CareDx Announces Largest Landmark Study of Its Kind on Antibody Mediated Rejection in Heart Transplantation Published in Journal of the American College of Cardiology

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On Oct. 23, 2025, CareDx announced the publication of the second study from Surveillance HeartCare Outcomes Registry (SHORE) in the Journal of the American College of Cardiology: Heart Failure.

It is the largest prospective analysis of antibody-mediated rejection (AMR) in heart transplantation, including 2,240 patients across 59 U.S. transplant centers and analyzing 24,768 biopsies, 8,851 paired donor-derived cell-free DNA (dd-cfDNA) samples measured using AlloSure® Heart, and 136 AMR-positive biopsies paired with dd-cfDNA results. AlloSure, in combination with AlloMap, form HeartCare – a non-invasive and clinically validated approach to heart transplant surveillance.

The second SHORE study established a new benchmark in transplant diagnostics as the largest published dataset for molecular testing in AMR and demonstrated that AlloSure Heart results ≥0.50% were highly specific (92.8%) for AMR diagnosis.

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Source: CareDx
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