CareDx : 2025 Annual Report

Published: 2026-04-30 20:06:43 ET CDNA

Published on 04/30/2026 at 08:06 pm EDT

Washington, D.C. 20549

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2025 OR

For the transition period from to

Commission File Number 001-36536

(Exact Name of Registrant as Specified in its Charter)

Delaware 94-3316839

(State or Other Jurisdiction of Incorporation or Organization)

8000 Marina Boulevard

Brisbane, California 94005

(I.R.S. Employer Identification Number)

(Address of Principal Executive Offices, Including Zip Code)

(415) 287-2300

(Registrant's Telephone Number, Including Area Code)

Securities Registered Pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on Which Registered

Common Stock, par value $0.001 per share

CDNA

The Nasdaq Stock Market LLC

Securities Registered Pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act:

Large accelerated filer

☒

Accelerated filer

☐

Non-accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

If securities are registered pursuant to Section 12(b) of the Exchange Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b) of the Exchange Act. ☐

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of a share of the registrant's common stock on June 30, 2025, the last business day of the registrant's most recently completed second fiscal quarter, as reported by the Nasdaq Global Market on such date was approximately $1.0 billion. Shares of the registrant's common stock held by each executive officer, director and holder of 10% or more of the outstanding common stock have been excluded in that such persons may be deemed to be affiliates. This calculation does not reflect a determination that certain persons are affiliates of the registrant for any other purpose.

The number of shares of the registrant's Common Stock outstanding as of February 19, 2026 was 51,216,344.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant's Proxy Statement relating to the 2026 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such Proxy Statement, or an amendment to this Annual Report on Form 10-K, will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant's fiscal year ended December 31, 2025.

‌Item No.

TABLE OF CONTENTS

Page No.

PART I 6

Item 1. Business 6

Item 1A. Risk Factors 21

Item 1B. Unresolved Staff Comments 57

Item 1C. Cybersecurity 57

Item 2. Properties 58

Item 3. Legal Proceedings 58

Item 4. Mine Safety Disclosures 58

PART II 59

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 59

Item 6. [Reserved] 60

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 61

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 72

Item 8. Financial Statements and Supplementary Data 73

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 109

Item 9A. Controls and Procedures 109

Item 9B. Other Information 111

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 111

PART III 112

Item 10. Directors, Executive Officers and Corporate Governance 112

Item 11. Executive Compensation 112

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 112

Item 13. Certain Relationships and Related Transactions, and Director Independence 112

Item 14. Principal Accountant Fees and Services 112

PART IV 113

Item 15. Exhibits and Financial Statement Schedules 113

Item 16. Form 10-K Summary 117

Signatures 118

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements contained in this Annual Report on Form 10-K other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "target," "predict," "expect" and the negative and plural forms of these words and similar expressions are intended to identify forward-looking statements.

"CareDx" or the "Company" or "we" or "us" and "our" as used in this Annual Report on Form 10-K refer to CareDx, Inc. and its subsidiaries.

These forward-looking statements may include, but are not limited to, statements concerning the following:

our ability to generate revenue and increase the commercial success of our current and future testing services, products and patient and digital solutions;

our ability to obtain, maintain and expand reimbursement coverage from payers for our current and other future testing services, if any;

our plans and ability to continue updating our testing services, products and patient and digital solutions to maintain our leading position in transplantation;

the outcome or success of our clinical trial collaborations and registry studies;

the favorable review of our testing services and product offerings, and our future solutions, if any, in peer-reviewed publications;

our ability to obtain additional financing on terms favorable to us, or at all;

our anticipated cash needs and our anticipated uses of our funds, including our estimates regarding operating expenses and capital requirements;

anticipated trends and challenges in our business and the markets in which we operate;

our dependence on certain of our suppliers, service providers and other distribution partners;

disruptions to our business, including disruptions at our laboratories and manufacturing facilities;

our ability to retain key members of our management team;

our ability to make successful acquisitions or investments and to manage the integration of such acquisitions or investments;

our ability to expand internationally;

our compliance with federal, state and foreign regulatory requirements;

our ability to protect and enforce our intellectual property rights, our strategies regarding filing additional patent applications to strengthen our intellectual property rights, and our ability to defend against intellectual property claims that may be brought against us; and

our ability to successfully assert, defend against or settle any litigation brought by or against us or other legal matters or disputes.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled "Risk Factors" included in Part I, Item 1A and elsewhere in this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially and adversely from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements.

Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.

You should read this Annual Report on Form 10-K and the documents that we reference in this Annual Report on Form 10-K and have filed with the Securities and Exchange Commission, or the SEC, as exhibits to this Annual Report on Form 10-K with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. We qualify all forward-looking statements by these cautionary statements.

‌PART I

‌ITEM 1. BUSINESS

Company Overview

CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. We deliver solutions designed to empower clinicians and improve patient outcomes. The Company's integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. Our headquarters is located in Brisbane, California, and we have other primary operations in Omaha, Nebraska and Stockholm, Sweden.

We were originally incorporated in Delaware in December 1998 under the name Hippocratic Engineering, Inc. In April 1999, we changed our name to BioCardia, Inc., and in June 2002, we changed our name to Expression Diagnostics, Inc. In July 2007, we changed our name to XDx, Inc. and in March 2014, we changed our name to CareDx, Inc. Our principal executive offices are located at 8000 Marina Boulevard, Brisbane, California and our telephone number is (415) 287-2300. As of December 31, 2025, substantially all of our revenues came from the United States and Europe, and substantially all of our assets and operations were located in the United States and Sweden.

We are organized and operate as a single reportable segment. Refer to Note 13, Segment Reporting, of the consolidated financial statements included elsewhere in this Annual Report on Form 10-K.

Our Differentiated Approach

We aim to create life-changing solutions that enable transplant patients to thrive. Over the past 25 years, we have made considerable investments, bringing to market a portfolio of solutions that have significantly impacted the lives of hundreds of thousands of transplant patients globally.

At CareDx, we are incredibly passionate about the care of transplant patients and are deeply connected to this market, the patients we help, and the clinicians we serve. However, we still have a tremendous opportunity to unlock growth and innovation by driving greater value for transplant patients, clinicians, our employees, and shareholders.

CareDx is differentiated in the molecular diagnostics market because we innovated the go-to-market model for a laboratory developed test (LDT) business. Many LDT genomic products, like other medical technologies, fail to achieve a significant rate of adoption because clinicians use the products selectively. The cost of switching to a new diagnostic provider is low for clinicians, making it difficult for molecular diagnostic companies to grow in competitive markets. That market dynamic makes the cost of revenue acquisition high, which, coupled with high research and development spend on new products, makes the pursuit of profitability challenging. In fact, very few LDT laboratory companies have reached cash flow break even or become profitable enterprises.

In contrast, we are taking the approach of serving a concentrated market of transplant centers with a portfolio of solutions to improve health outcomes. We believe solutions selling into the same transplant center increases the adoption and adherence to our diagnostic products and allows us to lower our revenue acquisition costs over time. As we launch new products, we can cross-sell them to the same center, gaining leverage on our commercial channel. We also deeply understand the operational needs of these organizations. Our teams across the country provide staff augmentation services inside transplant centers, helping them operate efficiently. Additionally, through our digital business, we generate multiple terabytes of data on how transplant centers operate, which we expect will drive the next wave of innovation for the company by enabling us to build new products and solutions to help transplant centers operate more efficiently, do more transplants, and grow profitably.

We believe that this combination - remaining focused on a concentrated number of transplant centers, lowering our cost of revenue acquisition by cross-selling more solutions into the same institutions, and gaining leverage on our commercial channel - forms a clear and differentiated formula for profitable growth in the molecular diagnostics market. This is how CareDx intends to differentiate itself from other molecular diagnostic companies and competitors in the field.

Our Growth Strategy

CareDx has four strategic priorities: (1) accelerate profitable growth; (2) drive operational excellence; (3) define TRANSPLANT+ and expand our total addressable market; and (4) elevate performance culture.

We plan to accelerate profitable growth by first focusing on solutions-selling at transplant centers, with the goal of increasing the acquisition of new patients and improving patient adherence to our testing protocols. Second, we intend to fully integrate

our digital and patient solutions and laboratory products teams into a single go-to-market model designed to deliver comprehensive solutions that drive loyalty and maximize customer value. Third, we intend to focus on generating clinical evidence to gain optimal payer coverage and reimbursement for our products leading to revenue per test (RPT) appreciation. Finally, we intend to execute on our existing research and development pipeline, with the goal of generating incremental revenues from both in-line and new products that provide solutions to unmet medical needs in transplantation.

A key objective of our growth strategy is to drive operational excellence, including scaling our organization efficiently while delivering a superior customer experience. We believe that operational excellence is critical to achieving profitable growth and margin expansion. This approach includes continual process improvement and strategic investments in enterprise applications, remote process automation, artificial intelligence, and business intelligence tools, along with investments in data security, privacy and secure communications with our patients, providers and payer community.

There are many adjacencies to our core solid organ transplant business that we could enter to grow our total addressable market. We collectively refer to these opportunities as a key strategic initiative called TRANSPLANT+.

TRANSPLANT+ is an initiative to expand our market by recognizing a broader definition of transplant that we believe unlocks significant long-term growth potential. By focusing on this initiative, we aim to pave the way to develop novel solutions that lie at the intersection of transplantation and immunology. We believe leveraging our core scientific and technological expertise in organ transplantation will enable an expansion into adjacent markets, such as pre- and peri-transplant areas of organ assessment, precursor disease areas that often lead to organ failure (such as autoimmune disorders, renal, hepatic, cardiovascular and lung diseases, and hematologic disorders), and cancer or other medical conditions that could require cell therapy or bone marrow transplant.

We recognize that our people are the driving force behind our success, and we cannot unlock our full growth potential without engaging and inspiring the employees that deliver value to our patients and customers.

Our Products and Services

Our commercially available post-transplant testing services consist of AlloSure® Kidney, a donor-derived cell-free DNA, or dd-cfDNA, solution for kidney transplant patients, AlloMap® Heart, a gene expression profiling 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. We have initiated several clinical studies to generate data on our existing and planned future testing

services. From time to time, we partner with pharma and biopharma companies to use our technology and tests, often in clinical trials, to identify or screen for patients that may be appropriate candidates for their products. We also offer high-quality products in the pre-transplant space that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Additionally, we provide digital transplant solutions and various offerings that help transplant centers with workflow and list management, outcomes quality and patient medication adhearance. Our software solutions are currently used in over 170 transplant centers in the U.S.

We also offer specialized pharmacy services for transplant patients. The pharmacy helps patients and caregivers access lifesaving medications by managing complex medication regimens, addressing side effects, and navigating the billing process.

