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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
BRISBANE, Calif.--(BUSINESS WIRE)-- 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.
“The scale and clarity of KOAR make it a landmark,” said Daniel C. Brennan, MD, Professor of Medicine at Johns Hopkins, author of the publication, and the senior author of the primary DART publication. “In fact, it shows that dd-cfDNA should be considered the first-line test even before DSA. It’s arguably the most powerful biomarker we have in kidney transplantation today.”
“KOAR confirms that dd-cfDNA is a clinically actionable tool that enhances how we detect and manage rejection,” said Jonathan S. Bromberg, MD, PhD, Professor of Surgery at the University of Maryland, lead author of the publication, and a key author on the DART publications. “Importantly, it helps clinicians tailor care based on risk.”
Key findings include:
