CareDx Announces Third KOAR Analysis Published in Transplantation

Early measurement patterns distinguished groups with different three-year outcomes in a cohort of 1,137 kidney transplant recipients.

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AlloSure® Kidney trajectories within the first four months post-transplant were associated with three-year graft outcomes

BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) — a leading precision medicine diagnostics company in transplant, specialty oncology, and cell therapy, today announced the publication of a new analysis from the Kidney Allograft Outcomes AlloSure Registry (KOAR), a landmark multicenter study, in the journal Transplantation.

The third manuscript from KOAR investigated the correlation between early post-transplant AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA) levels and three-year kidney allograft outcomes in a multicenter cohort of 1,137 kidney transplant recipients across 56 centers. Recipients were categorized into trajectory groups based on AlloSure Kidney measurements obtained within the first four months post-transplant: consistently low, transient-elevation, late-elevation, and persistent-elevation. Multivariable models were applied to evaluate association between early AlloSure Kidney trajectory groups and subsequent 3-year outcomes, including allograft dysfunction and graft loss. Rates of delayed graft function were similar across all groups, suggesting that perioperative injury alone did not explain early AlloSure Kidney elevations. Taken together, these findings support the clinical interpretability of AlloSure Kidney during the early post-transplant period.

“Early elevations in dd-cfDNA have often been attributed to perioperative injury, leaving uncertainty about their long-term clinical significance,” said Dr. Kalathil Sureshkumar, MD, FRCP, FASN, Division of Nephrology and Hypertension, Medicine Institute, Allegheny General Hospital. “Our findings show that the pattern of dd-cfDNA changes during the first four months after transplantation can predict long-term graft outcomes. Persistent or later-emerging elevations can identify patients at substantially higher risk of rejection and graft loss, while transient elevations that resolve are associated with more favorable outcomes. These findings reinforce the value of routine early monitoring to help clinicians identify patients who may benefit from closer surveillance.”

Key findings include:

• Patients with persistent AlloSure Kidney elevation during the first four months post-transplant had a nine-fold higher incidence of allograft loss compared with patients with consistently low AlloSure Kidney.
• Late AlloSure Kidney elevation within the first four months post-transplant was independently associated with donor-specific antibody development, rejection, and allograft loss, with graft loss occurring in 8.8% of patients in this group.
• Transient elevations in AlloSure Kidney that resolved within the first 4 months post-transplant were not associated with worse outcomes, sharing similar incidence to recipients with consistently low AlloSure Kidney (2.9% vs. 2.2%, respectively).
• Most recipients (83.7%) had consistently low AlloSure Kidney levels during the first four months post-transplant and experienced favorable three-year outcomes, including low rates of graft dysfunction and graft loss.
• Baseline graft function was similar across all groups, suggesting that AlloSure Kidney elevations may identify molecular injury before clinical graft dysfunction becomes evident.

“The robust evidence provided by the KOAR registry continues to demonstrate the utility of AlloSure Kidney across clinical contexts and throughout the post-transplant course,” said Jeffrey Teuteberg, MD, Chief Medical Officer of CareDx. “The routine use of AlloSure Kidney can help clinicians identify which patients early post-transplant may be at higher risk for poor outcomes and support development of personalized care strategies for these patients.”

The full publication is available online at: https://www.ovid.com/jnls/transplantjournal/fulltext/10.1097/tp.0000000000005959~prognostic-significance-of-early-donor-derived-cell-free-dna

About CareDx

CareDx is a leading precision medicine diagnostics company advancing care in transplant, specialty oncology, and cell therapy. Through non-invasive longitudinal molecular biomarker testing, digital health, and patient support solutions, CareDx is dedicated to improving patient outcomes. For more information, please visit www.caredx.com.

Forward-Looking Statements

This press release includes forward-looking statements related to CareDx including statements regarding the potential benefits and results that may be achieved with AlloSure Kidney. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure Kidney, risks that the findings in the study described herein may be inaccurate or may not be replicated, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

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CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com

Investor Relations
Nina Deka
investor@CareDx.com

Source: CareDx, Inc.

Key Terms

donor-derived cell-free DNA medical

Donor-derived cell-free DNA is fragments of DNA shed by a transplanted organ into the recipient’s bloodstream. Measuring its level is like checking a smoke alarm: rising amounts can warn of organ injury or immune rejection before symptoms appear. Investors track this biomarker because tests and treatments that detect or lower it can change clinical decisions, demand for diagnostic services, and the economic outlook for transplant-related healthcare products.

allograft dysfunction medical

Allograft dysfunction is impaired function of a transplanted organ or tissue (the allograft) from a genetically non‑identical donor. It describes any decline in the graft’s performance caused by processes such as immune rejection (acute or chronic), infection, ischemia or technical problems, and is identified by clinical signs, laboratory tests, imaging or biopsy rather than by the mere presence of a transplant. The term denotes the functional problem itself and does not imply a single cause—diagnosis requires further testing to determine whether dysfunction reflects rejection, injury, infection, recurrent disease or another mechanism.

donor-specific antibody medical

An antibody in a transplant recipient that specifically recognizes and binds antigens expressed by the donor’s cells—most commonly human leukocyte antigens (HLA). Donor-specific antibodies (DSAs) can be present before transplant or arise afterward (de novo); when they bind donor tissue they can trigger immune injury mechanisms such as complement activation and antibody-mediated rejection, though not every detected DSA causes clinical damage. Laboratory tests identify DSAs by measuring antibody binding to donor or donor-type antigens (often with bead-based HLA assays), and results must be interpreted in context because strength, complement-binding ability, and timing affect the clinical significance.

multivariable models technical

Statistical models that relate one outcome (dependent variable) to two or more predictor variables at the same time, estimating how each predictor is associated with the outcome while holding the others constant. They are used for prediction and to adjust for confounding in analyses; their results depend on model choice and assumptions (linearity, correct variable specification, no important omitted variables, and appropriate handling of interactions and collinearity) and show associations rather than proving causation.