CareDx在《美国移植杂志》上发表KOAR研究，展示AlloSure dd-CFDNA用于增强肾排斥检测和活检指导

KOAR, the Largest Prospective Study of Its Kind, Demonstrates Clinical Utility of AlloSure® in Kidney Transplant Surveillance

AlloSure Kidney dd-cfDNA Elevation Strongly Predicts Rejection and Improves Biopsy Yield

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 the publication of the Kidney Allograft Outcomes AlloSure Registry (KOAR) study in the American Journal of Transplantation. The landmark prospective study demonstrates the clinical utility of AlloSure® donor-derived cell-free DNA (dd-cfDNA) in improving rejection detection and guiding biopsy decisions in kidney transplant recipients.

The KOAR study enrolled 1,743 patients across 56 U.S. transplant centers to evaluate the clinical utility of a dd-cfDNA surveillance protocol based on the DART study, which prescribed seven tests in year one and four annually in years two and three. A total of 18,584 AlloSure tests were obtained from the overall cohort.

Key findings include:

• Elevated AlloSure was associated with a 6-fold increase in rejection yield in surveillance biopsies (39% vs. 7%, p<0.001) and a 4-fold increase in for-cause biopsies (47% vs. 12%, p<0.001).
• AlloSure elevations were detectable up to four months before ABMR and one month before TCMR, supporting its role in early detection and longitudinal monitoring.
• In post-biopsy monitoring, AlloSure levels declined significantly following treatment, while serum creatinine remained unchanged, reinforcing AlloSure's role in assessing treatment response.

The study also demonstrated that dd-cfDNA levels correlate with rejection severity, with higher levels associated with ABMR and mixed rejection, and lower levels linked to borderline or TCMR 1A. This stratification capability positions AlloSure as a critical tool for tailoring immunosuppression and biopsy decisions based on individual patient risk.