CareDx completes validation of AlloMap Kidney clinical laboratory improvement amendments

January 12, 2022

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CareDx Inc. announced in a press release that its AlloMap Kidney has completed validation of clinical lab improvement changes, allowing it to move forward for a commercial launch.

AlloMap Kidney is designed to be a blood-based gene expression classifier that determines immune quiescence in kidney transplant patients. Researchers tested AlloMap in a clinical trial published in Kidney360 and has shown its ability to differentiate between rejection and rejection of antibody drugs and immune quiescence.

“We are happy to have finished [Clinical Laboratory Improvement Amendments] On-schedule CLIA validation of AlloMap Kidney and one step closer to commercialization of KidneyCare, a revolutionary multimodal solution that will help clinicians more comprehensively monitor the organ health of their kidney transplant patients ”, Reg Seeto, CEO and chairman of CareDx, said in the statement.

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