consideration 4,537 5,469
Long-term liabilities:    
Contingent consideration 1,310 2,461
Total 5,847 7,930
Fair Value Measured Using - (Level 3) | Recurring | Money market funds    
Assets    
Cash equivalents $ 0 $ 0
v3.24.3
FAIR VALUE MEASUREMENTS - Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments (Details)
$ in Thousands
 9 Months Ended
Sep. 30, 2024
USD ($)
Contingent Consideration  
Beginning balance $ 7,930
Ending balance 5,847
Contingent Consideration on business combination  
Contingent Consideration  
Change in estimated fair value of common stock warrant liability and contingent consideration 761
Payments related to contingent consideration (2,375)
Contingent Consideration on asset acquisition  
Contingent Consideration  
Change in estimated fair value of common stock warrant liability and contingent consideration $ (469)
v3.24.3
FAIR VALUE MEASUREMENTS - Additional Information (Details)
$ in Thousands
 1 Months Ended 9 Months Ended 12 Months Ended
Dec. 31, 2023
USD ($)
Mar. 31, 2023
USD ($)
Sep. 30, 2024
USD ($)
Dec. 31, 2023
USD ($)
Fair Value Measurement Inputs and Valuation Techniques [Line Items]        
Write-off of investments in convertible preferred shares   $ 1,000    
Minimum        
Fair Value Measurement Inputs and Valuation Techniques [Line Items]        
Contingent consideration, measurement input, discount rate (as percent)     0.06 0.06
Maximum        
Fair Value Measurement Inputs and Valuation Techniques [Line Items]        
Contingent consideration, measurement input, discount rate (as percent)     0.12 0.12
Miromatrix, Inc.        
Fair Value Measurement Inputs and Valuation Techniques [Line Items]        
Proceeds from sale of equity securities $ 2,500      
Gain on disposal       $ 1,500
Investment     $ 0  
v3.24.3
CASH AND MARKETABLE SECURITIES - Summary of Reconciliation of Cash and Cash Equivalents (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Sep. 30, 2023
Dec. 31, 2022
Cash and Cash Equivalents [Abstract]        
Cash and cash equivalents $ 95,400 $ 82,197 $ 75,980  
Restricted cash 592 586 582  
Total cash, cash equivalents and restricted cash at the end of the period $ 95,992 $ 82,783 $ 76,562 $ 90,443
v3.24.3
CASH AND MARKETABLE SECURITIES - Summary of Components of Marketable Securities (Details) - USD ($)
$ in Thousands
 9 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Schedule of Held-to-maturity Securities [Line Items]    
Other than temporary impairment $ 0  
Short-term marketable securities:    
Amortized Cost 145,453 $ 153,221
Unrealized Holding Gains, Net 2,481 2,749
Fair Value 147,934 155,970
U.S. agency securities    
Short-term marketable securities:    
Debt securities, amortized cost 90,571 80,468
Unrealized holding gain 1,982 2,038
Debt securities, fair value 92,553 82,506
Corporate debt securities    
Short-term marketable securities:    
Debt securities, amortized cost 54,882 72,753
Unrealized holding gain 499 711
Debt securities, fair value $ 55,381 $ 73,464
v3.24.3
BUSINESS COMBINATIONS AND ASSET ACQUISITION - Additional Information (Details)
 1 Months Ended
Aug. 09, 2023
USD ($)
Jul. 31, 2023
USD ($)
intangibleAsset
Jan. 31, 2023
USD ($)
intangibleAsset
Sep. 30, 2024
USD ($)
Dec. 31, 2023
USD ($)
Business Acquisition [Line Items]          
Goodwill       $ 40,336,000 $ 40,336,000
Asset acquisition, consideration transferred $ 2,600,000        
Payments to acquire productive assets 1,800,000        
Contingent consideration 500,000        
Transaction cost $ 300,000        
HLA Data Systems          
Business Acquisition [Line Items]          
Fair value of contingent consideration     $ 1,300,000    
Acquisition related costs     400,000    
Goodwill     2,100,000    
Goodwill expected to be deductible for income tax purposes     $ 0    
Number of intangible assets | intangibleAsset     3    
HLA Data Systems | Discount Rate          
Business Acquisition [Line Items]          
Intangible asset, measurement input (percent)     0.24    
HLA Data Systems | Developed technology | Royalty Rate          
Business Acquisition [Line Items]          
Intangible asset, measurement input (percent)     0.10    
HLA Data Systems | Trademarks | Royalty Rate          
Business Acquisition [Line Items]          
Intangible asset, measurement input (percent)     0.02    
MediGO          
Business Acquisition [Line Items]          
Fair value of 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 (percent)   0.25      
Number of intangible assets | intangibleAsset   3      
