SOUTH SAN FRANCISCO, Calif., Nov. 24, 2025 — CareDx, Inc., a leader in precision medicine for transplant patients, announced the publication of the third major analysis from the Surveillance HeartCare Outcomes Registry (SHORE) in the Journal of Heart and Lung Transplantation. The study, titled “Multimodal Molecular Testing Provides Prognostic Value for Heart Transplant Recipients,” demonstrates that HeartCare®, which includes AlloMap® gene-expression profiling and AlloSure® Heart donor-derived cell-free DNA testing, provides critical prognostic insights into graft dysfunction and cardiovascular death risk—information often missed by biopsy alone.
Science Significance
The scientific impact of this third SHORE publication is profound: with data from 1,934 heart transplant recipients across 59 centers, the study provides one of the most comprehensive real-world evaluations of molecular surveillance in transplant care. The findings show that positive HeartCare signals can detect elevated risk even when histology appears normal, revealing subclinical rejection pathways undetected by traditional biopsy. Notably, patients with combined AlloMap and AlloSure elevations faced a nearly twofold increase in graft dysfunction and cardiovascular death, highlighting how multimodal molecular diagnostics outperform single-modality surveillance. This evidence shifts the scientific understanding of transplant rejection toward precision, biology-driven metrics that improve early detection and guide interventions.
Regulatory Significance
While HeartCare is already integrated into clinical practice under CLIA and CAP laboratory frameworks, the SHORE findings strengthen its standing in regulated transplant monitoring by demonstrating independent prognostic value—a key element regulators evaluate when considering clinical utility. The results support future discussions around standard-of-care evolution, potentially informing guideline updates for post-transplant risk assessment. As regulatory agencies increasingly emphasize evidence-based diagnostics and patient-risk stratification, HeartCare’s validated ability to identify high-risk patients—even in the absence of histological rejection—aligns with modern expectations for advanced, compliant, and clinically validated diagnostic tools.
Business Significance
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For CareDx, these findings reinforce HeartCare’s position as a differentiated, high-value diagnostic suite in the competitive transplant-surveillance market. Demonstrating superiority over biopsy alone expands its appeal to transplant centers seeking non-invasive, data-rich, and cost-effective monitoring solutions. The SHORE results strengthen the commercial argument for broader adoption, support CareDx’s outreach to payers regarding reimbursement, and highlight its leadership in precision transplant medicine. With HeartCare offering prognostic insights across 2 months to 5 years post-transplant, the platform’s long-term utility enhances CareDx’s revenue stability and strategic value in the global transplant-diagnostic landscape.
Patients’ Significance
For heart transplant patients, these findings offer a major step toward personalized, safer, and more proactive post-transplant care. Traditional biopsies, while informative, may miss emerging graft injury—yet the SHORE study shows that HeartCare detects risk earlier and more accurately, enabling clinicians to adjust therapy, schedule closer monitoring, or intervene before complications worsen. The ability to identify patients at the highest risk for graft dysfunction or cardiovascular death can significantly improve survival, reduce hospitalizations, and offer peace of mind. Ultimately, HeartCare empowers clinicians to practice truly individualized transplant medicine, improving outcomes for thousands of patients worldwide.
Policy Significance
The SHORE findings align with emerging healthcare policy priorities around reducing invasive procedures, increasing diagnostic precision, and improving long-term outcomes for high-risk patients. As transplant care remains one of the most resource-intensive specialties, tools like HeartCare support policy goals emphasizing value-based care, preventive monitoring, and reduction of avoidable adverse events. The strong multi-center data set also supports potential inclusion in national transplant-monitoring guidelines, broader payer coverage, and future policy conversations about incorporating multimodal molecular diagnostics into routine standards of care.
The latest SHORE publication solidifies HeartCare’s role as an essential prognostic tool in modern heart-transplant surveillance, demonstrating powerful predictive capabilities that surpass conventional biopsy alone. With robust scientific validation, clear clinical utility, and strong alignment with evolving regulatory and policy expectations, HeartCare represents the future of precision transplant management. As CareDx continues pioneering innovation in transplant medicine, these findings underscore the technology’s potential to transform patient care through earlier detection, more personalized monitoring, and significantly improved long-term outcomes.
Source: CareDx, Inc. press release
