CareDx completes Clinical Laboratory Improvement Amendments validation of AlloMap Kidney
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CareDx Inc. announced in a press release that its AlloMap Kidney completed the Clinical Laboratory Improvement Amendments validation, 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 showed its ability to differentiate between rejection and antibody-medicated rejection and immune quiescence.
“We are pleased to have completed [Clinical Laboratory Improvement Amendments] CLIA validation of AlloMap Kidney on schedule and to be moving a step closer to the commercialization of KidneyCare, a breakthrough multimodality solution that will help clinicians more comprehensively monitor the organ health of their kidney transplant patients,” Reg Seeto, CEO and president of CareDx, said in the release.
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