CareDx's SHORE Study Validates AlloSure Heart as Reliable Biomarker for Heart Transplant Rejection
核心洞察
CareDx published the largest prospective analysis of antibody-mediated rejection (搜索) in heart transplantation, analyzing 2,240 patients across 59 U.S. transplant centers with 24,768 biopsies and 8,851 paired donor-derived cell-free DNA (搜索) samples.
The SHORE study demonstrated that AlloSure Heart (搜索) results ≥0.50% were highly specific (92.8%) for antibody-mediated rejection (搜索) diagnosis, establishing new benchmarks in transplant diagnostics.
The study validated context-dependent thresholds that may safely reduce unnecessary biopsies for patients with low pre-test probability while supporting treatment response monitoring capabilities.
CareDx announced the publication of the second study from its Surveillance HeartCare (搜索) Outcomes Registry (SHORE) in the Journal of the American College of Cardiology: Heart Failure, representing the largest prospective analysis of antibody-mediated rejection (搜索) (AMR) in heart transplantation to date. The landmark study analyzed 2,240 patients across 59 U.S. transplant centers, examining 24,768 biopsies, 8,851 paired donor-derived cell-free DNA (搜索) (dd-cfDNA) samples measured using AlloSure Heart (搜索), and 136 AMR-positive biopsies paired with dd-cfDNA results.
Validation of Non-Invasive Biomarker
The study established AlloSure Heart (搜索) as a reliable biomarker for antibody-mediated rejection (搜索), with results ≥0.50% demonstrating high specificity (92.8%) for AMR diagnosis. AlloSure Heart, combined with AlloMap (搜索), forms HeartCare (搜索)—a non-invasive and clinically validated approach to heart transplant surveillance.
"SHORE is a landmark in heart transplantation, validating AlloSure Heart (搜索) 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."
Key Clinical Findings
The SHORE study revealed several critical insights for heart transplant management. Elevated AlloSure Heart (搜索) levels were strongly associated with biopsy-proven AMR, with higher values correlating with more severe grades of rejection. The research established context-dependent thresholds based on clinical scenarios, demonstrating that for patients with low pre-test probability—those without donor-specific antibodies (DSA) and normal graft function—higher thresholds (≥0.50%) may safely reduce unnecessary biopsies.
For patients with modest elevations (0.2-0.49%), the study indicated that biopsies should only be triggered if AlloMap (搜索) is positive, indicating a risk of acute cellular rejection (搜索) (ACR). Additionally, AlloSure Heart (搜索) levels declined following presumed treatment for AMR, supporting its utility as a marker for therapeutic response monitoring.
Advancing Transplant Diagnostics
The second SHORE study established a new benchmark in transplant diagnostics as the largest published dataset for molecular testing in AMR. Robert Woodward, Chief Scientific Officer of CareDx, emphasized the significance of these findings: "SHORE provides compelling evidence that HeartCare (搜索), which includes AlloMap (搜索) and also AlloSure Heart (搜索), can optimize biopsy utilization and clinical decision-making in heart transplant care. With the largest AMR molecular dataset to date, CareDx continues to set the standard for data-driven non-invasive testing."
The comprehensive analysis represents a significant advancement in precision medicine for transplant patients, potentially reducing the need for invasive surveillance biopsies while maintaining diagnostic accuracy. The study's large scale and multi-center design provide robust evidence for the clinical utility of donor-derived cell-free DNA (搜索) testing in heart transplant monitoring.