Testing Services

We develop and provide diagnostic testing services for solid organ transplant recipients, hematopoietic stem cell transplant recipients and recipients of cell therapies. During 2025, we performed approximately 200,000 commercial tests from our Brisbane, California laboratory.

The care of organ transplant recipients is an intense and costly effort and requires life-long surveillance and management by highly specialized clinicians and other healthcare providers. Unsuccessful management of organ rejection can result in an additional transplant or worse, death of the patient.

The historical standard for transplant surveillance has been through functional tests and with invasive biopsies to identify histopathological signs of rejection. Both types of testing had (and have) significant limitations:

Functional tests are recognized to be late indicators. Rejection is well known to occur even in the absence of clinical signs or symptoms and damage may occur before organ function is impacted to the extent it is measurable by a functional test; and

Biopsies are invasive and risk damage to the organ and infection from exposure to a medical setting for the procedure itself. They also present risk of mechanical problems, pain, and anxiety to the patient. These risks present an impediment to the usage of biopsies on a routine basis. In addition, biopsies may be difficult to access for patients in more rural settings distant from a transplant center where the procedure would be performed. Importantly, diagnostic precision of biopsies is limited by sampling issues and interobserver variability. Finally, the interpretation of a biopsy relies on descriptive, empirically driven consensus classifications that change over time and frequently lack an etiologic basis.

There is a growing body of evidence that traditional tools do not fully address the dynamic nature of transplant and that rejection begins before clinical signs and symptoms can be observed. Molecular rejection is an active, dynamic process and AlloSure and AlloMap provide clinicians with early indicators of injury, as well as information to risk stratify patients and prognostic insights beyond traditional tools used for surveillance like serum creatnine and Donor-Specific Antibodies (DSA).

Improved post-transplant diagnostics are necessary to achieve further gains in the long-term care and health outcomes of heart, kidney and other organ transplant recipients. More effective solutions for the surveillance and risk assessment of recipients would improve the clinician's ability to individualize immunosuppression therapy and to detect and treat rejection earlier when the treatment is most effective.

Our first product launched in 2005, AlloMap Heart is an innovative gene expression profiling test that is intended to aid clinicians in identification of heart transplant recipients with stable graft function who have a low probability of moderate-to-severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment.

We believe the use of AlloMap Heart, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a heart transplant, can improve patient care by helping healthcare providers avoid the use of unnecessary invasive surveillance biopsies, and may help to determine the appropriate dosage levels of immunosuppressants by measuring activity of the immune system. AlloMap Heart has 510(k) clearance from the U.S. Food and Drug Administration for marketing and sales as a test in heart transplant recipients who have stable graft function at the time of testing, to aid in the identification of those who have a low probability of moderate/severe acute cellular rejection at the time of testing, in conjunction with standard clinical assessment.

AlloSure Heart, our donor-derived cell-free DNA (dd-cfDNA) heart transplant solution, is a molecular diagnostic test intended for the early detection of heart allograft injury and rejection. AlloSure Heart helps provide peace-of-mind that injury is unlikely when dd-cfDNA levels are low. AlloSure Heart is validated to detect all types of clinical rejection, including antibody mediated rejection (AMR) and acute cellular mediated rejection (ACR).

AlloSure Heart was developed specifically for transplant patients and is a non-invasive blood test that analyzes Single Nucleotide Polymorphisms (SNPs) selected across all 22 somatic chromosomes to detect DNA released from a patient's heart allograft, known as dd-cfDNA.

A 2025 Surveillance HeartCare Outcomes Registry (SHORE) analysis published in JACC stated that heart failure established the largest prospective dataset on antibody-mediated rejection in heart transplantation and validated AlloSure Heart as a highly specific biomarker for AMR, enabling more precise, context-driven clinical decision-making.

HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA technology of AlloSure Heart in one surveillance solution. An approach to surveillance using HeartCare provides information from two complementary measures: (i) AlloMap Heart - a measure of immune system status, and (ii) AlloSure Heart - a measure of graft injury. Each HeartCare test provides our proprietary Personalized Risk Report, combining measures of immune activation and graft injury for more precise risk assessment. The intersection of immune activation and graft injury reveals risk strata not seen with either test alone.

HeartCare provides robust information about distinct biological processes, such as immune quiescence, active injury, acute cellular rejection and antibody mediated rejection.

The International Society for Heart and Lung Transplantation, or ISHLT guidelines published online in 2022 reinforced the use of AlloMap Heart and referenced the combined use of AlloSure Heart and AlloMap Heart for surveillance purposes.

The SHORE is a landmark multicenter registry in heart transplant that has monitored over 2,700 transplant patients across 67 transplant centers in the United States since 2018. Our SHORE 3 publication demonstrates that HeartCare helps identify higher-risk patients more precisely than histology or dd-cfDNA alone.

A 2025 SHORE analysis published in the Journal of Heart and Lung Transplantation showed that positive HeartCare results-elevated AlloMap and AlloSure Heart-identified heart transplant recipients at significantly higher risk for graft dysfunction and cardiovascular death, even when biopsy results appeared normal. This analysis showed that patients with AlloMap (+) and AlloSure (+) positive results are approximately 6x more likely to have biopsy-confirmed ACR and approximately 2x more likely to experience poor outcomes than patients with AlloMap (-) and AlloSure (-) negative results.

In 2025, HeartCare expanded its indication to cover pediatric patients of all ages starting at birth.

AlloSure Kidney, our kidney transplant solution, is a molecular diagnostic test intended for the early detection of kidney allograft injury and rejection. AlloSure Kidney is validated to detect all types of clinical rejection including antibody mediated rejection (ABMR) and T-cell mediated rejection (TCMR). As published in Nature Medicine, AlloSure is a robust predictor of severity of rejection, with multiple thresholds enabling more precise risk assessment (low risk of rejection, likely graft injury and high risk of rejection). AlloSure testing is reported as a continuous score, and our relative change value (RCV) compares sequential tests to identify the percentage difference between them; RCV provides further risk stratification for patients whose levels are between 0.5% and 1.0%, and an RCV of ≥ 61% suggests rejection may be occurring.

AlloSure Kidney was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient's kidney allograft, known as dd-cfDNA. AlloSure may identify patients who do not fit the criteria for AMR but may have significant underlying injury, and AlloSure Kidney is currently the only test proven to help identify patients with microvascular inflammation (MVI) who have DSA-negative and C4d-negative. MVI, DSA-negative and C4d-negative, has been recognized as a distinct rejection phenotype according to the Banff 2022 Classification, and is associated with a significant risk of graft failure.

A landmark 2025 study published in the American Journal of Transplantation demonstrated that AlloSure is a clinically actionable tool for kidney transplant surveillance that strongly predicted rejection, improved biopsy yield, and enabled earlier, more precise intervention.

AlloSure Plus is an artificial intelligence-driven diagnostic platform that integrates AlloSure® dd-cfDNA analysis with additional clinical inputs to provide a personalized assessment related to organ rejection risk in transplant recipients. AlloSure Plus is intended to support post-transplant surveillance and clinical evaluation in solid organ transplant patients.

In July 2025, we announced the presentation of multiple independent studies at the 2025 World Transplant Congress evaluating AlloSure Plus across solid organ transplant settings. These presentations included data from an international, prospective study led by the Paris Transplant Group that evaluated AlloSure Plus in renal transplant recipients using biopsy-correlated data.

HistoMap Kidney, our tissue-based molecular solution intended to identify allograft rejection and type of rejection in kidney transplant biopsy tissue. HistoMap Kidney uses gene expression profiling to characterize immune activity and rejection phenotypes, and is designed to complement histopathology by providing molecular information to enhance the clinical interpretation of biopsy results.

Biopsy is the standard of care for kidney transplant patients suspected of rejection, including patients identified through molecular surveillance methods such as AlloSure® Kidney or through clinical signs and symptoms of rejection. HistoMap Kidney is being developed for use on formalin-fixed kidney biopsy tissue to support rejection identification and typing, which may assist clinicians in clinical decision-making and therapy selection.

In 2023, a HistoMap validation study was published in the journal Laboratory Investigation, demonstrating its ability to accurately identify rejection and type as antibody mediated rejection, cellular rejection, mixed rejection, or no rejection.

AlloSure Lung, our solution for lung transplant patients, is a leading indicator of injury and early rejection identification. AlloSure Lung may help guide physicians as to whether bronchoscopy and biopsy may be necessary. AlloSure Lung helps provide peace-of-mind that injury is unlikely when dd-cfDNA levels are low.

In April 2022, a multicenter study of 175 patients published in the Journal of Heart and Lung Transplantation demonstrated that AlloSure Lung reduced surveillance bronchoscopies by 82%, and that AlloSure Lung can identify subclinical acute lung allograft dysfunction in stable patients without clinical signs and symptoms.

AlloSure Lung was developed specifically for transplant patients and is a non-invasive blood test that analyzes SNPs selected across all 22 somatic chromosomes to detect DNA released from a patient's lung allograft, known as dd-cfDNA.

AlloHeme™ is a minimally-invasive, next-generation sequencing (NGS)-based, and artificial intelligence-powered monitoring test designed to predict relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) following allogeneic hematopoietic cell transplant (HCT). AlloHeme is intended to enable the detection of emerging relapse signals earlier than traditional bone marrow-based or marker-specific methods through a universal, ultra-sensitive, blood-based surveillance approach.

The Assessing Chimerism and Relapse of Bone Marrow/HCT Transplant Using AlloHeme Testing (ACROBAT) study (NCT04635384) is a prospective, multi-center, observational trial conducted across U.S. transplant centers to evaluate the clinical performance of AlloHeme in patients following allogeneic HCT. The study generated pivotal clinical validation data presented at the Tandem Meeting in 2025, supporting the potential clinical value of AlloHeme in post-transplant relapse surveillance.

AlloCell, our solution for cell therapy such as CAR-T therapy, monitors the pharmacokinetics of engraftment and persistence of cells for patients who have received allogeneic cell therapy. AlloCell is currently being utilized in research partnerships with biopharma companies developing cell therapies. To date, we have executed multiple agreements with biopharma therapeutics companies to use AlloCell in research and clinical studies.

Laboratory Products

We access global markets through our RUO and CE-marked lab products. We develop, manufacture, market and sell products that increase the chance of successful transplants by facilitating a better match between a solid organ or stem cell donor and a recipient, and help provide post-transplant surveillance. Our laboratory product portfolio includes QTYPE, Olerup SSP and SBT, AlloSeq Tx, AlloSeq HCT, and AlloSeq cfDNA.

A 2025 study published in the American Journal of Transplantation showed that AlloSeq cfDNA delivered highly accurate detection of allograft injury and rejection across multiple organ types, demonstrating strong correlation with biopsy-proven rejection and supporting its use as a reliable, non-invasive surveillance tool.

