Breadth of Data Demonstrates Growing Real-World Adoption and Clinical Importance of CareDx Testing Solutions in Heart and Lung Transplant Patient Management

New SHORE Study Findings Demonstrate that HeartCare is Prognostic of Long-Term Outcomes and Informs Treatment Decisions

BRISBANE, Calif., April 24, 2025--(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 that CareDx, together with study collaborators from leading transplant centers, will present the latest advancements in clinical evidence supporting its transplant care solutions at the International Society for Heart and Lung Transplantation (ISHLT) 45^th Annual Meeting & Scientific Sessions, held from April 27-30 in Boston, Massachusetts.

The real-world clinical use and scientific advancements involving HeartCare™, AlloSure^® Heart, AlloMap^® Heart, AlloSure Lung, and AlloHome™ will be featured in 60 abstracts, 19 oral presentations, and two symposia that include data generated from studies at 92 transplant centers.

"Adoption of our heart and lung transplant solutions in real-world practice continues to grow because of the expanding body of scientific evidence of the clinical importance of our testing services to transplant patient management. The latest evidence from our multi-center SHORE study suggests HeartCare is prognostic of long-term graft outcomes independent of biopsy results, and that HeartCare is utilized in a real-world setting to manage immunosuppression dosing," said John W. Hanna, CareDx President and CEO. "We look forward to this year’s ISHLT which will include two CareDx Sponsored Symposia on the latest evidence in molecular management of heart and lung transplant patients presented by leading clinicians in the field from NY Presbyterian/Columbia, Penn Medicine, UC San Diego, Tampa General, NYU Langone, Vanderbilt University, UCLA, and the Miami Transplant Institute."

Key Study Findings in Heart Transplant

• Dual-positive HeartCare (AlloSure and AlloMap Heart) results are prognostic of worse outcomes even when the biopsy is normal (Abstract 240).
• Early surveillance with HeartCare led to similar 5-year survival and rejection-free survival compared to using AlloMap and biopsy, and required significantly fewer biopsies (Abstract 1351).
• Biopsies performed concurrently or after dual-negative HeartCare results, were not associated with improved outcomes (Abstract 238).
• Real-world data shows that clinicians use HeartCare results not only to decide which patients require a biopsy, but which patients can have their prednisone dose lowered (Abstract 187).
• HeartCare was shown to effectively monitor rejection in clinically relevant populations including women (Abstract 61), Black Americans (Abstract 64) and patients with chronic kidney disease (Abstract 1337).

Key Study Findings in Lung Transplant

• Surveillance monitoring using AlloSure Lung effectively identified rising dd-cfDNA levels signaling onset of acute cellular rejection and decline in levels after treatment for rejection (Abstract 1627).
• AlloHome remote patient monitoring system in lung transplant patients enables real-time treatment adjustments and improved triage, easing workload on transplant center staff (Abstract 1204).

CareDx Sponsored Symposia

A distinguished group of experts will present the utility of using HeartCare and AlloSure Lung in clinical decision-making and in the management of real-world scenarios during two symposia sponsored by CareDx:

• HeartCare in 2025: Is Molecular Multimodality the Secret to Liquid Biopsy? Moderated by Jeremy Kobulnik, MD, Sr. Medical Director, CareDx. Panelists include: Ersilia M. DeFilippis, MD, FACC, FHSA, NY Presbyterian/Columbia University Irving Medical Center; H. Luise Holzhauser, MD, Penn Medicine; Marcus Anthony Urey, MD, UC San Diego Health; Benjamin Mackie, MD, Tampa General Hospital.

• From Bench to Bedside: Is Lung Transplant Ready for the dd-cfDNA Revolution? Moderated by Jake G. Natalini, MD, NYU Langone. Panelists include: Ciara Shaver, MD, PhD, Vanderbilt University, S. Samuel Weigt, MD, UCLA; Juan Fernandez Castillo, MD, Miami Transplant Institute-Jackson Memorial Hospital.

For a complete listing of abstracts, oral presentations and posters please follow this link.

About 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 dd-cfDNA and AlloMap Heart GEP or HeartCare. Together, 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. A recent landmark study published in the Journal of Heart and Lung Transplantation¹ showed that HeartCare outperforms dd-cfDNA alone in identifying rejection and patients experienced excellent outcomes with fewer biopsies.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and 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, Inc., including statements regarding the potential benefits and results that have been or may be achieved with AlloSure Heart, AlloMap Heart, HeartCare, AlloSure Lung, AlloHome and other CareDx products, and statements regarding the interim study results of CareDx’s SHORE registry and ALAMO study presented at the 2025 ISHLT meeting (the "ISHLT Presentation"). 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 Heart, AlloMap Heart, HeartCare, AlloSure Lung, AlloHome, or other CareDx products; risks that the ISHLT Presentation and the data to be presented may not follow the agenda as stated in this press release; risks that the findings in the 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, 2024 filed by CareDx with the SEC on February 28, 2025, 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. 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.

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Contacts

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