Benzinga | Jan 6, 2022 07:15AM EST

CareDx Successfully Completes CLIA Validation Of AlloMap Kidney In Preparation For Commercial Launch

CareDx, Inc. (NASDAQ:CDNA) -- The Transplant Company(tm) focused on the discovery, development, and commercialization of clinically differentiated, healthcare solutions for transplant patients and caregivers -- today announced the successful completion of the Clinical Laboratory Improvement Amendments (CLIA) validation for AlloMap(r) 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 0.894.1Together, 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.

"As the market leader in transplant and the company that consistently delivers innovations to improve outcomes for transplant recipients, we are excited that our first and best-in-class technologies, and expertise in multimodality HeartCare, are being used in KidneyCare," said Reg Seeto, CEO and President of CareDx. "We are pleased to have completed 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."

"Multimodality assessment of allograft health represents the next important step in the evolution of kidney transplant care. By adding an immune quiescence assessment to organ rejection monitoring, clinicians can tailor earlier therapeutic interventions that not only improve health outcomes, but ultimately improve overall quality of life by reducing the need for dialysis use," said Enver Akalin, MD, at Montefiore Medical Center. "This CLIA validation brings us one step closer to being able to use AlloMap Kidney in our practice and I look forward to being able to incorporate it along with AlloSure Kidney for a more complete assessment of my patient's organ transplant health."