QTYPE enables Human Leukocyte Antigen, or HLA, typing at a low to intermediate resolution for samples that require a fast turnaround time and uses real-time polymerase chain reaction, or PCR, methodology. QTYPE primarily focuses on typing where rapid typing results are required, such as for deceased donor typing. Typing with QTYPE requires one hour compared to the up to 2-3 hours that it takes to do traditional sequence specific primer, or SSP, typing and the 5-7 hours that it takes with sequence-specific oligonucleotides, or SSO.

Olerup SSP is used to type HLA alleles based on the SSP technology. The Olerup SSP product line comprises products for low to high-resolution HLA typing. The product line includes close to 170 different typing products. We offer one of the most upto-date and comprehensive libraries of HLA typing kits based on SSP technology.

Our distributed NGS products include: AlloSeq Tx, a high-resolution HLA typing solution; AlloSeq cfDNA, our surveillance solution designed to measure dd-cfDNA in blood to detect injury and active rejection in transplant recipients; and AlloSeq HCT, an NGS solution for chimerism testing for stem cell transplant recipients.

AlloSeq Tx is the first of its kind NGS high-resolution HLA typing solution utilizing hybrid capture technology. This technology enables the most comprehensive sequencing, covering more of the HLA genes than other solutions on the market as well as non-HLA genes that may impact transplant patient matching and management. AlloSeq Tx17 received CE mark authorization in May 2020. AlloSeq Tx9 is a high throughput version of AlloSeq Tx17 for HLA typing in high volume laboratories. AlloSeq Tx9 received CE mark authorization in August 2022.

We received CE mark authorization for AlloSeq cfDNA in January 2020. Further clinical uptake for AlloSeq cfDNA will be a result of multiple factors, including product-specific evidence publications, local clinical education, customer laboratory technical proficiency, and levels of country-specific reimbursement.

AlloSeq HCT is an NGS solution for chimerism testing for stem cell transplant recipients. This technology has the potential to provide better sensitivity and data analysis compared to current solutions on the market. AlloSeq HCT received CE mark authorization in May 2022.

Patient and Digital Solutions

We deliver an ecosystem of tailored transplant management solutions designed to help centers grow volume, improve patient outcomes, drive efficiency and ease staff workload through: smarter referral management; personalized patient adherence and monitoring; streamlined operational workflows; quality insights and clinical intelligence; and supporting patients, clinicians, and centers across the entire transplant journey.

Workflow Solutions:

Our Ottr software consists of two unique offerings, Ottr Organ and Ottr Cellular, which provide comprehensive solutions for transplant patient management and enable integration with electronic medical records, or EMR, systems, including Cerner and Epic, providing patient surveillance management tools and outcomes data to transplant centers.

Referral Management:

TxAccess is 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.

Quality Solutions:

Our XynQAPI software simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting, and our XynCare offering 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 2025, we launched an IOTA module, or Increasing Organ Transplant Access, which represents an enhanced XynQAPI and is designed to project the center's performance based on the latest IOTA criteria.

Patient Adherence and Monitoring:

MedActionPlan helps centers address medication adherence challenges that increase graft-loss risk by targeting common barriers with patient-friendly, personalized medication management and education tools to help support better patient adherence.

Our CareDx pharmacy supports patients' medication management with expert transplant pharmacists with specialized knowledge who support patient adherence through dedicated care teams, proactive refill support and personalized, and dosed packaging.

AlloHome is a remote patient monitoring solution designed to drive patient engagement and timely interventions for patients pre- and post-transplant.

Lab Products Solutions:

Our HLA Data Systems software solutions, which include mTilda, VxMatch and VECTR, provide software and interoperability solutions for the histocompatibility and immunogenetics community.

Reimbursement

We have been successful in achieving reimbursement for our testing services.

Medicare

We are reimbursed by Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests. Tests performed on patients covered by Medicare represented 25%, 26% and 27% of all tests in 2025, 2024 and 2023,

respectively. Approximately 46%, 50% and 53% of all testing services revenue was derived from Medicare for the years ended December 31, 2025, 2024 and 2023, respectively.

AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017 through a Local Coverage Determination, or LCD, first issued by Palmetto MolDX, or MolDX, which was formed to identify and establish coverage and reimbursement for molecular diagnostics tests, and then adopted by Noridian Healthcare Solutions, our Medicare Administrative Contractor (MAC), or Noridian. The Medicare reimbursement rate for AlloSure Kidney is $2,753, effective January 1, 2026.

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would have revised the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 16, 2024, the Centers for Medicare and Medicaid Services, or CMS, issued a press release entitled "MolDX Local Coverage Determination Statement," announcing that after careful consideration of the feedback received from interested parties, as well as the public comments and further review of evidence, the MACs decided not to finalize the proposed LCD issued on August 10, 2023. CMS further stated that due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. CMS stated that neither it nor the MACs have changed coverage for the blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances, and explained that transplant patients would continue to have access to these blood tests, including: when there are signs or symptoms of rejection; after a physician-assessed pretest, including for surveillance testing; after an indeterminate biopsy; as a replacement for a biopsy when deemed clinically appropriate by the patient's qualified physician; and for evaluation of the adequacy of immunosuppression.

On December 30, 2024, we received a CPT code (0540U) for our AlloSure tests: AlloSure Kidney, AlloSure Heart and AlloSure Lung, which subjects such tests to a repricing process. In June 2025, we recommended that CMS cross-walk our AlloSure tests to 0493U, another dd-cfDNA test already priced on the Medicare Fee Schedule at $2,753. On November 25, 2025 CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U. The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to the current pricing for AlloSure Heart and AlloSure Lung tests. AlloSure, PLA Code 0540U, was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753.

On July 17, 2025, MolDX and Noridian released a new Proposed Draft foundational LCD (DL40058, DL40060) for Solid Organ Allograft Rejection testing with a revised accompanying billing article (DA60146, DA60152). The Proposed LCD introduced new coverage criteria, utilization limitations, and a new bundled payment concept for certain CareDx testing in a "surveillance" setting, which could lead to fewer surveillance tests being reimbursed. MolDX and Noridian have 365 days from the date of issuance to finalize the Proposed LCD. We cannot predict the ultimate outcome of the LCD process, including as it relates to the Draft LCD, and whether it will produce changes in coverage, reimbursement practices, utilization limitations, or payment amounts, any of which could adversely affect our business, operating results and prospects.

AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for AlloMap Heart is currently $3,240.

AlloSure Heart has been a covered service for Medicare beneficiaries since December 2020. In October 2020, we received a final MolDX Medicare coverage decision for AlloSure Heart. 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 common policy 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 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 for Medicare beneficiaries through the MolDX LCD (Noridian L38629). The Medicare reimbursement rate for HeartCare is $5,993.

Effective May 9, 2023, AlloSure Lung is covered for Medicare beneficiaries through the MolDX LCD (Noridian L38629). The Medicare reimbursement rate for AlloSure Lung is $2,753.

Private Payers and Medicaid Payers

Due to End Stage Renal Disease, or ESRD, regulations by Medicare, most ESRD patients are covered by Medicare and Medicare Advantage plans and have access to AlloSure Kidney. Private payers that have adopted a positive coverage policy include BCBS payers as well as other regional payers. Most Medicaid payers have not yet adopted positive coverage policies for AlloSure Kidney.

AlloSure Heart and AlloSure Lung are covered by Medicare Advantage plans for beneficiaries who meet the coverage criteria. AlloSure Heart and AlloSure Lung are covered by several commercial payers.

We are reimbursed for a substantial portion of the AlloMap Heart tests we perform on patients covered by private payers. Coverage policies approving AlloMap Heart have approached nearly 90% of all covered lives and are published by many of the largest private payers, including Blue Cross Blue Shield, or BCBS payers as well as national payers and by more than half of the state Medicaid agencies in the U.S.

For all tests performed outside the scope of the payer's policy, and for tests performed where the payer has not adopted a coverage policy, we pursue reimbursement on a case-by-case basis. If a reimbursement claim is denied, we generally pursue payment through the particular payer's appeal process.

Testing Services Laboratory Operations

AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung testing is performed in our clinical laboratory, which is located in our Brisbane, California location. Our laboratory holds a certificate of accreditation under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and is accredited by the College of American Pathologists, or CAP. We believe that our laboratory capacity will be adequate to meet demand for AlloSure Kidney, AlloMap Heart and AlloSure Heart, HeartCare and AlloSure Lung and other tests in the development pipeline for the next few years.

There are two types of samples received at the laboratory. When AlloSure Kidney, AlloSure Heart or AlloSure Lung is ordered by a clinician, a blood sample is drawn and sent overnight to our laboratory. When a clinician orders AlloMap Heart, a blood sample is drawn, processed, and then sent via overnight courier to our laboratory. Regardless of the test requested, the test results are typically reported to the ordering clinician within two business days from receipt of the sample. Test samples that fail to meet quality control criteria and have enough remaining material are re-tested on the next available batch of samples, which may extend the turnaround time.

We rely solely on certain suppliers to provide some of the laboratory instruments and key reagents that we use to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung testing. These sole source suppliers include Thermo Fisher Scientific, Inc., or Thermo Fisher, which supplies us with instruments, laboratory reagents and consumables; Roche Molecular Systems, which supplies us with laboratory reagents and consumables; Hamilton Robotics, which supplies equipment and consumables; Illumina, which supplies us with instruments, laboratory reagents and consumables; Becton, Dickinson and Company, and Streck, which supply us with cell preparation tubes; Beckman Coulter, which provides laboratory equipment, reagents and consumables; and Qiagen N.V., which supplies us with a proprietary buffer reagent.

Laboratory Products Manufacturing

We have historically purchased many of the components and raw materials used in our product kits from numerous suppliers worldwide. For reasons of quality assurance, sole source availability or cost effectiveness, certain components and critical raw materials used in the manufacture of our products are available only from one supplier. We have worked closely with our suppliers to develop alternate backup plans to ensure continuity of supply while maintaining high quality and reliability, and in some cases, we have established long-term supply contracts with our suppliers. Due to the high standards and ISO/FDA requirements applicable to the manufacturing of our products, we may not be able to quickly establish additional or replacement sources for certain components or materials.

In the event that we are unable to obtain sufficient quantities of raw materials or components on commercially reasonable terms or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised, which may have a material adverse effect on our business, financial condition and results of operations.