MediGO | Developed technology | Royalty Rate          
Business Acquisition [Line Items]          
Intangible asset, measurement input (percent)   0.10      
MediGO | Trademarks | Royalty Rate          
Business Acquisition [Line Items]          
Intangible asset, measurement input (percent)   0.02      
v3.24.3
BUSINESS COMBINATIONS AND ASSET ACQUISITION - Summary of Identified Intangible Assets Acquired at Acquisition Date (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Jul. 31, 2023
Jan. 31, 2023
HLA Data Systems        
Business Acquisition [Line Items]        
Estimated Fair Value       $ 4,100
MediGO        
Business Acquisition [Line Items]        
Estimated Fair Value     $ 2,020  
Customer relationships        
Business Acquisition [Line Items]        
Estimated Useful Lives (Years) 8 years 6 months 9 years 2 months 12 days    
Customer relationships | HLA Data Systems        
Business Acquisition [Line Items]        
Estimated Fair Value       $ 3,010
Estimated Useful Lives (Years)       13 years
Customer relationships | MediGO        
Business Acquisition [Line Items]        
Estimated Fair Value     $ 810  
Estimated Useful Lives (Years)     17 years  
Developed technology | HLA Data Systems        
Business Acquisition [Line Items]        
Estimated Fair Value       $ 770
Estimated Useful Lives (Years)       11 years
Developed technology | MediGO        
Business Acquisition [Line Items]        
Estimated Fair Value     $ 850  
Estimated Useful Lives (Years)     12 years  
Trademarks | HLA Data Systems        
Business Acquisition [Line Items]        
Estimated Fair Value       $ 320
Estimated Useful Lives (Years)       17 years
Trademarks | MediGO        
Business Acquisition [Line Items]        
Estimated Fair Value     $ 360  
Estimated Useful Lives (Years)     17 years  
v3.24.3
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
Sep. 30, 2024
Dec. 31, 2023
Business Acquisition [Line Items]      
Goodwill   $ 40,336 $ 40,336
HLA Data Systems And MediGO      
Business Acquisition [Line Items]      
Total consideration $ 6,682    
Current assets 1,413    
Identifiable intangible assets 6,120    
Current liabilities (1,060)    
Other current liabilities (810)    
Contingent consideration (1,620)    
Other liabilities (7)    
Total identifiable net assets acquired 4,036    
Goodwill 2,646    
Total consideration $ 6,682    
v3.24.3
GOODWILL AND INTANGIBLE ASSETS - Additional Information (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2023
Sep. 30, 2023
Sep. 30, 2024
Dec. 31, 2023
Goodwill and Intangible Assets Disclosure [Abstract]        
Goodwill impairment $ 0 $ 0    
Goodwill     $ 40,336 $ 40,336
v3.24.3
GOODWILL AND INTANGIBLE ASSETS - Summary of Intangible Assets (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Intangible assets with finite lives:    
Gross Carrying Amount $ 79,884 $ 79,884
Accumulated Amortization (38,453) (33,643)
Foreign Currency Translation (4,577) (4,516)
Total future amortization expense 36,854 41,725
Intangible assets with indefinite lives    
Net carrying amount 3,507 3,976
Intangible Assets, Net (Excluding Goodwill)    
Total intangible assets - gross carrying amount 83,391 83,860
Total intangible assets, net 40,361 45,701
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 2,257 2,726
Acquired and developed technology    
Intangible assets with finite lives:    
Gross Carrying Amount 37,367 37,367
Accumulated Amortization (20,651) (18,340)
Foreign Currency Translation (2,306) (2,269)
Total future amortization expense $ 14,410 $ 16,758
Weighted Average Remaining Useful Life (In Years) 6 years 8 months 12 days 7 years 2 months 12 days
Customer relationships    
Intangible assets with finite lives:    
Gross Carrying Amount $ 25,718 $ 25,718
Accumulated Amortization (10,359) (9,094)
Foreign Currency Translation (1,978) (1,959)
Total future amortization expense $ 13,381 $ 14,665
Weighted Average Remaining Useful Life (In Years) 8 years 6 months 9 years 2 months 12 days
Commercialization rights    
Intangible assets with finite lives:    
Gross Carrying Amount $ 11,579 $ 11,579
Accumulated Amortization (5,443) (4,496)
Foreign Currency Translation 0 0
Total future amortization expense $ 6,136 $ 7,083
Weighted Average Remaining Useful Life (In Years) 4 years 9 months 18 days 5 years 7 months 6 days
Trademarks and tradenames    
Intangible assets with finite lives:    
Gross Carrying Amount $ 5,220 $ 5,220
Accumulated Amortization (2,000) (1,713)
