CareDx Highlights 39% Q1 Growth, Naveris Oncology Push at Jefferies

Key Points

• CareDx posted strong Q1 results, with revenue up 39% year over year and Testing Services volume up 17%. The company also raised full-year guidance, projecting revenue of $447 million to $465 million and adjusted EBITDA of $43 million to $57 million.
• The Naveris acquisition expands CareDx into oncology, adding a viral-mediated cancer MRD platform with Medicare coverage in key indications and more than 130,000 tests performed. CareDx expects Naveris to grow 30% to 40% annually over the next three years and be EBITDA-neutral in 2026.
• CareDx is building a broader pipeline across transplant and oncology, with AlloHeme as its top priority, plus AlloSure Liver and HistoMap Kidney in development. Management said the expanded portfolio lifts its total addressable market to $12.5 billion.

CareDx NASDAQ: CDNA executives outlined the company’s growth strategy, first-quarter performance and pipeline priorities during a presentation at the Jefferies Healthcare Conference, emphasizing transplant diagnostics, specialty oncology and digital workflow integration.

John Hanna, chief executive officer of CareDx, said the company is focused on markets where it believes it can hold leading positions, particularly areas involving high-cost diseases, concentrated specialist providers and repeat testing. He said CareDx has about 750 employees, including roughly 200 focused on customers and patients, 110 scientists and researchers and about 80 software programmers.

Hanna said CareDx has spent 25 years bringing innovations to the transplant market and currently serves more than 200 solid organ transplant programs in the U.S. He said the company has performed more than 1 million molecular tests to monitor for organ rejection, while 70% of transplant centers use at least one of its digital solutions. CareDx also filled more than 200,000 prescriptions last year for transplant patients, primarily related to immunotherapy and other products.

First-Quarter Growth and Updated Guidance

CareDx reported 39% year-over-year revenue growth in the first quarter, with Testing Services volume up 17%. Hanna said adjusted EBITDA was $18.9 million for the quarter, and the company ended the period with approximately $189 million in cash and cash equivalents and no debt.

By segment, Hanna said Testing Services revenue grew 48% year-over-year, Patient and Digital Services revenue increased 33%, and Lab Products revenue declined 4%. He attributed the Lab Products decline mainly to stocking orders pulled forward into the fourth quarter.

Following the quarter, CareDx updated its full-year outlook to:

• Revenue of $447 million to $465 million
• Adjusted EBITDA of $43 million to $57 million
• Testing Services volume of 224,000 to 229,000 tests
• Non-GAAP gross margin of 68% to 71% per quarter
• Non-GAAP operating expenses of $68 million to $70 million per quarter

Keith Kennedy, CareDx’s chief financial officer and chief operating officer, said recent growth has been supported by improvements in reimbursement and revenue cycle management. He also pointed to clinical evidence, including the company’s SHORE and KOAR publications, as contributing to adoption and volume growth in transplant centers.

Kennedy said the company’s margin profile benefits from scale and long-term agreements, including its relationship with Illumina. He said CareDx believes its margins are stable “in the 70% range.”

Digital Workflow Integration

CareDx executives also highlighted the role of digital tools in supporting adoption. Kennedy discussed the company’s VANTx AI-powered analytics platform, saying it helps physicians and patients understand population management. He said CareDx is also transforming internal systems so company leaders have real-time information to operate the business.

Kennedy said CareDx worked with Epic to support ordering and workflow integration for transplant centers. He said the goal was to provide physicians with easier ordering, use and access to CareDx tests through the Epic interface.

Naveris Acquisition Expands Oncology Focus

Hanna discussed CareDx’s acquisition of Naveris, which he described as a leading solid tumor minimal residual disease platform for viral-mediated cancers. He said the business fits CareDx’s strategy because it is reimbursed, growing rapidly and focused on tumor-naive MRD testing for cancers including head and neck cancer, anal cancer and gynecologic malignancies.

According to Hanna, Naveris has performed more than 130,000 tests and has Medicare coverage for MRD in head and neck and anal cancer. He said the company has about 100 employees in the U.S., an $1,800 Medicare reimbursement rate and approximately 100 million covered lives. Hanna said Naveris generated about $34 million in revenue in 2025 and that CareDx expects the business to grow 30% to 40% year-over-year for the next three years.

Hanna said the Naveris test has greater than 95% positive predictive value and negative predictive value for HPV-positive head and neck cancer, with published literature showing an approximately four-month lead time to detect recurrence. He said the technology is covered by five patents related to proprietary detection methods in viral-mediated cancers.

Hanna said CareDx plans to use its commercial infrastructure, marketing organization, patient engagement resources, mobile phlebotomy network and Epic integration work to help accelerate Naveris adoption. He said CareDx can add the Naveris order set into its Epic Aura instance to support ordering through Epic interfaces.

Kennedy said the company expects the Naveris business to be neutral to EBITDA in 2026. He said integration priorities include supporting Naveris employees, aligning commercial strategy, integrating accounting and cybersecurity functions and continuing to operate the lab without interruption.

Pipeline Priorities: AlloHeme, Liver and Kidney

Hanna said CareDx’s key pipeline initiatives include AlloHeme for hematologic oncology, AlloSure Liver for solid organ transplant and HistoMap Kidney, a tissue-based product intended to complement the company’s blood-based AlloSure assay.

Hanna described AlloHeme as the company’s top pipeline priority. The test is designed for AML and MDS patients after hematopoietic stem cell transplant, monitoring for relapse in a setting Hanna said is not served by existing MRD solutions. He said CareDx’s goal for 2026 is to publish the manuscript from the ACROBAT trial, complete analytical verification work, submit for New York State approval and seek coverage, with a more meaningful commercial effort expected in early 2027. He said coverage could likely come in 2028.

For AlloSure Liver, Hanna said the company is still completing the clinical validation trial and has not provided a commercialization timeline. He said CareDx expects to share more later this year as it determines the right indication and use case.

Hanna also highlighted HistoMap Kidney, saying the company has invested significantly in the product and has one manuscript in press, with another forthcoming. He said the test is intended to provide gene-expression-based subtyping after kidney biopsy when histology is inconclusive.

With Naveris added to its portfolio, Hanna said CareDx now has a multi-indication offering spanning solid organ transplantation, specialty oncology, hematology and cell therapy monitoring. He said the acquisition expands the company’s total addressable market to $12.5 billion across solid organ transplantation, digital and patient solutions, cell therapy and hematology, and viral-mediated cancers.

About CareDx NASDAQ: CDNA

CareDx, Inc NASDAQ: CDNA is a precision diagnostics company focused on the care of transplant patients. The firm develops and commercializes non‐invasive tests designed to detect organ transplant rejection and infection risk, helping physicians make informed management decisions throughout the post‐transplant journey.

The company's core product portfolio includes AlloMap®, a gene expression profiling test for heart transplant recipients, and AlloSure®, a donor‐derived cell‐free DNA assay used primarily in kidney transplant monitoring.

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