Our manufacturing facility in Stockholm, Sweden is used to support the production, packaging and labeling of our proprietary test kits: Olerup SSP, QTYPE, AlloSeq Tx, AlloSeq cfDNA and HCT. The facility has a certified Quality Management System, or QMS, to the ISO 13485: 2016 standard and country specific MDSAP requirements. This standard includes a special set of requirements specifically related to the supply of medical devices and related services. ISO is an internationally recognized standard for QMS. Recertification is required every three years and we have been successfully recertified since obtaining our original ISO certification. The facility maintains valid EC certificates for compliance to Directive 98/79/EC Annex IV, excluding Sections 4 and 6, Full Quality Assurance System In Vitro Diagnostic Medical Devices and to IVDR (EU) 2017/746 under Annex IX Chapters I and III. Annual surveillance audits are also conducted by the site's notified body to ensure ongoing compliance.

In 2023, we added contract manufacturing in the U.S. and Europe to our global manufacturing capabilities to support our growth.

Additionally, we seek to manufacture to current Good Manufacturing Practice requirements and our QMS is implemented in accordance with FDA Quality System Regulations.

Our manufacturing facility in Fremantle, Australia, was used to support the production, packaging and labeling of our proprietary AlloSeq brand kits. In 2024, we decided to migrate manufacturing from Australia to the U.S. and Europe.

Sales and Marketing

We have organized our commercial sales and marketing teams to be customer-centric in a functional structure that is intended to unlock the potential of our synergistic portfolio of solutions and deliver the best experience for clinicians, patients, and administrators.

In the U.S., the organization and delivery of healthcare, including for transplantation, is highly local. To first and foremost empower local teams to devise effective tactical strategies for selling our solutions into each transplant center, we have created a regional structure. Each region consists of multiple territory account managers responsible for specific transplant centers.

Each region is also supported by the dedicated expertise of individuals that specialize in our digital products, laboratory products, and clinical experts in medical science liaisons.

Outside of the U.S. we similarly have regional structure that includes country managers in Western Europe, and distributors we work with outside of Western Europe to service the needs of our transplant center customers globally.

Competition

With our comprehensive portfolio of surveillance testing services, diagnostic products and patient and digital solutions business offerings, we face different types of competition.

Testing Services

Our competition principally includes clinical reference laboratories and hospital laboratories using existing and routine clinical chemistry tests and biopsies. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera, Inc., or Natera, and Eurofins Transplant Genomics, Inc., or Eurofins, Devyser Diagnostics AB, or Devyser, and Insight Molecular Diagnostics, Inc, or iMDx, have commercially available molecular diagnostics tests.

We expect the competition for post-transplant surveillance to increase as there are several established and early-stage companies in the process of developing products and services for the transplant market that may directly or indirectly compete with AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or our development pipeline. In addition, companies that have not historically focused on transplantation, but have knowledge of dd-cfDNA technology, have indicated they are considering this market.

We believe the principal competitive factors in our target markets include:

quality and strength of clinical and analytical validation data;

confidence in diagnostic results;

technical performance and innovation to deliver new products that provide clinically actionable results;

reputation among customers as a provider of high value transplant diagnostic tests and diagnostic test services;

the extent of reimbursement;

inclusion in practice guidelines;

cost-effectiveness; and

ease of use.

We believe we compete favorably on the factors described above.

Existing diagnostic methods for kidney transplant rejection include general, non-specific clinical chemistry tests, although biopsies are also a surveillance diagnostic tool. Existing diagnostic methods for heart transplant rejection generally involve evaluating biopsy samples to determine the presence or absence of rejection.

These practices have been the standard of care in the United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the various benefits of our tests to change clinical practice. Also, many transplant centers are located within hospitals that have their own laboratory facilities and have capacity to conduct various tests, and some hospitals may choose to rely on internally developed and/or internally performed surveillance and diagnostic tests.

Products

Our competitors within the HLA tissue typing markets comprise a diverse range of manufacturers servicing hospital and commercial reference testing laboratories. The market leader in HLA typing and third-party distributors is Thermo Fisher through its One Lambda business. In certain HLA tissue typing markets that incorporate a wide variety of technology test platforms, such as SSP, SSO and NGS, competitors include: Thermo Fisher, Omixon, GenDx, BAG, Qiagen, and Immucor. We also face competition from hospital and commercial reference laboratories that develop their own in-house testing solutions. We believe that our product line competes favorably with Thermo Fisher as a leading supplier of HLA test kits based on performance, reputation and service.

We expect future competition for post-transplant surveillance kitted solutions for AlloSeq cfDNA and AlloSeq HCT. There are several established and early-stage companies in the process of developing products and services for the transplant market that may directly or indirectly compete with our development pipeline. In addition, companies that have not historically focused on transplantation, but have knowledge of dd-cfDNA technology, have indicated they are considering the transplantation market.

Patient and Digital Solutions

Competition for our digital solutions includes various companies that develop application software and operate in the healthcare field. Our primary competitor for our patient management EMR solution is Phoenix, Epic's transplant application. Our referral application has two known competitors: T-REX and MedSleuth. In addition, other established and emerging healthcare, information technology and service companies may commercialize competitive products, including informatics, analysis, integrated genetic tools and services for health and wellness. Competition for patient pharmacy solutions includes hospital-affiliated pharmacies located on-site at the transplant center and specialty pharmacies that provide transplant-specific care and dispensing services.

Intellectual Property

Patents and Proprietary Technology

To remain competitive, we seek to develop and maintain protection on the proprietary aspects of our technologies. We rely on a combination of patents, copyrights, trademarks, material and data transfer agreements and licenses to protect our intellectual property rights. We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain our competitive position. We generally protect this information with confidentiality agreements and reasonable security measures.

As of December 31, 2025, we had seven U.S. patents related to diagnosing transplant rejection and autoimmune disease, which will expire between August 2027 and May 2035. In addition, we had four U.S. patents related to organ function recovery and allograft preservation, which will expire between July 2038 and June 2041.

We have developed trade secrets and know-how since our inception. These trade secrets and know-how are found particularly in technical areas such as optimized systems for making precise and reproducible q-PCR, measurements, and in the analysis of genomic data and algorithm development.

AlloMap, AlloSure, AlloSeq, AlloCell, AlloHeme, QTYPE, Ottr and CareDx are registered trademarks of ours in the United States.

License Agreements

We may in the future rely, at least in part, upon licensing agreements with third parties to obtain patent rights and transfers of technology, information and know-how that enable us to further our development of additional solutions for post-transplant surveillance. Of the seven existing U.S. patents related to transplant rejection and autoimmunity, four are exclusively licensed.

In May 2018, we entered into a license and commercialization agreement with Illumina, which provides us with worldwide distribution, development and commercialization rights to Illumina's next generation sequencing product line for use in transplantation diagnostic testing. Six issued U.S. patents for HLA genotyping are licensed as part of this agreement.

In April 2020, we entered into a license agreement with Cornell University pursuant to which we were granted exclusive rights to four U.S. patents covering methods and technology for the measurement of gene expression in urine to diagnose kidney transplant rejection.

In June 2021, we entered into a strategic agreement, which was amended in April 2022, with OrganX to develop clinical decision support tools across the transplant patient journey. Together, we and OrganX are developing advanced analytics that integrate AlloSure testing 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.

In March 2023, we entered into a license and collaboration agreement with a private entity pursuant to which we were 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.

Regulation

Our business is subject to and impacted by frequently changing laws and regulations in the United States and internationally. These laws and regulations include regulations particular to our business and laws and regulations relating to conducting business generally (e.g., U.S. Foreign Corrupt Practices Act, Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and similar laws of other jurisdictions). We also are subject to inspections and audits by governmental agencies. Below are certain key regulations applicable to our business.

Clinical Laboratory Improvement Amendments of 1988

Having a clinical laboratory in California, we are required to hold certain federal, state and local licenses, certifications and permits to conduct our business. Under the CLIA, administered by the Centers for Medical and Medicaid Services (CMS), we are required to hold a certificate applicable to the type of work we perform and to comply with standards covering personnel, facilities administration, quality systems, proficiency testing and performance. Most clinical laboratories are subject to regulation under the CLIA, which is designed to ensure that laboratory testing services performed on materials derived from the human body are accurate and reliable.

We have a certificate of accreditation under the CLIA to perform "high complexity" testing. Laboratories performing high complexity testing are required to meet more stringent personnel and quality system requirements than laboratories performing less complex tests. To renew our CLIA certificate, we are subject to inspection every two years to assess compliance with program standards. We were inspected as part of the customary College of American Pathologists audit and recertified in 2024 as a result of passing that inspection. We expect the next regular inspection under the CLIA to occur in 2026.

California Laboratory Licensing

In addition to federal certification requirements of laboratories under the CLIA, licensure is required and maintained for our laboratory under California law. Such laws establish standards for the day-to-day operation of a clinical laboratory, including the training and skills required of personnel and quality control. In addition, California laws mandate proficiency testing, which involves testing of specimens that have been specifically prepared for the laboratory. We are required to maintain compliance with California standards as a condition to continue operation of our laboratory in California.

Other States' Laboratory Testing

Other states require out-of-state laboratories that accept specimens for testing from those states to be licensed. We have obtained licenses in California, Florida, New York, Maryland, Pennsylvania and Rhode Island, and believe we are in compliance with applicable licensing laws.

Food and Drug Administration

The FDA regulates the design, testing, development, manufacture, safety, labeling, marketing, promotion, storage, sale and distribution of medical devices pursuant to its authority under the Federal Food, Drug and Cosmetic Act, or FFDCA. These

regulations apply to all of our products sold in the United States, as well as our facilities in Stockholm, Sweden, used to produce some of our products. The FDA has also asserted that it has the authority to regulate laboratory-developed tests, or LDTs, as medical devices under the FFDCA. An LDT is a test developed by a single laboratory for use only in that laboratory, such as our testing services, AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung.

The FDA has traditionally chosen not to exercise its authority to regulate LDTs because it regulates the primary components in most laboratory-developed tests and because laboratories, such as ours, certified as high complexity under the CLIA are regulated and reviewed by CMS to ensure that laboratory expertise and test procedures and correct analyses are followed.

In April 2025, the U.S. District Court for the Eastern District of Texas vacated the FDA's 2024 final rule under which the FDA intended to provide greater oversight of LDTs. In connection with this, the FDA proposed a rule that would amend its regulations to classify vitro diagnostic products as "medical devices" under the Federal Food, Drug and Cosmetic Act. The Court found that the FDA's authority to promulgate rules over "medical devices" does not extend to "laboratory services." In September 2025, the FDA issued a final rule reverting the text of the regulation as it existed prior to this change limiting the FDA's authority over our testing services.

Health Insurance Portability and Accountability Act

Under the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, collectively, HIPAA, the U.S. Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health information, or PHI, and standardize data content, codes and formats used in healthcare transactions and the standardized identifiers used by healthcare providers, such as us, and health plans.