Foreign Currency Translation (293) (288)
Total future amortization expense $ 2,927 $ 3,219
Weighted Average Remaining Useful Life (In Years) 8 years 8 months 12 days 9 years 3 months 18 days
v3.24.3
GOODWILL AND INTANGIBLE ASSETS - Summary of Finite-Lived Intangible Assets Amortization Expense (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Indefinite-lived Intangible Assets [Line Items]        
Amortization expense of intangible assets $ 1,552 $ 1,618 $ 4,811 $ 4,814
Cost of Testing Services        
Indefinite-lived Intangible Assets [Line Items]        
Amortization expense of intangible assets 329 329 987 987
Cost of Product        
Indefinite-lived Intangible Assets [Line Items]        
Amortization expense of intangible assets 419 408 1,250 1,242
Cost of Patient and Digital Solutions        
Indefinite-lived Intangible Assets [Line Items]        
Amortization expense of intangible assets 170 265 679 768
Sales and marketing        
Indefinite-lived Intangible Assets [Line Items]        
Amortization expense of intangible assets $ 634 $ 616 $ 1,895 $ 1,817
v3.24.3
GOODWILL AND INTANGIBLE ASSETS - Summary of Estimated Future Amortization Expense of Intangible Assets with Finite Lives (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
Remainder of 2024 $ 1,566  
2025 6,269  
2026 5,302  
2027 5,289  
2028 5,289  
Thereafter 13,139  
Total future amortization expense 36,854 $ 41,725
Cost of Testing Services    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
Remainder of 2024 329  
2025 1,316  
2026 1,316  
2027 1,316  
2028 1,316  
Thereafter 1,509  
Total future amortization expense 7,102  
Cost of Product    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
Remainder of 2024 429  
2025 1,715  
2026 751  
2027 751  
2028 751  
Thereafter 2,567  
Total future amortization expense 6,964  
Cost of Patient and Digital Solutions    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
Remainder of 2024 170  
2025 681  
2026 681  
2027 681  
2028 681  
Thereafter 1,462  
Total future amortization expense 4,356  
Sales and Marketing    
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract]    
Remainder of 2024 638  
2025 2,557  
2026 2,554  
2027 2,541  
2028 2,541  
Thereafter 7,601  
Total future amortization expense $ 18,432  
v3.24.3
BALANCE SHEET COMPONENTS - Summary of Inventory (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Finished goods $ 5,435 $ 3,658
Work in progress 4,202 5,191
Raw materials 9,626 10,622
Total inventory $ 19,263 $ 19,471
v3.24.3
BALANCE SHEET COMPONENTS - Summary Components of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Clinical studies $ 16,250 $ 15,744
Short-term lease liability 6,124 5,943
Deferred revenue 5,552 4,748
Professional fees 5,499 5,911
Contingent consideration 4,537 5,469
Laboratory processing fees and materials 3,293 2,890
Travel and expenses 684 0
Accrued shipping expenses 399 335
Deferred payments for intangible assets 250 920
Accrued royalty 229 348
Capital expenditures 146 151
License and other collaboration fees 67 250
Other accrued expenses 2,256 2,788
Accrued and other liabilities $ 45,286 $ 45,497
v3.24.3
COMMITMENTS AND CONTINGENCIES - Additional Information (Details)
 1 Months Ended
Jan. 26, 2024
USD ($)
May 13, 2022
complaint
Mar. 14, 2022
USD ($)
Dec. 31, 2023
USD ($)
Jul. 31, 2023
Dec. 31, 2022
USD ($)
Jun. 30, 2014
milestone_payment
Sep. 30, 2024
USD ($)
Mar. 31, 2024
USD ($)
Loss Contingencies [Line Items]                  
Operating leases right-of-use assets       $ 29,891,000       $ 25,823,000  
Short-term lease liability       5,943,000       6,124,000  
Operating lease liability, less current portion       $ 28,278,000       $ 23,841,000  
Operating lease, liability, current, statement of financial position [Extensible Enumeration]               Accrued and other liabilities  
Lessee, operating lease, term of contract (in years)                 6 years
Sublease income                 $ 2,600,000
Insurance matter           $ 15,000,000      
Stanford License Royalty Commitment                  
Loss Contingencies [Line Items]                  
Number of milestone payments | milestone_payment             6    
Period after termination (in days)       90 days          
Outstanding obligation               $ 0  
iBox License and Collaboration Agreement                  
Loss Contingencies [Line Items]                  
License period (in years)         4 years        
CAREDX, INC. vs Natera Inc.                  
