CareDx Inc. announced the successful completion of the Clinical Laboratory Improvement Amendments (CLIA) validation for AlloMap® Kidney, a blood-based gene expression classifier that identifies immune quiescence, an important biomarker needed to comprehensively assess immunological risk of rejection and allograft health. In clinical validation, published in Kidney360, AlloMap Kidney demonstrated the ability to differentiate between rejection (both T-cell mediated rejection [TCMR] and antibody-mediated rejection [AMR]) and immune quiescence, and provide an assessment of immunological activity additive to the allograft injury information derived from AlloSure Kidney donor-derived cell-free DNA (dd-cfDNA), with a combined area under the curve (AUC) of 0.894.1 Together, these two biomarkers offer a more comprehensive assessment of kidney health compared to the current standard of care. CareDx's AlloMap Kidney along with AlloSure Kidney forms KidneyCare, a multimodality solution that has been studied in the Outcomes of KidneyCare in Renal Allografts (OKRA) registry across 50 transplant centers.