We have developed policies and procedures in view of these regulations. The requirements under these regulations may change periodically and could have an effect on our business operations if compliance becomes substantially more costly than under current requirements, business practices change or a significant breach to PHI occurs.

In addition to federal privacy regulations, there are a number of state laws governing the confidentiality of health information that are applicable to our operations. New laws governing privacy may be adopted in the future as well. We have taken steps intended to address health information privacy requirements to which we are aware that we are subject.

Whether regulators may find our policies, procedures and other privacy initiatives to be compliant with HIPAA is subject to the regulator's assessment.

Federal and State Self-Referral Prohibitions

We are subject to the federal self-referral prohibitions, commonly known as the Stark Law, and to similar state restrictions such as California's Physician Ownership and Referral Act, or PORA. Where applicable, these restrictions generally prohibit us from billing patients or certain governmental or private payers for clinical laboratory testing services when the physician ordering the test, or any member of such physician's immediate family, has an investment interest in, or compensation arrangement with, us, unless the arrangement meets an exception to the prohibition.

Both the Stark Law and PORA contain exceptions for compensation paid to a physician for personal services rendered by the physician, provided that certain conditions are satisfied. We have compensation arrangements with a number of physicians for personal services, such as speaking engagements and clinical advisory boards. We have structured these arrangements with terms intended to address the requirements of the applicable exceptions to the Stark Law, PORA and other similar state laws. However, we cannot be certain that regulators would find these arrangements to be in compliance with the Stark Law, PORA or similar state laws.

Further, a violation of PORA is a misdemeanor and could result in civil penalties and criminal fines. Finally, other states have self-referral restrictions with which we have to comply that differ from those imposed by federal and California law.

Federal and State Fraud, Abuse and Privacy Laws

Because of the significant federal funding involved in Medicare and Medicaid, Congress and the states have enacted, and actively enforce, a number of laws to eliminate fraud and abuse in federal healthcare programs and across the healthcare system. Our business is subject to compliance with these laws.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Affordability Reconciliation Act, or collectively, the Affordable Care Act, was enacted in the United States. The Affordable Care Act expands the government's investigative and enforcement authority and increases the penalties for fraud and abuse, including amendments to both the Anti-Kickback Statute and the False Claims Act, to make it easier to bring a suit under these statutes. The Affordable Care Act also allocates additional resources and tools for the government to police healthcare fraud, with

expanded subpoena power for HHS, additional funding to investigate fraud and abuse across the healthcare system and expanded use of recovery audit contractors for enforcement.

There have previously been public announcements by President Trump and members of the U.S. Congress regarding their plans to repeal and replace the Affordable Care Act. We cannot predict whether future healthcare initiatives, including at the federal level, will be initiated or the effect any such initiatives could have on our business, financial condition or results of operations.

The Eliminating Kickbacks in Recovery Act of 2018

The Eliminating Kickbacks in Recovery Act of 2018, or EKRA, prohibits payments for referrals to recovery homes, clinical treatment facilities, and laboratories. EKRA's reach extends beyond federal healthcare programs to include private insurance (i.e., it is an "all payer" statute). For purposes of EKRA, the term "laboratory" is defined broadly and without reference to any connection to substance use disorder treatment. EKRA is a criminal statute and violations can result in fines of up to $200,000, up to 10 years in prison, or both, per violation. The law includes a limited number of exceptions, some of which closely align with corresponding Anti-Kickback Statute exceptions and safe harbors and others that materially differ.

Information Blocking Prohibition

On May 1, 2020, the Office of the National Coordinator for Health Information Technology promulgated final regulations under the authority of the 21st Century Cures Act to impose new conditions to obtain and maintain certification of certified health information technology and prohibit certain covered actors-developers of certified health information technology, health information networks / health information exchanges, and healthcare providers (including laboratories)-from engaging in activities that are likely to interfere with the access, exchange or use of electronic health information (information blocking). The final regulations further defined exceptions for activities that are permissible, even though they may have the effect of interfering with the access, exchange or use of electronic health information. Originally, the Office of the National Coordinator for Health Information Technology established an information blocking effective date of November 2, 2020; however, the agency subsequently issued an interim final rule to extend the effective date to April 5, 2021. Under the 21st Century Cures Act, healthcare providers that violate the information blocking prohibition will be subject to appropriate disincentives, which the U.S. Department of Health and Human Services has yet to establish through required rulemaking. Developers of certified information technology and health information networks / health information exchanges, however, may be subject to civil monetary penalties of up to $1 million per violation. The U.S. Department of Health and Human Services Office of Inspector General has the authority to impose such penalties and the final rule relating to such developers went into effect in August 2023. The U.S. Department of Health and Human Services Office of Inspector General began investigating health care providers for information blocking beginning on July 31, 2024, and declared it would exercise its enforcement discretion in relation to any determinations regarding conduct that occurred prior to July 31, 2024.

Anti-Kickback Statutes

The federal healthcare programs' Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind in return for referring an individual for the furnishing of or arranging for the furnishing of any good or service, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid, or the purchasing, leasing, ordering or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item payable under such programs.

The definition of "remuneration" has been broadly interpreted to include anything of value, including, for example, gifts, certain discounts, the furnishing of free supplies, equipment or services, credit arrangements, payment of cash and waivers of payments. Several courts have interpreted the statute to mean that if any one purpose of remuneration is to induce or reward referrals of federal healthcare program payable business, the statute has been violated. The statute contains a number of statutory exceptions and the U.S. Department of Health and Human Services has created several regulatory "safe harbors." Arrangements that meet all of the conditions of an applicable exception or safe harbor are protected from liability under the Anti-Kickback Statute. However, the failure to fit an arrangement within an exception or a safe harbor does not necessarily mean that the statute has been violated or that the arrangement will be prosecuted. Penalties for violations include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Violations of the Anti-Kickback Statute are also actionable under the federal False Claims Act.

Many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to items or services reimbursed by any third-party payer, including commercial insurers.

Federal False Claims Act

The federal False Claims Act, which includes "whistleblower" or "qui tam" provisions, imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by the federal government. The qui tam provisions of the federal False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has violated the federal False Claims Act and to share in any monetary recovery.

In recent years, the number of suits brought against healthcare providers by private individuals has increased dramatically. In addition, various states have enacted false claims laws analogous to the federal False Claims Act, and many of these state laws apply where a claim is submitted to any third-party payer and not merely the federal government.

The federal government has used the False Claims Act to assert liability on the basis of, among other things, causing physicians to order excessive or unnecessary services, providing false documentation in support of claims, kickbacks, off-label promotion of products, and Stark Law violations and other improper referrals, in addition to the more predictable allegations as to misrepresentations with respect to the services rendered. Our future activities relating to billing, compliance with certain regulations and Medicare reimbursement requirements, physician and other healthcare provider financial relationships and the sale and marketing of our products may be subject to scrutiny under these laws.

State Privacy Laws

U.S. state comprehensive consumer privacy laws, such as the California Consumer Privacy Act, or the CCPA, secure privacy rights for consumers and impose obligations on us, including providing specific disclosures in privacy notices and affording consumers with certain rights concerning their personal data. Over a third of U.S. states have similarly adopted comprehensive consumer privacy laws and similar laws are being considered in several other states, as well as at the federal and local levels.

Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs of ensuring and maintaining compliance. In addition, we cannot predict how future regulatory conditions will affect our business and may also have an adverse impact on our results of operations or financial condition.

Foreign Jurisdictions

Laws and regulations outside of the United States also apply to our products. We currently produce products, which are CE labeled and subject to the In Vitro Diagnostic Medical Devices Directive (98/79/EC), or IVDD, a European Union, or EU, directive. Some of our products are currently labeled by self-declaration based on their intended use or certified by a Notified Body for Compliance to the IVDD requirements. A product that is not CE marked is automatically considered to be non-compliant. Appointed national enforcement agencies monitor the market for violations and imported products are checked for compliance at customs offices.

No in vitro device or accessory may be placed on the market or put into service unless it satisfies the essential requirements set forth in the IVDD. Devices considered to meet the essential requirements must bear the CE marking of conformity, placed by the manufacturer, when introduced to the market. A manufacturer placing devices on the market in its name must notify its national competent authorities.

These CE-labeled products are also falling under the requirements of the In Vitro Diagnostic Regulation (2017/746) (IVDR). The IVDR requirements were applied starting May 26, 2022. The European Commission recently confirmed adoption of a proposal for a progressive rollout of the IVDR to prevent disruption in the supply of in vitro diagnostic products to the market. The proposal does not change any requirements of the IVDR or the implementation date but changes the transitional provisions to allow a progressive rollout based on the risk level of the device.

In accordance with these timelines, our current CE-marked products will remain available to customers throughout the transition period. There is currently no anticipated supply risk based on the implementation of the IVDR in May 2022. The certification for our products under the IVDR is in progress with our notified body and certification of these products to the IVDR shall be achieved within the transition timeframes. We also worked with our notified body to bring the quality management system at the sites to be compliant with IVDR requirements.

Certain of our products also comply with the CMDCAS, which is a system designed to implement Canadian regulations requiring some medical devices be designed and manufactured under a registered QMS. The SCC and Health Canada's Therapeutic Products Directorate developed this system. CMDCAS came into effect January 1, 2003.

GDPR and UK GDPR

The General Data Protection Regulation (EU) 2016/679, or the GDPR, is a regulation on data protection and privacy in the EU, and the European Economic Area, or the EEA. It also addresses the transfer of personal data outside the EU and EEA. The regulation contains provisions and requirements related to the processing of personal data of individuals, or data subjects, who reside in the EEA, and applies to any enterprise-regardless of its location-that is processing the personal data of data subjects inside the EEA. The UK GDPR imposes similar requirements for personal data about United Kingdom, or UK, data subjects.

Controllers and processors of EEA and UK personal data must have a legal basis to process personal data and put in place appropriate technical and organizational measures to implement the data protection principles. Business processes that handle personal data must be designed and built with consideration of the GDPR and UK GDPR principles and provide safeguards to protect personal data. Data controllers and processors must design information systems with privacy in mind.

Violators of the GDPR or UK GDPR may be fined up to €20 million (£17.5 million in the UK) or up to 4% of the annual worldwide turnover of the preceding financial year, whichever is greater.

Our business or financial results may be adversely impacted by adhering to these regulatory requirements and the related costs of ensuring and maintaining compliance.

Employees and Human Capital Resources

On December 31, 2025, we had 765 employees, of which 761 were full-time employees. We had 145 employees in manufacturing operations and support, 186 in research and development, 252 in sales and marketing and 182 in general and administrative positions. As of December 31, 2025, 706 employees were located in the U.S. and 59 were located outside of the U.S.