Loss Contingencies [Line Items]                  
Damages awarded     $ 44,900,000            
Number of claims field | complaint   2              
Loss contingency, damages awarded, value $ 96,300,000                
Accrual for loss contingency       $ 96,300,000       96,300,000  
CAREDX, INC. vs Natera Inc. | Compensatory Damages                  
Loss Contingencies [Line Items]                  
Damages awarded     21,200,000            
CAREDX, INC. vs Natera Inc. | Punitive Damages                  
Loss Contingencies [Line Items]                  
Damages awarded     $ 23,700,000            
Derivative Actions                  
Loss Contingencies [Line Items]                  
Accrual for loss contingency               $ 0  
v3.24.3
COMMITMENTS AND CONTINGENCIES - Summary of Lease Cost (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]        
Operating lease cost $ 1,957 $ 1,981 $ 5,893 $ 5,936
Total lease cost $ 1,957 $ 1,981 $ 5,893 $ 5,936
v3.24.3
COMMITMENTS AND CONTINGENCIES - Summary of Other Information Related to Lease (Details)
Sep. 30, 2024
Dec. 31, 2023
Other information:    
Weighted-average remaining lease term - Operating leases (in years) 4 years 9 months 25 days 5 years 5 months 4 days
Weighted-average discount rate - Operating leases (%) 7.10% 7.10%
v3.24.3
COMMITMENTS AND CONTINGENCIES - Schedule of Future Minimum Lease Commitments under Operating and Finance Leases (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Operating Leases    
Remainder of 2024 $ 1,954  
2025 7,975  
2026 7,166  
2027 7,274  
2028 6,599  
Thereafter 4,115  
Total lease payments 35,083  
Less imputed interest 5,118  
Present value of future minimum lease payments 29,965  
Less operating lease liability, current portion 6,124 $ 5,943
Operating lease liability, less current portion $ 23,841 $ 28,278
v3.24.3
COMMITMENTS AND CONTINGENCIES - Summarizes the Noncash Information (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]        
Operating cash flows used for operating leases $ 1,567 $ 1,172 $ 4,396 $ 3,871
v3.24.3
401(K) PLAN (Details) - USD ($)
$ in Millions
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Retirement Benefits [Abstract]        
Defined benefit plan, type     Postemployment Retirement Benefits [Member]  
Expenses incurred related to 401(k) Plan contributions $ 0.0 $ 0.2 $ 2.1 $ 1.4
v3.24.3
WARRANTS (Details) - shares
Sep. 30, 2024
Dec. 31, 2023
Warrants and Rights Note Disclosure [Abstract]    
Number of warrants outstanding (in shares) 0 0
v3.24.3
STOCK INCENTIVE PLANS - Summary of Option, Unvested RSU Activity under 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and Related Information (Details)
 9 Months Ended
Sep. 30, 2024
$ / shares
shares
Shares Available for Grant  
Shares available for grant beginning balance (in shares) 869,111
Additional options authorized (in shares) 7,047,461
Common stock awards for services (in shares) (15,745)
RSUs granted (in shares) (3,583,116)
Options granted (in shares) (1,031,037)
Repurchase of common stock under employee incentive plans (in shares) 494,310
RSUs forfeited (in shares) 403,126
Options forfeited (in shares) 24,637
Options expired (in shares) 108,214
Shares available for grant ending balance (in shares) 4,316,961
Stock Options Outstanding  
Stock options outstanding beginning balance (in shares) 3,055,208
Stock options granted (in shares) 1,031,037
Stock options exercised (in shares) (211,700)
Stock options forfeited (in shares) (24,637)
Stock options expired (in shares) (108,214)
Stock options outstanding ending balance (in shares) 3,741,694
Weighted- Average Exercise Price  
Weighted average exercise price beginning balance (in dollars per share) | $ / shares $ 25.21
Weighted average exercise price - options granted (in dollars per share) | $ / shares 12.73
Weighted average exercise price - options exercised (in dollars per share) | $ / shares 15.69
Weighted average exercise price - options forfeited (in dollars per share) | $ / shares 28.47
Weighted average exercise price - options expired (in dollars per share) | $ / shares 31.98
Weighted average exercise price ending balance (in dollars per share) | $ / shares $ 22.09
Number of RSU Shares  
RSUs granted (in shares) 3,583,116
RSUs forfeited (in shares) (403,126)
Restricted Stock Units  
Shares Available for Grant  
