Company Announcements

Breadth of Data Demonstrates the Important Role of Precision Medicine Testing in Post-Transplant Monitoring and Decision Making

New SHORE Data Highlights Significance of Early Molecular Signals in Heart Transplant and New ALAMO Data Highlights Significance of Longitudinal Risk Assessment in Lung Transplantation

BRISBANE, Calif.--(BUSINESS WIRE)--Apr. 21, 2026-- 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 International Society of Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting, taking place April 22–25 in Toronto, Canada.

The real-world clinical use and scientific advancements involving HeartCare®, AlloSure® Heart, AlloMap® Heart, and AlloSure® Lung will be featured in 50 abstracts, 16 oral presentations, and two symposia that include data generated from studies at 95 transplant centers. The data reflect ongoing evidence generation supporting the role of CareDx’s non-invasive molecular testing in post-transplant surveillance, risk assessment, and longitudinal patient management in both heart and lung transplantation.

“What’s most compelling about the data being presented at ISHLT this year is the growing body of evidence across multiple, independent studies in both heart and lung transplantation, including findings from SHORE and ALAMO, to support the routine clinical use of non-invasive molecular testing,” said Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx. “We are seeing consistent signals that information from longitudinal molecular testing can provide early and impactful data to allow physicians to better manage their patients’ care. We are also extremely excited to introduce MERIT, our randomized controlled trial evaluating management strategies in heart transplant patients with abnormal molecular testing despite negative histology on biopsy.”

Key Study Findings in Heart Transplantation:

• Elevations in HeartCare (AlloMap Heart and AlloSure Heart) were observed months prior to acute cellular and antibody-mediated rejection. (Abstract 419)
• Greater use of HeartCare molecular testing was associated with fewer endomyocardial biopsies, with analyses linking fewer biopsies to a lower incidence of tricuspid regurgitation. (Abstract 870)
• Surveillance strategies relying more heavily on HeartCare molecular testing were associated with lower overall surveillance costs compared to biopsy-focused strategies, with no observed impact on survival. (Abstract 960)
• AlloSure Heart levels were elevated during acute rejection across all pediatric age ranges, supporting its role for rejection surveillance as a non-invasive marker of graft injury in pediatric heart transplant recipients. (Abstract 1535)

Key Study Findings in Lung Transplantation:

• Magnitude of change from personalized AlloSure Lung baseline was associated with increased risk of clinically significant lung function loss, with age-dependent differences noted in the analysis. (Abstract 1174)
• Within-patient changes in AlloSure Lung were inversely associated with spirometric measures of lung function, supporting AlloSure Lung as a dynamic indicator of injury burden linked to lung function over time. (Abstract 1167)
• Population-level AlloSure Lung kinetic patterns were associated with distinct spirometry trajectories following lung transplantation. (Abstract 1168)
• Increases in AlloSure Lung from individualized baselines in the ALAMO registry were associated with clinically significant loss-of-spirometric-function events, including acute and chronic lung allograft dysfunction. (Abstract 1169)
• An evaluation of fixed versus running baseline approaches to defining patient-specific AlloSure Lung reference values suggest that running baseline methods may provide better clinical utility than a fixed baseline. (Abstract 1176)

CareDx Symposia

A panel of esteemed professionals will discuss the application of HeartCare and AlloSure Lung in clinical decision-making and patient management during two interactive case-based symposia sponsored by CareDx.

• Beyond Histology: The MERIT of Molecular Phenotyping with HeartCare
  April 24, 2026, 11:45 a.m. – 12:45 p.m. ET, Room 718 A
  Moderator:Anne van Beuningen, MD, Emory University
  Panelists: Nir Y. Uriel, MD, NY Presbyterian/Columbia University; Yas Moayedi, MD, University Health Network; Snehal Patel, MD, Northwell Health

• From Signal to Action: Can AlloSure Lung Inform Earlier Intervention?
  April 23, 2026, 11:45 a.m. – 12:45 p.m. ET, Room 718 A
  Moderator: Steven Hays, MD, University of California, San Francisco
  Panelists: Hannah Mannem, MD, University of Virginia; Lorenzo Zaffiri, MD, Emory University; Cynthia J. Gries, MD, University of Florida

The SHORE Study

One of the largest heart transplant studies of its kind, SHORE (Surveillance HeartCare Outcomes Registry) is a prospective 67-center, observational study of over 2,700 heart transplant patients in the United States receiving non-invasive molecular testing with AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene expression profiling (GEP). Together as HeartCare, these different molecular tests offer a more comprehensive evaluation of a patient’s heart transplant status by assessing both allograft health and immune system activity. Findings from SHORE have been published in leading peer-reviewed journals, including the Journal of Heart and Lung Transplantation^1,2 and the Journal of the American College of Cardiology: Heart Failure³. Published analyses demonstrate the clinical utility of combined molecular testing for rejection surveillance, antibody-mediated rejection assessment, and prognostic risk stratification to inform post-transplant clinical decision-making.

The ALAMO Study

ALAMO (AlloSure Lung Assessment and Metagenomic Outcomes) is a prospective, multicenter, international observational registry evaluating AlloSure Lung dd-cfDNA surveillance in lung transplant recipients. The registry includes adult single and bilateral lung transplant patients followed longitudinally across U.S. and international transplant centers. Analyses from ALAMO have been presented and are now informing peer-reviewed publications, with findings supporting the clinical utility of individualized AlloSure Lung baselines and longitudinal molecular monitoring to assess allograft injury and lung function outcomes in routine post-transplant surveillance.

The MERIT Trial

MERIT (Molecular Evidence of Rejection Interventional Trial) is a prospective, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate management strategies in heart transplant recipients with abnormal non-invasive molecular testing despite negative histology on endomyocardial biopsy. The trial is designed to enroll stable adult heart transplant recipients with dual-positive molecular results from AlloMap Heart and AlloSure Heart between two months and two years post-transplant and assesses whether treatment guided by molecular findings can improve clinical outcomes compared with standard management.

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, and HeartCare. 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, and HeartCare are, risks that the findings in the SHORE and ALAMO 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.

References

1. Hall S, Khush K, Kao A, et al. Surveillance with Dual Non-Invasive Testing for Acute Allograft Injury After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. 2024; 43(5): 646–657.
2. Khush K, Hall S, Kao A, et al. Surveillance with Dual Non-invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. Volume 43, Issue 9, 1409 – 1421.
3. Kim PJ, Alam AH, Teuteberg JJ, Khush KK, et al. Donor-Derived Cell-Free DNA in Antibody-Mediated Rejection: An Analysis of the Surveillance HeartCare Outcomes Registry (SHORE).Journal of the American College of Cardiology: Heart Failure. 2026; 14(1): 102716.

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CareDx, Inc.
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Natasha Moshirian Wagner
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Caroline Corner
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Source: CareDx, Inc.