The diagnostics industry is characterized by rapid product development and technological advances, which require an adept and skilled workforce. We believe that it is critical to attract, develop and retain employees with the experience, knowledge, expertise and vision capable of not only operating, but also excelling, in this complex and competitive business environment, including competing against larger competitors and developing and commercializing new products, new and improved technologies and new applications for our existing technologies.

We consider our employees to be our greatest asset and therefore focus on attracting, developing, retaining and motivating our employees. Our recruitment and retention strategies include partnerships with external agencies to help hire top talent, onboarding processes, a leadership development program and a professional work environment that promotes innovation and rewards performance.

We believe employee career development is an investment in our employees' skills and our future. We offer our employees various training opportunities free of charge and during working hours. For example, we use the LinkedIn Learning platform, a learning library and repository for self-guided personal and professional learning opportunities for our employees.

In addition, we believe it is important to have regular engagement with our employees to understand their needs. Apart from regular scheduled meetings with managers, monthly town hall meetings and quarterly earnings reports and calls, we also conduct annual anonymous employee surveys to understand current employee sentiment, areas we are excelling in as well as areas for improvement.

Our total compensation for employees includes a variety of components that support sustainable employment and the ability to build a strong financial future, including competitive market-based pay and comprehensive benefits. In addition to earning a base salary, eligible employees are compensated for their contributions to our goals with both short-term cash incentives and long-term equity-based incentives. Through our global pay philosophy, principles and consistent implementation, we are committed to providing fair and equitable pay for employees. Eligible full-time employees in the U.S. also have access to medical, dental, and vision plans; savings and retirement plans; an employee stock purchase plan; and other resources.

Programs and benefits differ internationally for a variety of reasons, such as local legal requirements, market practices, and negotiations with employee representative bodies.

From time to time, we also employ independent contractors, consultants and temporary employees to support our operations. Currently, our SSP production group in Sweden is represented by an IF Metall collective bargaining agreement. None of our other employees are represented by a union or are subject to collective bargaining agreements. We have never experienced a work stoppage and believe that our relations with our employees are good. See "Risk Factors-General Risk Factors-Disputes with labor unions may adversely affect our ability to operate in our Sweden facility and may impact our financial results."

We have a zero-tolerance policy for discrimination and have a Diversity, Equity, and Inclusion committee to engage, retain and develop talent from diverse backgrounds by facilitating diversity, equity and inclusion advocacy through event sponsorship, learning and client engagement. We have increased the diversity of our Board of Directors and leadership teams and continue to focus on maintaining a diverse organization. Our senior leadership team includes leaders with diverse skills, experience, racial backgrounds and genders. Our employees come from numerous countries and various backgrounds and we strive to provide a diverse and inclusive environment.

Environmental Matters

Our operations require the use of hazardous materials (including biological materials), which subjects us to a variety of federal, state and local environmental and safety laws and regulations. Some of these regulations provide for strict liability, or holding a

party potentially liable without regard to fault or negligence. We could be held liable for damages and fines as a result of our, or others', business operations should contamination of the environment or individual exposure to hazardous substances occur. In addition, we could be subject to significant fines for failure to comply with applicable environmental, health and safety requirements. We cannot predict how changes in laws or new regulations will affect our business, operations or the cost of compliance.

In addition, we look for ways to minimize our impact on the environment. Our main buildings headquartered in California are energy efficiency certified and meet stringent San Francisco Bay Area requirements for environmental impact, and several of our offices are in new energy efficient buildings. Our offices also provide recycling and use low flow fixtures to conserve water, and we take additional measures to conserve energy through LED fixtures, light timers/sensors, and thermostat regulation.

Available Information

Our website is www.caredx.com. Information contained on, or that can be accessed through, our website is not part of this Annual Report on Form 10-K, and you should not consider information on our website to be part of this report unless specifically incorporated herein by reference. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act, are available free of charge on our investor relations website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address of the website is www.sec.gov.

‌ITEM 1A. RISK FACTORS

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading "Risk Factors" and should be carefully considered, together with other information in this Annual Report on Form 10-K, or this Form 10-K, and our other filings with the SEC before making an investment decision regarding our common stock.

We have a history of losses, and we expect to incur net losses for the next several years.

We receive a substantial portion of our revenues from Medicare, and the loss of, or a significant reduction in, reimbursement from Medicare would severely and adversely affect our financial performance.

Our financial results currently are largely dependent on sales of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests and products, and we will need to generate sufficient revenues from these and other solutions and tests we develop to grow our business.

We are and could become subject to legal proceedings that could be time-consuming, result in costly litigation and settlements/judgments, require significant amounts of management attention and result in the diversion of significant operational resources, which could adversely affect our business, financial condition and results of operations.

The development and commercialization of additional diagnostic solutions are key to our growth strategy. New test or product development involves a lengthy and complex process, and we may not be successful in our efforts to develop and commercialize additional diagnostic solutions.

The field of diagnostic testing in transplantation is evolving and is subject to rapid technological change. If we are unable to develop solutions to keep pace with rapid medical and scientific change, our operating results could be harmed.

If clinicians, hospital administrators, medical centers and laboratories do not adopt our diagnostic solutions, we will not achieve future sales growth.

Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.

Transplant centers may not adopt AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or our other solutions due to historical practices or due to more favorable reimbursement policies associated with other means of monitoring transplants.

If we cannot maintain existing clinical collaborations and enter into new ones, our efforts to commercialize and develop products could be delayed.

If we are unable to successfully manage our growth and support demand for our tests, our business may suffer.

Our past revenue growth rates may not be indicative of future growth, and we may not grow at all, and revenue may decline.

If our laboratory facility in the U.S. becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future testing solutions, if any, and our business will be harmed.

Investors' expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.

Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.

If we seek to and are unable to raise additional capital on acceptable terms in the future, it may limit our ability to develop and commercialize new diagnostic solutions and technologies, and we may have to curtail or cease operations.

The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, clinicians and laboratory and field personnel could adversely affect our business.

Recent and future acquisitions and investments could disrupt our business, harm our financial condition and operating results, dilute your ownership of us and increase our debt or cause us to incur significant expense.

We rely extensively on third-party service providers. Failure of these parties to perform as expected, or interruptions in our relationship with these providers or their provision of services or supplies to us, could interfere with our ability to provide test results for our testing services business and kits for our products business.

Security breaches, loss of data, or other disruptions could compromise sensitive information, prevent access to critical information, expose us to liability, and adversely affect our business and our reputation.

We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business.

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

Our operating results may be adversely affected by unfavorable economic and market conditions.

Billing complexities associated with obtaining payment or reimbursement for our current and future solutions may negatively affect our revenue, cash flows and profitability.

Healthcare reform measures could hinder or prevent the commercial success of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung.

To operate our laboratory, we have to comply with the CLIA and federal and state laws and regulations governing clinical laboratories and laboratory-developed tests, including FDA regulations.

We are subject to numerous fraud and abuse and other laws and regulations pertaining to our business, the violation of any one of which could harm our business.

Our competitive position depends on maintaining intellectual property protection.

Our business is dependent on licenses from third parties.

Our operating results may fluctuate, which could cause our stock price to decrease.

The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part of your investment.

Risk Factors

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this Annual Report on Form 10-K, including the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and related notes, before investing in our common stock. If any of the following risks occur, our business, financial condition, results of operations and prospects could be materially harmed. In that event, the market price of our common stock could decline, and you could lose part or all of your investment.

Risks Related to Our Business

We have incurred substantial net losses since our inception, and we may continue to incur additional losses for the next several years. For the year ended December 31, 2025, our net loss was $21.4 million, and for the year ended December 31, 2024, our net income was $52.5 million. As of December 31, 2025, we had an accumulated deficit of $735.4 million. We expect to continue to incur significant operating expenses and anticipate that our expenses will increase due to costs relating to, among other things:

researching, developing, validating and commercializing potential new testing services, products and patient and digital solutions, including additional expenses in connection with our continuing development and commercialization of our testing services and product portfolio, and other future solutions;

developing, presenting and publishing additional clinical and economic utility data intended to increase payer coverage and clinician adoption of our current and future solutions;

expansion of our operating capabilities;

maintenance, expansion and protection of our intellectual property portfolio and trade secrets;

the process of fully integrating acquired companies and operations and the associated potential disruptions to our business;

future clinical trials;

expansion of the size and geographic reach of our sales force and our marketing capabilities to commercialize our existing and future solutions;

employment of additional clinical, quality control, scientific, customer service, laboratory, billing and reimbursement and management personnel;

compliance with existing and changing laws, regulations and standards, including those relating to corporate governance and public disclosure and regulations implemented by the Securities and Exchange Commission, or the SEC, and The Nasdaq Stock Market LLC;

ongoing litigation;

employment of operational, financial, accounting and information systems personnel, consistent with expanding our operations; and

failure to achieve expected operating results may cause a future impairment of goodwill or other assets.

Even if we achieve significant revenues, we may not become profitable, and even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain consistently profitable could adversely affect the market price of our common stock and could significantly impair our ability to raise capital, expand our business or continue to pursue our growth strategy or even continue to operate. For a detailed discussion of our financial condition and results of operations, see "Management's Discussion and Analysis of Financial Condition and Results of Operations."

For the year ended December 31, 2025, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 46% of testing services revenue. However, we may not be able to maintain or increase our tests reimbursed by Medicare for a variety of reasons, including changes in reimbursement practices, general policy shifts, or reductions in reimbursement amounts. We cannot predict whether Medicare reimbursements will continue at the same payment amount or with the same breadth of coverage in the future, if at all. For example, on December 30, 2024, we

received a CPT code for our AlloSure Kidney, AlloSure Heart and AlloSure Lung tests (PLA Code 0540U), which subjects such tests to a repricing process.

On November 25, 2025, CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U. As a result, PLA Code 0540U was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753. The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to the pricing for AlloSure Heart and AlloSure Lung tests.

The Protecting Access to Medicare Act of 2014, or PAMA, included a substantial new payment system for clinical laboratory tests under the Clinical Laboratory Fee Schedule, or CLFS.

On February 3, 2026, the "Consolidated Appropriations Act, 2026" was passed amending the PAMA law. The legislation requires us, and other laboratories, to report private payor rates paid between January 1, 2025 and June 30, 2025 to CMS with a reporting period from May through July 2026. The volume-weighted median of the rates reported for each test would set the Medicare Clinical Laboratory Fee Schedule rate for certain of our tests in calendar years 2027 to 2029. We do not anticipate that the reporting will have a material impact on our current Medicare pricing.

