Growing body of evidence supports AlloSure® as a clinical endpoint for risk assessment, treatment response, and long-term graft outcomes

Data across kidney, heart, lung, and multi-organ transplantation; featuring new KOAR prognostic findings and ImmuneScape™ single cell and spatial transcriptomics rejection classification advances

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 its participation at the American Transplant Congress (ATC) 2026, taking place June 20–24 in Boston, Massachusetts.

Real-world clinical use and scientific advancements involving AlloSure® Kidney, AlloSure Plus, HistoMap® Kidney, HeartCare® (AlloMap® Heart and AlloSure® Heart), and AlloSure® Lung will be featured in more than 30 abstracts and 9 oral presentations that include data generated from studies at over 110 transplant centers across the United States. The data reflect the continued evolution of AlloSure dd-cfDNA from an emerging biomarker to a potential clinical endpoint, with studies now utilizing AlloSure to assess allograft injury, monitor treatment response, and evaluate long-term graft health in kidney transplantation.

"The data at ATC reflect a clear shift: AlloSure is evolving beyond its established role in transplant surveillance — it is being explored as a clinical endpoint to evaluate treatment response, stratify risk, and predict graft outcomes," said Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx. "That has meaningful implications for how clinicians manage patients and how the field designs the next generation of clinical trials. At the same time, our ongoing work with techniques like spatial transcriptomics is providing novel insights into immune activation and injury in transplantation."

Key Study Findings in Kidney Transplantation:

• Persistent elevation of AlloSure in the first four months after kidney transplantation was associated with higher rates of rejection, de novo DSA, eGFR decline, and graft loss at three years, while transient elevations that normalized showed outcomes comparable to consistently low levels — supporting the prognostic value of early AlloSure monitoring. (Abstract 1332)
• In a single-center prospective study of tocilizumab for antibody-mediated rejection, AlloSure levels remained elevated over 12 months despite reductions in DSA and stabilization of eGFR, correlating with persistent histologic AMR on follow-up biopsy — supporting AlloSure as a sensitive marker of ongoing graft injury and treatment response. (Abstract 574)
• In a multicenter analysis of more than 4,000 kidney transplant recipients across 28 centers, elevated AlloSure was independently associated with MVI phenotypes, including DSA-negative, C4d-negative MVI, highlighting its role as a non-invasive marker of active alloimmune injury beyond conventional antibody-mediated rejection classifications. (Abstract 1334)
• AlloSure Plus scores were significantly higher in biopsy-confirmed ACR and AMR compared to no rejection, with an AUROC of 0.79 for discriminating rejection, supporting precision risk stratification beyond dd-cfDNA alone. (Abstract D075)

Next-Generation Biomarker Discovery:

• HistoMap Kidney molecular analysis classified the majority of biopsies with isolated arteritis (v-lesions) as "No Rejection," suggesting that isolated arteritis may not represent active T-cell-mediated rejection and supporting the use of molecular diagnostics to refine rejection diagnosis and guide treatment decisions. (Abstract C367)
• Integration of single-cell and spatial transcriptomics as part of ImmuneScape™ revealed distinct immune cell populations and spatial immune infiltration patterns associated with kidney allograft rejection, providing a framework for the discovery of novel biomarkers, improved molecular rejection classification, and future precision therapies. (Abstract C059)

Key Study Findings in Heart Transplantation:

• In heart transplantation, higher AlloMap scores were significantly associated with subsequent elevations in AlloSure Heart, with risk increasing at GEP scores ≥25 — supporting AlloMap as an early indicator of immune activation that may precede graft injury detected by dd-cfDNA alone. (Abstract 790)
• Patients initiated on mammalian target of rapamycin inhibitor (mTORi) initiation have increased evidence of molecular rejection as detected by HeartCare. More frequent non-invasive monitoring to detect early changes in immune activation and graft injury may be warranted in this population. (Abstract 793)

New Study Finding in Multiorgan Transplantation:

• HeartCare was routinely incorporated in post-transplant follow-up for simultaneous heart-kidney transplant recipients, with consistent testing frequency the investigators demonstrated predictable patterns in molecular testing results. (Abstract C365)

CareDx Symposia

A panel of esteemed transplant nephrologists will discuss the application of AlloSure Kidney and AlloSure Plus rejection risk assessment in clinical decision-making and patient management during an interactive case-based symposium sponsored by CareDx, featuring data from the recently-published second manuscript of KOAR.

• From Signal to Strategy: Translating AlloSure Molecular Insights Into Confident Clinical Decisions
  
  June 21, 2026, 12:15 p.m. – 1:15 p.m. PDT, Room 210BC
  
  Moderator: David Wojciechowski, DO, UT Southwestern
  Panelists: John J. Friedewald, MD, FASN, Northwestern Medicine; Nicole Ali, MD, NYU Langone; Nicolae Leca, MD, University of Washington; Deirdre Sawinski, MD, Weill Cornell Medicine.

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, AlloMap, HeartCare, AlloSure Plus, HistoMap, and ImmuneScape. 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, AlloMap, HeartCare, AlloSure Plus, HistoMap, and ImmuneScape are, risks that the findings in the SHORE and KOAR studies supporting the data may be inaccurate, 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.

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Source: CareDx, Inc.