CareDx Announces Second KOAR Analysis Published in the Journal of the American Society of Nephrology

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.

dd-cfdna medical

Donor-derived cell-free DNA (dd-cfDNA) are tiny fragments of DNA from a transplanted organ that float in the blood of the recipient; testing measures how much of the free DNA comes from the donor. Like finding fresh crumbs that reveal whether something has been disturbed, higher levels can indicate organ injury or rejection before symptoms appear, so investors watch adoption of these noninvasive tests because they can change follow-up care, reduce costly biopsies, and drive demand for new diagnostics and monitoring services.

allograft medical

Tissue taken from one person and transplanted into another to repair or replace damaged body parts, such as bone, skin, or heart valves. For investors, allografts matter because their use involves manufacturing standards, supply and safety controls, regulatory approvals, and reimbursement rules that can affect sales, liability and growth for companies that process, store or sell these biological materials — similar to how sourcing and quality control of key parts affect a manufacturer’s business.

graft loss medical

Graft loss is the failure or loss of function of a transplanted organ, tissue, or engineered biological material so that it no longer performs its intended job — like a replacement part that stops working. For investors, graft loss is a key clinical and regulatory outcome because it affects patient survival and quality of life, shapes the results and approval chances of therapies or devices, and influences market demand, treatment costs, and liability risk.

biomarker medical

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

multistate modeling framework technical

A multistate modeling framework is a statistical tool that maps how subjects move between defined health or event stages (for example: healthy, ill, recovered, or deceased) over time and estimates the chances and timing of each transition. Like a roadmap showing different routes and how long each trip takes, it helps investors translate trial results or patient pathways into likely future outcomes, costs, and commercial or regulatory milestones that affect a company’s value.

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AlloSure^® Kidney elevations are associated with increased risk of graft dysfunction and loss in kidney transplant recipients

Data support the role of AlloSure^® Kidney as a noninvasive tool for longitudinal risk stratification and clinical decision-making

BRISBANE, Calif.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260616081611/en/

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

Investor Relations
Caroline Corner
investor@CareDx.com

Source: CareDx, Inc.