Market leadership and solution selling: CareDx said it supports more than 200 transplant centers (~80% of US centers), has performed more than 1 million tests, and sees centers using three or more solutions generating about twice the test volume and revenue of other customers, leveraging diagnostics, HLA kits, pharmacy services and software.
2025 Consolidated Results and Balance Sheet: Full-year 2025 revenue of $380 million (up 14%) with 200,000 tests, Q4 revenue of $108 million (up 25%), adjusted EBITDA of $32 million, $201 million in cash, no debt, and $88 million in share buybacks.
Transplant + / AlloHeme Roadmap and Directions to 2026: CareDx targets Transplant+ as ~$$$$ repeat testing market with AlloHeme 41 days ahead showing clinical discovery and CLIA readiness/release timeline in 2026, commercial launch and coverage submission in 2027 and Medicare coverage/revenue share in 2820; 2026 guidance is $420–444 million in revenue, $220k–228k in revenue, and $30–45 million in 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 Institute Investor Conference. Chief Operating Officer and recently appointed Chief Financial Officer Keith Kennedy and Chief Commercial Officer Jessica Meng described CareDx’s position in robust organ transplant diagnostics and services, and provided additional details on the company’s pipeline plans under the “Transplant+” roadmap.
Kennedy reiterated CareDx’s stated vision that “every patient receives the transplant they need to live a long, full life,” and explained the clinical conditions that drive ongoing calls for monitoring. There are about 100,000 patients on the US transplant waiting list and a new patient is added every 8 to 10 minutes, he said. After solid organ transplantation, patients are monitored regularly—often monthly or quarterly—for early signs of rejection, when intervention is most likely to preserve graft function.
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CareDx has described itself as the market leader in solid organ transplants, saying it will perform more than 1 million tests and nearly 200,000 tests by 2025. The company said it supports more than 200 transplant centers in the United States, representing approximately 80% of all transplant centers, and provides patient-centered testing services, software, and testing solutions. Kidney, liver, heart, lung and multi-organ transplants.
More than 200,000 next-generation sequencing-based HLA typing kits are sold annually, offered in 100 countries
A transplant-focused pharmacy business serving patients in all 50 states, filling more than 150,000 transplant prescriptions annually
Software products that support 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 identify damage to a transplanted organ and assess the risk of rejection. He said high donor-derived cell-free DNA may indicate potential graft injury or rejection, and AlloSure is the first clinically validated and commercially available donor-derived cell-free DNA test routinely used throughout solid organ transplantation.
CareDx reviewed its AlloSure product launches, including AlloSure Kidney (2017), HeartCare (2018), AlloSure Heart (2020), and AlloSure Lung (2021). Centers have adopted AlloSure as part of routine monitoring protocols, with widespread use of AlloSure kidney in causal settings such as monitoring during changes in immunosuppression, Kennedy said.
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Both executives emphasized a “solution selling” approach. Kennedy said CareDx analysis shows that centers using three or more company solutions generate double the test volume and revenue of other customers, with more than 50% patient acquisition, without requiring a commensurate increase in sales and marketing resources. Meng added that the concentrated nature of the transplant market allows CareDx to leverage existing business infrastructure across a relatively small number of centers and clinics, with increased revenue directly contributing to profitability.
Kennedy reviewed the financial results previously discussed for the company’s fiscal year. For the fourth quarter of 2025, CareDx reported total revenue of $108 million, up 25% year over year, with test volume of 53,000 tests, a 17% increase. Non-GAAP gross margin was 69% (reported as 68.5% for the quarter in the financial statements). Adjusted EBITDA was $6.5 million and included about $7 million in one-time cash bonuses paid in lieu of equity awards to non-executives, which Kennedy said was consistent with the 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 $275 million, up 10%, volume of nearly 200,000 tests (up 14%)
Patient Digital Solutions revenue was $57 million, up 31%
Laboratory products revenue was $48 million, an increase of 19%
Non-GAAP gross profit for the year was $263 million with a gross margin of 69%, in line with last year. Adjusted EBITDA was $32 million, up 14% year over year, and Kennedy said that would have been absent a 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 mentioned raising cash and working capital. He said 2025 cash collections totaled $406 million, an increase of 32%, helped by a $23 million decrease in accounts receivable and a reduction in the period from 71 days to 41 days from 4Q4. CareDx repurchased $88 million of common stock during the year, buying 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 development, market access, and evidence generation. In go-to-market initiatives, he highlighted efforts to reduce configuration friction through Epic integration and lab system changes. Between 80% and 85% of transplant centers use Epic as their primary electronic medical record, and CareDx is dually integrated with about 40% of those centers, Kennedy said.
He said seven transplant centers are live in Epic Aura, with 14 more centers being actively implemented. Kennedy cited early benefits including improved electronic layout and data quality and a 40% reduction in login-related issues, and said early live sites showed increased performance after going live. CareDx is also migrating its lab information management system to Epic Enterprise, which the company said supports faster product launches and more seamless data exchange while protecting results and billing timelines.
In producing evidence, Kennedy cited publications of the Registry including KOAR, SHORE, and ALAMO; Scientific abstracts such as ImmuneScape; and intervention trials including MERIT and HARBOR. He also discussed the company’s ImmuneScape program and the 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 advances.
Kennedy said CareDx introduced the “Transplant+” roadmap at its October 2024 investor day as a way to expand beyond solid organ transplants. He described AlloHeme as the company’s first Transplant+ solution and entry into the cell therapy market, providing it as an extension of CareDx’s experience in long-term monitoring.
According to Kennedy, in relapsed patients with allohem positive results, the test identified a median relapse rate 41 days before clinical detection. CareDx sizes Transplant+ as a $1 billion repeat testing market opportunity and said hematopoietic stem cell transplant patients may be followed up and tested up to 14 times in the 24 months after transplant. The company anticipates targeted timelines for CLIA preparation and dissemination activities in 2026, commercial launch and delivery of coverage in 2027, and Medicare coverage and revenue share in 2028.
In a Q&A, Meng said Allo Heme will target heme oncologists and highlight the estimated concentration of about 200 bone marrow transplant centers. She also said that CareDx hopes to leverage existing business capabilities, such as marketing and market access, with AI capabilities, and noted that some of CareDx’s software solutions have already been implemented in bone marrow transplant centers.
For 2026, CareDx guided for revenue of $420 million to $444 million, representing about 14% growth at the midpoint. The company guided for testing services revenue of $306 million to $326 million and test volume of 220,000 to 228,000 tests. Kennedy said the guidance assumes the LCD draft is finalized as detailed and implemented by mid-year, estimating a full-year revenue (and adjusted EBITDA) impact of $15 million, with an annualized impact of $7.5 million included in the 2026 revenue guidance. CareDx also expects to report off-period revenue of $5 million 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 company develops and commercializes noninvasive tests designed to detect organ transplant rejection and risk of infection, helping physicians make informed management decisions during 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, 2026 Outline, and 2026 Outlook at Raymond James Conference” was originally published by MarketBeat.
