CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the enrollment of the first patient in the Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE) Study at Mount Sinai Hospital in New York.
MAPLE is a multi-center, prospective study of the LiverCare platform, a novel multi-modality approach to assess the status of liver allografts. LiverCare will include the following:
AlloSure® Liver — donor-derived cell-free DNA-based measure of organ injury
AlloMap® Liver — gene expression profiling assessment of recipient immune system activity
AlloHeme™ Liver — blood-based micro-chimerism surveillance solution
HistoMap Liver — tissue-based gene expression profiling assessment of allograft rejection and injury
AlloID™ — blood-based metagenomic infectious disease identification
In addition, LiverCare includes a proprietary machine learning algorithm to predict allograft outcomes based on clinical parameters.
The study, which was first announced earlier this year, will enroll 1500 liver transplant recipients and marks the beginning of CareDx’s work in liver transplant. The first enrolled patient demonstrates the continued momentum behind the study and CareDx’s commitment to patient care across transplant organ types.
“MAPLE will help us define the application of multi-modality testing in liver transplant,” said Dr. Sham Dholakia, Senior Vice President of Medical Affairs at CareDx. “As leaders in transplantation, CareDx was first to market with surveillance tests supported by clinical data in kidney and heart, and we are leading in lung. We will continue to invest in clinical data development and follow the science in support of transplant patients.”
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