RSUs granted (in shares) (3,583,116)
RSUs forfeited (in shares) 403,126
Number of RSU Shares  
Number of RSU shares beginning balance (in shares) 5,006,775
RSUs granted (in shares) 3,583,116
RSUs vested (in shares) (1,767,773)
RSUs forfeited (in shares) (403,126)
Number of RSU shares ending balance (in shares) 6,418,992
Weighted- Average Grant Date Fair Value  
Weighted average grant date fair value beginning balance (in dollars per share) | $ / shares $ 19.02
Weighted average grant date fair value - RSUs granted (in dollars per share) | $ / shares 10.56
Weighted average grant date fair value - RSUs vested (in dollars per share) | $ / shares 18.20
Weighted average grant date fair value - RSUs forfeited (in dollars per share) | $ / shares 15.42
Weighted average grant date fair value ending balance (in dollars per share) | $ / shares $ 14.93
v3.24.3
STOCK INCENTIVE PLANS - Additional Information (Details) - USD ($)
 3 Months Ended 9 Months Ended 12 Months Ended
Jul. 02, 2024
Jan. 02, 2024
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Total intrinsic value of options exercised     $ 2,800,000 $ 100,000 $ 2,900,000 $ 100,000  
Proceeds from stock plans         1,397,000 $ 1,495,000  
Share-based compensation expense tax benefit recognized         0    
Share-based compensation expense capitalized         $ 0    
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 (in percent)     15.00%   15.00%    
Maximum value of shares which an employee can purchase per calendar year         $ 25,000    
Offering period for employee stock purchases (in months)         6 months    
Applicable exercise date an offering period shall be equal to percentage of the lower of fair market value of common stock (in percent)         85.00%    
Shares issued under ESPP (in shares) 85,260 73,759          
Proceeds from stock plans $ 900,000 $ 500,000          
Restricted Stock Units              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Intrinsic value of RSUs     $ 205,700,000   $ 205,700,000    
Total unrecognized compensation costs related to stock options and RSUs     $ 53,100,000   $ 53,100,000    
Stock options and RSUs expected weighted average period (in years)         2 years 25 days    
Number of shares outstanding (in shares)     6,418,992   6,418,992   5,006,775
Performance Shares              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock options and RSUs expected weighted average period (in years)         4 months 2 days   1 year 3 days
Vesting period (in years)         2 years    
Number of shares outstanding (in shares)     412,843   412,843   449,983
Employee Stock Option              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Total unrecognized compensation costs related to stock options and RSUs     $ 17,300,000   $ 17,300,000    
Stock options and RSUs expected weighted average period (in years)         2 years 8 months 4 days    
Total fair value of options vested during period     $ 2,400,000   $ 8,800,000    
v3.24.3
STOCK INCENTIVE PLANS - Summary of Options Outstanding Vested and Expected to Vest (Details)
$ / shares in Units, $ in Thousands
 9 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Share-Based Payment Arrangement [Abstract]  
Vested (in shares) | shares 2,048
Expected to vest (in shares) | shares 1,502
Total (in shares) | shares 3,550
Vested (in dollars per share) | $ / shares $ 25.70
Expected to vest (in dollars per share) | $ / shares $ 17.89
Vested, weighted-average remaining contractual life (years) 6 years 2 months 8 days
Expected to vest, weighted-average remaining contractual life (years) 8 years 8 months 19 days
Vested, aggregate intrinsic value | $ $ 18,616
Expected to vest, aggregate intrinsic value | $ 21,481
Total, aggregate intrinsic value | $ $ 40,097
v3.24.3
STOCK INCENTIVE PLANS - Summary of Weighted-Average Assumptions Used to Estimated Fair Values of Share-Based Awards (Details)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
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 6 months
Expected volatility 91.99% 93.38% 91.99% 93.38%
Risk-free interest rate 5.37% 5.53% 5.28% 5.49%
Expected dividend yield 0.00% 0.00% 0.00% 0.00%
Employee stock options        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Expected term (in years) 6 years   5 years 10 months 24 days 5 years 7 months 6 days