On August 10, 2023, MolDX and Noridian released a draft proposed revision to the LCD (DL38568, Palmetto; DL38629, Noridian) that, if adopted, would revise the existing foundational LCD, MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568 and L38629). On August 16, 2024, CMS issued a press release entitled "MolDX Local Coverage Determination Statement," announcing that after careful consideration of the feedback received from interested parties, as well as the public comments and further review of evidence, the Medicare Administrative Contractors, or MACs, decided not to finalize the proposed LCD issued on August 10, 2023. CMS further stated that due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. CMS stated that neither it nor the MACs have changed coverage for the blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances, and explained that transplant patients would continue to have access to these blood tests, including: when there are signs or symptoms of rejection; after a physician-assessed pretest, including for surveillance testing; after an indeterminate biopsy; as a replacement for a biopsy when deemed clinically appropriate by the patient's qualified physician; and for evaluation of the adequacy of immunosuppression. On July 17, 2025, MolDX and Noridian released a new draft proposed revision to the existing foundational LCD (DL40058, DL40060) with a revised accompanying billing article (DA60146, DA60152), or the Proposed LCD. The Proposed LCD, which underwent public comment, may introduce new coverage criteria, utilization limitations, and a new bundled payment concept for certain CareDx testing, which could lead to lower rates of reimbursement. MolDX and Noridian have 365 days from the date of issuance to finalize the Proposed LCD. We cannot predict the ultimate outcome of the LCD process, including as it relates to the Proposed LCD, and whether it will produce changes in coverage, reimbursement practices, utilization limitations, or payment amounts, any of which could adversely affect our business, operating results and prospects.

If future reimbursement price or coverage levels are lower than the current prices or coverage level, our revenues and our ability to achieve profitability could be impaired, and the market price of our common stock could decline. We may also not be able to maintain or increase the portion of our tests reimbursed by Medicare for a variety of other reasons, including changes in reimbursement practices and general policy shifts.

On a five-year rotational basis, Medicare requests bids for its regional MAC services. The MAC for California is currently Noridian Healthcare Solutions. Our current Medicare coverage through Noridian provides for reimbursement for tests performed for qualifying Medicare patients throughout the United States so long as the tests are performed in our California laboratory. We cannot predict whether Noridian or any future MAC will continue to provide reimbursement for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, or AlloSure Lung at the same payment amount or with the same breadth of coverage in the future, if at all. Additional changes in the MAC processing Medicare claims for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare or AlloSure Lung could impact the coverage or payment amount for our tests and our ability to obtain Medicare coverage for any products we may launch in the future.

Any decision by CMS or its local contractors to reduce or deny coverage for our tests would have a significant adverse effect on our revenue and results of operations and ability to operate and raise capital. Any such decision could also cause affected clinicians treating Medicare-covered patients to reduce or discontinue the use of our tests.

We expect that sales of testing services and products will account for a substantial portion of our revenue for at least the next two years. If we are unable to increase sales of our testing services or products or successfully develop and commercialize other solutions, tests or enhancements, or if we do not continue our Medicare reimbursement submissions for AlloSure Kidney at the same levels, our revenues and ability to achieve profitability would be impaired, and the market price of our common stock could decline.

Successful commercialization of AlloSure Kidney, AlloMap Heart and AlloSure Heart, HeartCare and AlloSure Lung depends, in large part, on the availability of coverage and adequate reimbursement from government and private payers. Favorable third-party payer coverage and reimbursement are critical to the commercial success of a diagnostic testing service, and if we are not able to secure positive coverage determinations and reimbursement levels, our business will be materially adversely affected. Third-party payers have in the past disallowed, and may in the future disallow, in whole or in part, requests for reimbursement based on determinations that the member is not eligible for coverage, certain amounts are not reimbursable under plan coverage, were for services provided that were not medically necessary, were redundant or were not coupled with other specified tests or services or additional supporting documentation is necessary. Retroactive adjustments may change amounts realized from third-party payers. For example, we are currently involved in a dispute with a significant Medicare Advantage payer concerning payment of claims. We are seeking recovery of claims amounts that we believe were improperly denied, underpaid or recouped. The payer has also asserted entitlement to recoup additional previously paid claims pursuant to the provisions under the contract. We are also subject to claims reviews and/or audits by third-party payers, including governmental audits of our Medicare claims, and have in the past been required to repay these payers in certain circumstances where a preliminary finding was made that we were incorrectly reimbursed. We may also in the future be required to repay these payers if a finding is made that we were incorrectly reimbursed.

In addition, several payers and other entities conduct technology assessments of new medical tests and devices and provide and/ or sell the results of their assessments to other parties. These assessments may be used by third-party payers and healthcare providers as grounds to deny coverage for or refuse to use a test or procedure. We have received a negative technology assessment from at least one of these entities and could receive more.

Seeking payer coverage and other approvals is a time-consuming and costly process. If third-party payers decide not to cover our diagnostic testing services or if they offer inadequate payment amounts, our ability to generate revenue from AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future solutions could be limited.

We have in the past been, and from time to time in the future may become, involved in lawsuits, claims and proceedings incident to the ordinary course of, or otherwise in connection with, our business. We intend to defend ourselves vigorously, and we believe that we have good and substantial defenses to the claims alleged in the suits, but there is no guarantee that we will prevail. See Note 8, Commitments and Contingencies, to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K under the caption "Litigation and Indemnification Obligations", which is incorporated herein by reference.

Litigation is inherently unpredictable. It is possible that an adverse result in one or more of these possible future events could have a material adverse effect on us, including increased expenses to defend, settle or resolve such litigation. Such matters may cause us to incur costly litigation and/or substantial settlement charges, divert management attention, result in adverse judgments, fines, penalties, injunctions or other relief, and may result in loss of customer or investor confidence regardless of their merit or ultimate outcome.

Key elements of our strategy are to discover, develop, validate and commercialize a portfolio of new diagnostic solutions. We cannot be sure that we will be able to successfully complete development of or commercialize any of our planned future solutions, or that they will prove to be capable of reliably being used for organ surveillance in the heart or in other types of organs. Before we can successfully develop and commercialize any of our currently planned or other new diagnostic solutions, we will need to:

conduct substantial research and development;

obtain the necessary testing samples and related data;

conduct clinical validation studies;

expend significant funds;

expand and scale-up our laboratory processes;

expand and train our sales force;

gain acceptance from ordering clinicians at a larger number of transplant centers;

gain acceptance from ordering laboratories associated with transplant centers; and

seek and obtain regulatory clearance or approvals of our new solutions, as required by applicable regulations.

We have included a discussion of a number of anticipated targets in this Annual Report on Form 10-K. The actual timing of accomplishment of these targets could vary dramatically compared to our estimates, in some cases for reasons beyond our control. We cannot be certain that we will meet our projected targets and if we do not meet these targets as publicly announced, the commercialization of our diagnostic solutions may be delayed or may not occur at all and, as a result, our business will suffer and our stock price may decline.

This process involves a high degree of risk and may take up to several years or more. Our test development and commercialization efforts may be delayed or fail for many reasons, including:

failure of the test at the research or development stage;

difficulty in accessing suitable testing samples, especially testing samples with known clinical results;

delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a timely and cost-effective manner; or

failure to obtain or maintain necessary clearances or approvals to market the test.

In addition, the publication of clinical data in peer-reviewed publications is necessary to promote clinician adoption and favorable reimbursement decisions. Clinicians typically take a significant amount of time to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party reimbursement. It is critical to the success of our sales efforts that we educate a sufficient number of clinicians and administrators about AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and our future solutions, and demonstrate the clinical benefits of these solutions. If our solutions fail to gain commercial acceptance by patients, clinicians or third-party payers, our business and results of operations would be negatively affected.

The administration of clinical and economic utility studies is expensive and demands significant attention from our management team. Data collected from these studies may not be positive or consistent with our existing data, or may not be statistically significant or compelling to the medical community. If the results obtained from our ongoing or future studies are inconsistent with certain results obtained from our previous studies, adoption of our current and future products and patient and digital solutions would suffer and our business would be harmed.

Few research and development projects result in commercial products, and success in early clinical studies often is not replicated in later studies. At any point, we may abandon development of new diagnostic solutions, or we may be required to expend considerable resources repeating clinical trials, which would adversely impact the timing for generating potential revenues from those new diagnostic solutions. In addition, as we develop diagnostic solutions, we will have to make additional investments in our sales and marketing operations, which may be prematurely or unnecessarily incurred if the commercial launch of a test is abandoned or delayed. If a clinical validation study fails to demonstrate the prospectively defined endpoints

of the study, we would likely abandon the development of the test or test feature that was the subject of the clinical trial, which could harm our business.

The field of diagnostic testing in transplantation is evolving. Although there have been few advances in technology relating to organ rejection in transplant recipients, the market for medical diagnostic companies is marked by rapid and substantial technological development and innovations that could make AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, and our other products and patient and digital solutions, including those in development, outdated. We must continually innovate, expand and update our test offerings to address unmet needs in monitoring transplant-related conditions. AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, and our other products and patient and digital solutions, including those in development, could become obsolete unless we continually innovate, enhance and expand our product offerings to include new clinical applications. If we are unable to demonstrate the effectiveness of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or our other products and patient and digital solutions and future diagnostic solutions and tests, if any, compared to new methodologies and technologies, then sales of our tests, products and patient and digital solutions could decline, which would harm our business and financial results.

Clinicians and healthcare administrators are traditionally slow to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party reimbursement. It is critical to the success of our sales efforts that we continue to educate clinicians, administrators and laboratory directors about our testing services, products and patient and digital solutions, and demonstrate the clinical and diagnostic benefits of these services, products and patient and digital solutions. We believe that clinicians, transplant centers and laboratories may not use our services, products and patient and digital solutions unless they determine, based on published peer-reviewed journal articles, the experience of other clinicians or laboratory verification, that our services, products and patient and digital solutions provide accurate, reliable and cost-effective information that is useful in pre-transplant matching and monitoring their post-transplant recipients. The acceptance of our services, products and patient and digital solutions will depend upon our ability to demonstrate the safety and efficacy, advantages, short and long-term clinical performance and cost-effectiveness of our services, products and patient and digital solutions.

Our product kits are sold to hundreds of laboratories, mainly in Europe and the U.S. Laboratories order our products based on the accuracy, speed and cost of the test together with the cost and availability of equipment on which to run the test. Switching to or adopting our products may require the purchase of new and costly testing equipment. To attract new laboratory customers, the performance of our products must provide performance or cost advantages over similar products sold by our competitors.

If clinicians, hospital administrators and laboratories do not adopt or continue to use our tests and products or our future solutions and tests, our business and financial results will suffer.

Historically, our financial results, including our net income (loss), have been, and we expect that our operating results will continue to be, subject to quarterly fluctuations as a result of a variety of factors, many of which are outside of our control, including those listed elsewhere in this "Risk Factors" section. In addition, to the extent that we continue to spend considerable amounts on research and development expenditures, commercialization efforts for new diagnostic solutions and new acquisitions and their related integration into our business, we expect to incur costs before achieving any anticipated future benefits.

