New data demonstrates clinical utility of AlloSure in repeat kidney transplant recipients

Dec 21 2018

CareDx, Inc., a leading molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announces the publication of data demonstrating the clinical utility of measuring AlloSure in repeat kidney transplant recipients in the American Journal of Transplantation.

AlloSure is the first donor-derived cell-free DNA test to assess allograft health and is broadly available to transplant patients. Previous publications demonstrating the clinical value of AlloSure were based on first-time or single kidney transplant recipients (SKTR); the current study is the first study to include repeat kidney transplant recipients (RKTR).

A significant percentage of patients require repeat kidney transplants and are at a higher risk for rejection. There is an unmet need for a non-invasive diagnostic test to help clinicians closely monitor and optimize care for these patients. We are glad to see AlloSure demonstrate significant clinical utility in this population.”

Roslyn Mannon, M.D., Professor of Medicine and Surgery at the University of Alabama at Birmingham

Key highlights from the study:

• In patients without evidence of rejection, the median readouts of AlloSure were significantly lower than threshold levels for rejection in both SKTR and RKTR
• In patients with active rejection, AlloSure levels were similarly elevated in SKTR and RKTR patients alike

CareDx believes in personalizing healthcare for all kidney transplant patients including those at high risk. This peer-reviewed publication supports the expanded clinical utility of AlloSure to include repeat kidney transplant recipients.”

James Yee, M.D., Ph.D., Executive Vice President and Chief Medical Officer at CareDx, Inc.