CareDx Announces Publication Of The Second Study From Surveillance Heartcare Outcomes Registry In The Journal Of The American College Of Cardiology; Second Shore Study Validates AlloSure Heart, An Integral Component Of Heartcare, As A Reliable Biomarker For Antibody-Mediated Rejection In Heart Transplant Recipients

Author: Benzinga Newsdesk | October 23, 2025 04:18pm

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 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.

"SHORE is a landmark in heart transplantation, validating AlloSure Heart as a reliable biomarker for antibody mediated rejection and enabling more precise, context-driven decision-making," said Amit Alam, MD, Assistant Professor, Department of Medicine at NYU Grossman Long Island School of Medicine and author of the publication. "This study empowers clinicians to further reduce surveillance biopsies and improve patient care."

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.

Key Findings

• AlloSure Accurately Identified AMR: Elevated AlloSure Heart levels were strongly associated with biopsy-proven AMR, with higher values correlating with more severe grades of rejection.
• HeartCare Enabled Context-Dependent Thresholds: Different AlloSure thresholds were established based on clinical context. For patients with low pre-test probability (no DSA, normal graft function), higher thresholds (≥0.50%) may safely reduce unnecessary biopsies and modest elevations (0.2-0.49%) should only trigger biopsies if AlloMap is positive indicating a risk of ACR.
• Treatment Response Monitoring: AlloSure Heart levels declined following presumed treatment for AMR, supporting its use as a marker for therapeutic response.

"SHORE provides compelling evidence that HeartCare, which includes AlloMap and also AlloSure Heart, can optimize biopsy utilization and clinical decision-making in heart transplant care," said Robert Woodward, Chief Scientific Officer of CareDx. "With the largest AMR molecular dataset to date, CareDx continues to set the standard for data-driven non-invasive testing."

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