CareDx Details Transplant+ Roadmap, AlloHeme Timeline, and 2026 Outlook at Raymond James Conference

• Market leadership and solution selling: CareDx said it supports more than 200 transplant centers (~80% of U.S. centers), has performed over 1 million tests, and sees centers using three or more solutions generate roughly twice the testing volume and revenue versus other customers, leveraging diagnostics, HLA kits, pharmacy services and software.

• Strong 2025 results and balance sheet: Full-year 2025 revenue was $380 million (up 14%) with ~200,000 tests, Q4 revenue was $108 million (up 25%), adjusted EBITDA $32 million, $201 million in cash, no debt, and $88 million of share repurchases.

• Transplant+ / AlloHeme roadmap and 2026 guidance: CareDx targets Transplant+ as a ~$1 billion repeat-testing market with AlloHeme showing median relapse detection 41 days before clinical detection and a timeline of CLIA readiness/publication in 2026, commercial launch and coverage submission in 2027 and Medicare coverage/revenue contribution in 2028; 2026 guidance is $420–444 million revenue, 220k–228k tests, and $30–45 million adjusted EBITDA.

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CareDx (NASDAQ:CDNA) executives outlined the company’s transplant-focused strategy, recent financial performance, and 2026 priorities during remarks at the Raymond James Institutional Investor Conference. Chief Operating Officer and recently appointed Chief Financial Officer Keith Kennedy and Chief Commercial Officer Jessica Meng described CareDx’s position in solid organ transplant diagnostics and services, and provided additional detail around pipeline plans under the company’s “Transplant+” roadmap.

Kennedy reiterated CareDx’s stated vision that “every patient receives the transplant they need to live longer, fuller lives,” and described the clinical context driving ongoing demand for monitoring. He said there are approximately 100,000 patients on the U.S. transplant waiting list and that a new patient is added every 8 to 10 minutes. Following solid organ transplant, patients are monitored regularly—often monthly or quarterly—for early signs of rejection, when intervention is more likely to preserve graft function.

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CareDx described itself as the market leader in solid organ transplantation, stating it has performed more than 1 million tests and approximately 200,000 tests in 2025. The company said it supports more than 200 transplant centers in the U.S., representing roughly 80% of all transplant centers, and offers testing services, software, patient solutions, and distributed test kits across kidney, liver, heart, lung, and multi-organ transplants.

Kennedy highlighted CareDx’s broader footprint beyond diagnostics, including:

• More than 200,000 next-generation sequencing-based HLA typing kits sold annually, offered in over 100 countries

• A transplant-focused pharmacy business serving patients in all 50 states, with more than 150,000 transplant prescriptions filled annually

• Software products supporting medication adherence management and quality reporting, which the company said are integrated into clinical workflows at transplant centers

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Kennedy described AlloSure as a non-invasive blood test that measures donor-derived cell-free DNA to detect injury to the transplanted organ and assess rejection risk. He said elevated donor-derived cell-free DNA may indicate potential graft injury or rejection, and positioned AlloSure as the first clinically validated and commercially scaled donor-derived cell-free DNA test used routinely across solid organ transplants.

CareDx reviewed its AlloSure product launches, including AlloSure Kidney (2017), HeartCare (2018), AlloSure Heart (2020), and AlloSure Lung (2021). Kennedy said centers have adopted AlloSure as part of regular surveillance protocols, with expanded use of AlloSure Kidney in for-cause settings such as monitoring during changes in immunosuppression.

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Both executives emphasized a “solution selling” approach. Kennedy said CareDx’s analysis shows centers using three or more company solutions generate about twice the testing volume and revenue compared to other customers, along with more than 50% higher patient acquisition, without requiring a proportional increase in sales and marketing resources. Meng added that the concentrated nature of the transplant market allows CareDx to leverage an existing commercial infrastructure across a relatively small number of centers and clinicians, with incremental revenue contributing more directly to profitability.

Kennedy reviewed financial results previously discussed on the company’s earnings call. For the fourth quarter of 2025, CareDx reported total revenue of $108 million, up 25% year-over-year, with testing volume of 53,000 tests, up 17%. Non-GAAP gross margin was 69% (reported as 68.5% for the quarter in the financial detail). Adjusted EBITDA was $6.5 million and included roughly $7 million in one-time cash bonuses paid in lieu of equity awards for non-executives, which Kennedy said was aligned with a focus on managing shareholder dilution.

