CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers, today announced the publication of a new analysis from the Kidney Allograft Outcomes AlloSure Registry (KOAR), a landmark multi-center study, in the Journal of the American Society of Nephrology (JASN).
The second manuscript from KOAR evaluated the relationship between AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA) and three year kidney allograft outcomes in a multi-center cohort of 1,258 adult kidney transplant recipients across 56 U.S. centers. The study applied a multistate modeling framework to assess how longitudinal changes in AlloSure dd-cfDNA levels over time relate to subsequent allograft dysfunction and graft loss. During follow-up, approximately 36% of patients experienced dd-cfDNA elevation, transitioning from low to higher-risk states and underscoring the clinical relevance of longitudinal monitoring.
“This analysis from the KOAR registry shows that elevations in dd-cfDNA are associated with meaningful differences in long-term allograft outcomes,” said Jeffrey A. Klein, MD, Division of Nephrology, University of Kansas. “Importantly, we observed that many of these elevations occur while kidney function remains preserved, highlighting the potential for dd-cfDNA to provide earlier insight into allograft injury and help inform patient management.”
Key findings include:
- Transitions to elevated AlloSure levels were associated with a 3.7-fold and 6.4-fold higher adjusted hazards of allograft loss for intermediate and high states, respectively.
- Even a single elevation in AlloSure was associated with a measurable shift in clinical trajectory.
- Most AlloSure elevations occurred while kidney function remained preserved. demonstrating the ability to detect subclinical injury prior to measurable decline in eGFR.
- Patients with persistently low AlloSure levels experienced favorable outcomes, including low rates of rejection, dysfunction, and graft loss over three years.
“The KOAR registry continues to provide important real-world evidence on how dd-cfDNA can be used in clinical practice,” said Jonathan S. Bromberg, MD, PhD, Professor of Surgery, University of Maryland School of Medicine. “These findings suggest that tracking dd-cfDNA over time may offer a useful framework for risk stratification and longitudinal surveillance in kidney transplant recipients.”
“These results from KOAR extend the growing body of evidence supporting AlloSure dd-cfDNA as a clinically meaningful biomarker in kidney transplantation,” said Jeffrey Teuteberg, MD, Chief Medical Officer of CareDx. “By enabling earlier identification of changes in allograft status, AlloSure may help clinicians assess risk over time and support more personalized patient management.”
The full publication is available online at: https://journals.lww.com/jasn/fulltext/9900/elevations_in_donor_derived_cell_free_dna_and.1046.aspx
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non‑invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics‑based information for transplant patients. 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. 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 the risk that CareDx does not realize the expected benefits of AlloSure, the risk that the findings of the KOAR study may not be predictive of, or replicated in, broader clinical use, 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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