If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

Due to the historically limited monitoring options and the well-established coverage and reimbursement for biopsies, clinicians are accustomed to monitoring for acute rejection in kidney and heart transplant recipients by utilizing biopsies. Many clinicians

use AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung in parallel with biopsies rather than as an alternative to biopsies. While we do not market AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare or AlloSure Lung as biopsy alternatives, per se, if treatment center administrators view our test as an alternative to a biopsy but believe they would derive more revenue from the performance of biopsies, such administrators may be motivated to reduce or avoid the use of our test. While biopsies are less common for monitoring kidney transplant patients, there are transplant centers that manage patients with protocol biopsies, which could impact AlloSure Kidney revenue. We cannot provide assurance that our efforts will increase the use of our test by new or existing customers. Our failure to increase the frequency of use of our test by new and existing customers would adversely affect our growth and revenues.

Our AlloSure Kidney solution for kidney transplant recipients competes against existing diagnostic tests utilized by pathologists, which involves evaluating biopsy samples to determine the presence or absence of rejection. However, because of the risks and discomforts of the invasive kidney biopsy procedure, as well as the expense and relatively low rate of finding moderate to severe grade rejection, biopsy is not a standard practice for surveillance of transplanted kidneys. Additional competition for kidney surveillance diagnostics currently comes from general, non-specific clinical chemistry tests such as serum creatinine, urine protein, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera, Eurofins, iMDx, and Verici have commercially available molecular diagnostics tests. Other entrants with kitted products have indicated they are entering the market for post-transplant surveillance, including Thermo Fisher, Devyser, Bio-Rad, EuroBio, and iMDx.

Competition for our AlloSure Heart, AlloMap Heart, and HeartCare solutions for heart transplant recipients comes largely from biopsies in the first few years, which generally involves evaluating biopsy samples to determine the presence or absence of rejection. Beyond the first year or two, competition for heart transplant surveillance diagnostics includes echocardiography.

Throughout, biopsy and echocardiography are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. This practice has been the standard of care in the United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the various benefits of our test in order to change clinical practice. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera and Eurofins has commercially available molecular diagnostics tests.

Competition for our AlloSure Lung solution for lung transplant recipients comes largely from spirometry to assess lung function and biopsy to diagnose rejection in the first few years. These tests are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs. This practice has been the standard of care in the United States for many years, and we will need to continue to educate clinicians, transplant recipients and payers about the various benefits of our test in order to change clinical practice. Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera, has commercially available molecular diagnostics tests.

We expect the competition for pre-transplant typing and post-transplant surveillance to increase as there are numerous established and startup companies in the process of developing products and services for the transplant market which may directly or indirectly compete with our existing pre- and post-transplant solutions, or our development pipeline. Competition from other companies, especially those with an eye toward transitioning to more automated typing processes, could impact our ability to maintain market share and its current margins. For example, QTYPE competes with other quantitative polymerase chain reaction, or PCR, products including products offered by Thermo Fisher, as well as alternatives to PCR such as next generation sequencing, or NGS, typing products.

Competition for our patient and digital solutions includes various companies that develop application software and operate in the healthcare field. Our competition for patient solutions includes hospital-affiliated pharmacies located on-site at the transplant center and specialty pharmacies that provide transplant-specific care and dispensing services. Our primary competitor for our patient management EMR solution is Phoenix, Epic's transplant application. In addition, other established and emerging healthcare, information technology and service companies may commercialize competitive products including informatics, analysis, integrated genetic tools and services for health and wellness.

The field of clinical surveillance of transplantation is evolving. New and well-established companies are devoting substantial resources to the application of molecular diagnostics to the treatment of medical conditions. Some of these companies may elect to develop and market diagnostic solutions in the post-transplant surveillance market.

Many of our potential competitors may have greater brand recognition or substantially greater financial and technical resources and development, production and marketing capabilities than we do. Others may develop lower-priced, less complex tests that could be viewed by clinicians and payers as functionally equivalent to our AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests, which could force us to lower the current list price of our test and impact our operating margins and our ability to achieve profitability. If we are unable to compete successfully against current or future competitors, we may be unable to increase market acceptance for and sales of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung tests, and our products and patient and digital solutions, which could prevent us from increasing or sustaining our revenues or achieving profitability and could cause the market price of our common stock to decline.

We operate in an environment characterized by rapid development and continuing innovation. We will need to continue to maintain the value of our product offering. To compete successfully, we must continually update our product range and produce continually updated test kits and software. The failure to maintain the quality of our products or inability to keep pace with this innovation could render our existing or future solutions obsolete or less attractive to lab directors and clinicians. Any failure to anticipate or develop new or enhanced solutions in a timely manner could result in decreased revenue and harm to our business and prospects. If we fail to introduce new or enhanced solutions that meet the needs of our customers, we will lose market share and our business, operating results and prospects will be adversely affected.

Our clinical development relies on our ability to secure access to tissue and blood samples, as well as recipient information, including biopsy results and clinical outcomes from the same patient. Furthermore, the studies through which our future solutions are developed may rely on access to multiple samples from the same recipient over a period of time as opposed to samples at a single point in time or archived samples. We will require additional samples and recipient data for future research, development and validation. Access to recipients and samples on a real-time, or non-archived, basis is limited and often on an exclusive basis, and there is no guarantee that future initiatives will be successful in obtaining and validating additional samples. Additionally, the process of negotiating access to new and archived donor and recipient data and samples is lengthy since it typically involves numerous parties and approval levels to resolve complex issues, such as usage rights, institutional review board approval, recipient consent, privacy rights and informed consent of recipients, publication rights, intellectual property ownership and research parameters. If we are not able to acquire or negotiate access to new and archived donor and recipient data and tissue and blood samples with source institutions, or if other laboratories or our competitors secure access to these samples before us, our ability to research, develop and commercialize future solutions will be limited or delayed.

In the past, we have entered into clinical collaborations with highly regarded academic institutions and leading treatment centers in the transplant field. Our success in the future may depend in part on our ability to enter into agreements with other leading institutions in the transplant field. Securing these agreements can be difficult due to internal and external constraints placed on these organizations. Some organizations may limit the number of collaborations they have with any one company so as to not be perceived as biased or conflicted. Organizations may also have insufficient administrative and related infrastructure to enable collaborations with many companies at once, which can extend the time it takes to develop, negotiate and implement a collaboration.

In addition to completing clinical collaborations, publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining coverage and reimbursement for solutions such as ours. Our inability to control when, if ever, results of such studies are published may delay or limit our ability to derive sufficient revenues from any test that may result from a collaboration.

We cannot control the amount and timing of our collaborators' resources that will be devoted to performing their responsibilities under our agreements with them. Our collaborators may choose to pursue alternative technologies in preference to those being developed in collaboration with us. The development, validation and commercialization of our potential solutions may be delayed if collaborators fail to fulfill their responsibilities in a timely manner or in accordance with applicable regulatory requirements or if they breach or terminate their collaboration agreements with us. Any issues arising from these arrangements will affect our ability to serve the entire region, and our reputation may suffer even if we subsequently locate new partners, which may permanently affect our business. Disputes with our collaborators could also impair our reputation or result in development delays, decreased revenues and litigation expenses.

From time to time, we expect to engage in discussions with potential clinical collaborators, which may or may not lead to collaborations. We cannot guarantee that any discussions will result in clinical collaborations or that any clinical studies that may result will be enrolled or completed in a reasonable time frame or with successful outcomes. Once news of discussions regarding possible collaborations becomes known in the medical community, regardless of whether the news is accurate, failure to announce a collaborative agreement or the other entity's announcement of a collaboration with an entity other than us may result in adverse speculation about us, our current and future solutions or our technology, resulting in harm to our reputation and our business.

As the volume of the tests that we perform grows, we will need to continue to ramp up our testing capacity, implement increases in scale and related processing, customer service, billing and systems process improvements and expand our internal quality assurance program to support testing on a larger scale. We will also need additional certified laboratory scientists and other scientific and technical personnel to process our tests. We cannot be certain that any increases in scale, related improvements and quality assurance will be successfully implemented or that appropriate personnel will be available. As additional products are developed, we may need to bring new equipment on-line, implement new systems, technology, controls and procedures and hire personnel with different qualifications. We plan to expand our sales force to support additional products. There is significant competition for qualified, productive sales personnel with advanced sales skills and technical knowledge in our field. Our ability to achieve significant growth in revenue in the future will depend, in large part, on our success in recruiting, training and retaining sufficient qualified sales personnel.

The value of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung depends, in large part, on our ability to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung tests on a timely basis and at a high quality standard, and on our reputation for such timeliness and quality. Failure to implement necessary procedures, transition to new equipment or processes or hire new personnel could result in higher costs of processing or an inability to meet market demand in a timely manner. In addition, changes in the funding of the FDA or other government agencies or comparable foreign regulatory authorities could hinder, prevent or delay their regulatory review and approval processes or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely.

There can be no assurance that we will be able to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or our future solutions, if any, on a timely basis at a level consistent with demand, that our efforts to scale our commercial operations will not negatively affect the quality of test results or that we will be successful in responding to the growing complexity of our testing operations. If we encounter difficulty meeting market demand for our current and future solutions, our reputation could be harmed and our future prospects and our business could suffer.

In addition, our growth may place a significant strain on our management, operating and financial systems and our sales, marketing and administrative resources. As a result of our growth, our operating costs may escalate even faster than planned, and some of our internal systems may need to be enhanced or replaced. If we cannot effectively manage our expanding operations and our costs, we may not be able to grow effectively or we may grow at a slower pace, and our business could be adversely affected.

From 2024 to 2025, our revenue increased from $333.8 million to $379.8 million, which represents an annual increase of 14%. In the future, our revenue may not grow at all and it may continue to decline. We believe that our future revenue will depend on, among other factors:

the continued usage and acceptance of our current and future solutions;

demand for our testing services, products and patient and digital solutions;

the introduction and acceptance of new or enhanced products or services by us or by competitors;

our ability to maintain reimbursement for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung and secure reimbursement for our future solutions;

our decision to continue our Medicare reimbursement submissions for AlloSure Kidney;

our decision to issue future financial guidance and the terms of such guidance;

our ability to anticipate and effectively adapt to developing markets and to rapidly changing technologies;

our ability to attract, retain and motivate qualified personnel;

the initiation, renewal or expiration of significant contracts with our commercial partners;

pricing changes by us, our suppliers or our competitors; and

Disclaimer

CareDx Inc. published this content on April 30, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 30, 2026 at 23:45 UTC.