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• Exact Sciences for organ transplant monitoring.
• Natera, but specialized in diagnostics for organ transplant patients.

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Major products and services of CareDx (CDNA) include:

• AlloSure® Kidney: A non-invasive blood test that measures donor-derived cell-free DNA (dd-cfDNA) to monitor for active rejection in kidney transplant recipients.
• AlloSure® Heart: A non-invasive blood test that measures donor-derived cell-free DNA (dd-cfDNA) to monitor for active rejection in heart transplant recipients.
• AlloMap® Heart: A gene expression profiling (GEP) blood test used to assess the risk of moderate-to-severe acute cellular rejection in heart transplant recipients.
• AlloView™: A digital solution that integrates a transplant patient's clinical and molecular data, including AlloSure and AlloMap results, into a single platform for clinician review.

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CareDx (CDNA) sells its diagnostic testing services and digital health solutions primarily to other organizations within the healthcare system, rather than directly to individuals. While individual patients are the ultimate beneficiaries of their technology, CareDx's direct customers are the institutions and professionals responsible for patient care.

CareDx serves a broad base of customers in the organ transplantation field. It does not typically disclose specific named "major customer companies" (like individual hospital systems or clinics) in its public filings, as its revenue is generally distributed across a large number of transplant programs. Instead, its customers fall into the following categories:

• Transplant Centers: These are specialized medical facilities, often part of larger hospitals or university medical centers, that perform organ transplant surgeries and provide pre- and post-transplant care. They utilize CareDx's tests to monitor transplant patients for organ rejection and infection.
• Hospitals: General hospitals and health systems, particularly those with transplant programs, are key customers. They incorporate CareDx's diagnostic tools into their patient management protocols.
• Clinics and Physician Practices: Nephrology, cardiology, and other specialized clinics and individual physician practices that manage transplant patients also order CareDx's tests and utilize their digital health platforms.

Because CareDx's business model involves providing specialized diagnostic services to a vast network of healthcare providers, no single "customer company" typically accounts for a significant portion of its revenue. Therefore, specific names of publicly traded customer companies are not applicable in this context.

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• Thermo Fisher Scientific, Inc. (TMO)

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John W. Hanna, President and Chief Executive Officer

John W. Hanna has served as President and Chief Executive Officer of CareDx since April 15, 2024. He brings over two decades of executive leadership experience in molecular diagnostics and life sciences tools. Prior to CareDx, Hanna was the Chief Executive Officer of Apton Biosystems, Inc., where he led the development of a high-throughput next-generation sequencing platform. Apton Biosystems, Inc. was acquired by Pacific Biosciences of California, Inc. in August 2023. He then served as Vice President of Corporate Development at Pacific Biosciences. Hanna also spent ten years at Veracyte, Inc., an oncology diagnostics company, holding roles such as Chief Commercial Officer and Vice President of Marketing. His earlier career includes leadership positions at Humana and IBM.

Nathan Smith, Chief Financial Officer

Nathan Smith joined CareDx as Chief Financial Officer in August 2025. He possesses extensive expertise in corporate finance, investor relations, mergers and acquisitions, and strategic planning. Before joining CareDx, Smith spent 14 years at Myriad Genetics, where he held senior leadership positions including SVP of Finance, Investor Relations, and Treasury, and Corporate Controller, helping to scale revenues from $300 million to over $700 million. He also held recent CFO positions at Blackrock Neurotech and WIN Brands.

Keith Kennedy, Chief Operating Officer

Keith Kennedy is CareDx's Chief Operating Officer. He has over 20 years of executive leadership experience in healthcare, spanning global diagnostics, biopharma services, and contract development and manufacturing organizations (CDMO). Kennedy most recently served as Chief Financial Officer at PharmaLogic Holdings Corp. At Veracyte, he held positions as Chief Operations Officer, Chief Financial Officer, and Secretary. Kennedy's background also includes executive roles at MCG Capital Corporation and GE Capital, and he served as an Executive in Residence at Arlington Capital Partners. He was also an Officer in the U.S. Air Force.

Jessica Meng, Chief Commercial Officer

Jessica Meng is CareDx's Chief Commercial Officer. She brings over 20 years of commercial experience with deep expertise in developing successful commercial strategies for both established companies and entrepreneurial ventures within the pharmaceutical and molecular diagnostics industries. Meng previously served as Chief Commercial Officer at DELFI Diagnostics and General Manager of Women's Health at Myovant Sciences. Her prior experience includes sales and marketing leadership roles at Veracyte and Genentech.

Jennifer Foley, Chief Product Officer

Jennifer Foley is CareDx's Chief Product Officer. She has over 25 years of global experience in commercial, product development, and clinical operations across various disease areas such as immunology, oncology, cardiology, and neuroscience. Foley spent nearly two decades at Genentech, where she held progressively responsible positions overseeing pharmaceutical development, clinical operations, and marketing organizations. She also worked as a strategy consultant for Easton Associates, a firm dedicated to serving life sciences clients. Foley began her healthcare career in sales at Roche and later at SmithKline Beecham (now GSK).