Expected volatility 78.20%   76.80% 77.86%
Risk-free interest rate 3.52%   4.39% 3.67%
Expected dividend yield 0.00%   0.00% 0.00%
v3.24.3
STOCK INCENTIVE PLANS - Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense $ 13,694 $ 12,671 $ 40,208 $ 39,125
Cost of testing services        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense 418 496 1,232 1,467
Cost of product        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense 234 301 776 935
Cost of patient and digital solutions        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense 326 297 1,048 1,066
Research and development        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense 1,775 1,491 5,163 5,157
Sales and marketing        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense 2,786 3,041 8,757 9,557
General and administrative        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Share based compensation expense $ 8,155 $ 7,045 $ 23,232 $ 20,943
v3.24.3
INCOME TAXES (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Income Tax Disclosure [Abstract]        
Income tax expense (benefit) $ 200 $ (80) $ 139 $ (24)
v3.24.3
SEGMENT REPORTING - Summary of Reportable Revenues by Geographic Regions (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Segment Reporting Information [Line Items]        
Total revenue $ 82,883 $ 67,192 $ 247,206 $ 214,755
United States        
Segment Reporting Information [Line Items]        
Total revenue 79,082 63,189 235,560 203,547
Europe        
Segment Reporting Information [Line Items]        
Total revenue 2,515 2,471 7,685 7,669
Rest of World        
Segment Reporting Information [Line Items]        
Total revenue 1,286 1,532 3,961 3,539
Testing services revenue        
Segment Reporting Information [Line Items]        
Total revenue 60,807 47,784 185,562 162,982
Testing services revenue | United States        
Segment Reporting Information [Line Items]        
Total revenue 60,408 47,644 184,757 162,560
Testing services revenue | Rest of World        
Segment Reporting Information [Line Items]        
Total revenue 399 140 805 422
Product revenue        
Segment Reporting Information [Line Items]        
Total revenue 10,212 9,536 29,416 24,273
Product revenue | United States        
Segment Reporting Information [Line Items]        
Total revenue 6,850 5,810 18,701 13,857
Product revenue | Europe        
Segment Reporting Information [Line Items]        
Total revenue 2,488 2,437 7,592 7,430
Product revenue | Rest of World        
Segment Reporting Information [Line Items]        
Total revenue 874 1,289 3,123 2,986
Patient and digital solutions revenue        
Segment Reporting Information [Line Items]        
Total revenue 11,864 9,872 32,228 27,500
Patient and digital solutions revenue | United States        
Segment Reporting Information [Line Items]        
Total revenue 11,824 9,735 32,102 27,130
Patient and digital solutions revenue | Europe        
Segment Reporting Information [Line Items]        
Total revenue 27 34 93 239
Patient and digital solutions revenue | Rest of World        
Segment Reporting Information [Line Items]        
Total revenue $ 13 $ 103 $ 33 $ 131
v3.24.3
SEGMENT REPORTING - Summary of Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Segment Reporting Information [Line Items]    
Long-lived assets $ 34,015 $ 35,246
United States    
Segment Reporting Information [Line Items]    
Long-lived assets 33,670 34,714
Europe    
Segment Reporting Information [Line Items]    
Long-lived assets 331 476
Rest of World    
Segment Reporting Information [Line Items]    
Long-lived assets $ 14 $ 56
v3.24.3
RESTRUCTURING (Details)
 1 Months Ended 3 Months Ended 9 Months Ended
Jan. 31, 2023
location
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Restructuring Cost and Reserve [Line Items]          
Restructuring costs   $ 0 $ 0 $ 68,000 $ 848,000
Discontinuation of operations          
Restructuring Cost and Reserve [Line Items]          
Restructuring costs   0      
Employee Severance          
Restructuring Cost and Reserve [Line Items]          
Restructuring costs   $ 0 $ 0 $ 0 $ 800,000
Fremantle, Australia          
Restructuring Cost and Reserve [Line Items]          
Number of locations expected to be discontinued under the restructuring plan | location 1        
Number of locations in Fremantle, Australia | location 2