For the full year 2025, CareDx reported revenue of $380 million, up 14% year-over-year, including:

• Testing services revenue of $275 million, up 10%, on volume of approximately 200,000 tests (up 14%)

• Patient digital solutions revenue of $57 million, up 31%

• Lab products revenue of $48 million, up 19%

Non-GAAP gross profit for the year was $263 million with a 69% gross margin, consistent with the prior year. Adjusted EBITDA was $32 million, up 14% year-over-year, and Kennedy said it would have been higher absent the one-time cash bonus. The company ended 2025 with $201 million in cash and cash equivalents, 50.9 million shares outstanding, and no debt.

Kennedy also pointed to improvements in cash collections and working capital. He said 2025 cash collections totaled $406 million, up 32%, contributing to a $23 million reduction in accounts receivable and a decrease in days sales outstanding from 71 days to 41 days on a Q4-over-Q4 basis. CareDx repurchased $88 million of common stock during the year, acquiring 5.8 million shares at an average price of $15.16 per share, and repurchased $12 million in Q4.

Looking ahead, Kennedy said CareDx’s 2026 growth drivers are pipeline advancement, go-to-market execution, and evidence generation. On go-to-market initiatives, he highlighted efforts to reduce ordering friction through Epic integrations and lab system changes. Kennedy said 80% to 85% of transplant centers use Epic as their core electronic medical record, and CareDx is bilaterally integrated with about 40% of those centers.

He said seven transplant centers are live on Epic Aura, with 14 additional centers in active implementation. Kennedy cited early benefits including improved electronic ordering and data quality and a 40% reduction in login-related issues, and said early live sites are showing increased activity post go-live. CareDx is also migrating its laboratory information management system to Epic Enterprise, which the company said would support faster product launches and more seamless data exchange while protecting results and billing timelines.

On evidence generation, Kennedy referenced registry publications including KOAR, SHORE, and ALAMO; scientific abstracts such as ImmuneScape; and interventional trials including MERIT and HARBOR. He also discussed the company’s ImmuneScape program and a collaboration with 10x Genomics announced in January, describing it as leveraging multiomics, single-cell, and spatial biology technologies to generate insights that could inform future diagnostic development.

Kennedy said CareDx introduced its “Transplant+” roadmap at an October 2024 Investor Day as a path to extend beyond solid organ transplant. He described AlloHeme as the company’s first Transplant+ solution and its entry into the cell therapy market, framing it as an extension of CareDx’s experience in longitudinal monitoring.

According to Kennedy, among relapse patients with AlloHeme-positive results, the test identified relapse a median of 41 days before clinical detection. CareDx sized Transplant+ as a $1 billion repeat-testing market opportunity and said hematopoietic stem cell transplant patients may be followed and tested up to 14 times over 24 months post-transplant. The company outlined a targeted timeline of CLIA readiness and publication activities in 2026, commercial launch and coverage submission in 2027, and estimated Medicare coverage and revenue contribution in 2028.

In the Q&A, Meng said AlloHeme will target hem-oncologists and highlighted an estimated concentration of roughly 200 bone marrow transplant centers. She also said CareDx expects to leverage existing commercial capabilities such as marketing and market access, along with AI capabilities, and noted that certain CareDx software solutions are already implemented in bone marrow transplant centers.

For 2026, CareDx guided to revenue of $420 million to $444 million, representing about 14% growth at the midpoint. The company guided testing services revenue of $306 million to $326 million and testing volume of 220,000 to 228,000 tests. Kennedy said the guidance assumes a draft LCD is finalized as outlined and implemented mid-year, estimating a full-year impact of $15 million in revenue (and Adjusted EBITDA), with $7.5 million of the annual impact included in the 2026 revenue guidance. CareDx also expects to report $5 million in out-of-period revenue in the first half of 2026. Adjusted EBITDA guidance for 2026 was $30 million to $45 million.

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.

The article “CareDx Details Transplant+ Roadmap, AlloHeme Timeline, and 2026 Outlook at Raymond James Conference” was originally published by MarketBeat.