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The key risks to CareDx's business (CDNA) include:

1. Reimbursement Changes and Regulatory Risks: CareDx faces significant uncertainty due to proposed and actual changes in reimbursement policies and regulatory oversight, particularly from Medicare. Proposed local coverage decisions (LCDs) could negatively impact the company's core testing business and near-term growth. Updates from Palmetto MolDx have introduced more restrictive language regarding appropriate use and testing frequency for molecular tests assessing rejection risk in solid organs, which could have negative implications for CareDx. The company has previously experienced year-over-year revenue declines in its testing services segment attributed to Medicare billing article revisions. These regulatory shifts can directly affect the commercial success of CareDx's diagnostic tests.
2. Competition and Lack of Durable Competitive Advantage: The transplant diagnostics market is highly competitive, leading to potential pricing pressures and increased demands for marketing efforts. Some analyses suggest that CareDx operates in a fragmented market and lacks a clear "moat" or durable competitive advantage to protect its market position, leading to a poor risk-reward profile. The expiration of key patents, such as the AlloMap patent in March 2024, coupled with declining test volumes, could pose a significant risk to the company's revenue streams.
3. Litigation and Patent Challenges: CareDx has been involved in considerable patent litigation, notably with Natera. While a district court recently overturned a jury verdict and ruled that the patents asserted against CareDx were invalid, the possibility of appeals still exists. Earlier legal disputes have resulted in substantial settlements, highlighting the financial impact of such challenges. Furthermore, the broader legal landscape surrounding patent eligibility for diagnostic methods, as seen in previous rulings where CareDx's asserted patents were found invalid under Section 101, presents an ongoing risk to the value and enforceability of its intellectual property. Additionally, the company has faced securities fraud class actions alleging improper and illegal inflation of testing services revenue, which could lead to further regulatory scrutiny.

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Natera's Prospera test presents a clear emerging threat to CareDx. Prospera is a cell-free DNA (cfDNA) test for kidney transplant rejection that directly competes with CareDx's flagship AlloSure Kidney product. Natera, a well-established and well-funded diagnostics company, has been aggressively marketing Prospera and has gained significant market share in the transplant monitoring space, directly challenging CareDx's dominant position. This head-to-head competition from a capable rival offering a similar technology at a potentially competitive price point threatens to erode CareDx's revenue and market leadership in its core business, akin to how the iPhone disrupted BlackBerry's market.

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• Kidney Transplant Diagnostics (AlloSure Kidney, HistoMap Kidney): The kidney segment represented the largest revenue share in the global organ transplantation market in 2022. Approximately 42,000 kidney transplants occur annually in the United States. CareDx's AlloSure Kidney is a leading donor-derived cell-free DNA (dd-cfDNA) test for identifying kidney injury. HistoMap Kidney, a tissue-based molecular test, is expected to be available early 2026 through a clinical study.
• Heart Transplant Diagnostics (AlloMap Heart, AlloSure Heart, HeartCare): CareDx's AlloMap Heart, a gene expression profiling test, is utilized by over 90% of U.S. heart transplant centers. The company has delivered over 200,000 AlloMap or AlloSure results for more than 30,000 heart transplant recipients. HeartCare, which integrates AlloMap and AlloSure for heart transplant patients, received Medicare coverage in August 2023.
• Lung Transplant Diagnostics (AlloSure Lung): AlloSure Lung, a dd-cfDNA solution for lung transplant patients, received Medicare coverage in 2023. In the fourth quarter of 2022, approximately 2,300 AlloSure Lung tests were performed.
• Liver Transplant Diagnostics (LiverCare platform, including AlloSure Liver, AlloMap Liver, AlloHeme Liver, HistoMap Liver, AlloID): The global liver transplantation market is projected to reach US$ 1,901.0 million in 2025 and grow to US$ 3,010.1 million by 2032, with a CAGR of 6.8%. North America held a significant market share in liver transplantation in 2023, valued at over US$ 0.3 billion. In 2023, the United States saw a record 10,660 liver transplants. CareDx initiated a multi-center study for its LiverCare platform in 2021.
• HLA Typing Solutions (AlloSeq Tx17, QTYPE): Null
• Digital Transplant Solutions (Ottr, XynManagement, AlloCare app, CareDx Pro platform): Over 70% of transplant centers utilize at least one of CareDx's digital solutions.
• Pharma Services: Null

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Share Repurchases

• CareDx completed a $50 million share repurchase in the first quarter of 2025, representing approximately 5% of its outstanding shares.
• Following this, the Board of Directors authorized a new share repurchase program of up to $50 million over the subsequent 24 months.
• In the third quarter of 2025, CareDx repurchased an additional 2 million shares for $25.6 million, bringing the year-to-date 2025 repurchases to approximately 9% of outstanding shares.

Share Issuance

• Stock-based compensation, which contributes to share issuance, amounted to $66 million in 2024, $49 million in 2023, and $47 million in 2022.
• In 2021, stock-based compensation was $36 million, and in 2020, it was $23 million.
• The number of common stock shares outstanding increased from 51,503,377 at December 31, 2023, to 51,782,612 at March 31, 2024.

Capital Expenditures

• CareDx's projected capital expenditures are $19 million for 2025, $21 million for 2026, and $23 million for 2027.
• Projections continue with $27 million for 2028 and $30 million for 2029.
• Purchases of property and equipment, a component of capital expenditures, were approximately $8.137 million for the nine months ended September 30, 2022, and approximately $8.011 million for the nine months ended September 30, 2021.