Benzinga | Apr 22, 2021 11:39AM EDT

CareDx Announces Palmetto MolDx Finalized Local Coverage Determination 'Molecular Testing For Solid Organ Allograft Rejection'

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, announced today that Palmetto MolDx finalized the local coverage determination "Molecular Testing for Solid Organ Allograft Rejection," reaffirming coverage and patient access to transplant testing services.



Medicare coverage for CareDx services remains unchanged under the new foundational coverage policy. This policy provides greater access to care and establishes a faster path to coverage of other solid organs in transplantation.

"We applaud Palmetto MolDx in this policy to support the field of transplant," said Reg Seeto, President and CEO of CareDx. "This aligns with our mission for patient care and we are so 'transplant proud' to have been the first to have brought both gene expression profiling with AlloMap(r) and dd-cfDNA with AlloSure(r) to the transplant field."

AlloMap Heart is the only FDA cleared gene expression profiling test in transplant and is widely adopted by physician providers in over 90% of heart transplant centers across the U.S. The test has been the standard of care and included in guidelines for the International Society for Heart and Lung Transplantation (ISHLT) since 2010. HeartCare is a validated multimodality use of AlloMap Heart with AlloSure Heart.

AlloSure Kidney and AlloSure Heart are dd-cfDNA precision medicine molecular tests which identify underlying cell injury as an indicator of organ rejection. AlloSure Kidney and AlloSure Heart coverage followed rigorous technical assessments and underscores the value of dd-cfDNA testing for transplant patient management. Both tests were validated in multicenter prospective studies published in peer reviewed journals and have a growing suite of published evidence surrounding the clinical utility of AlloSure in managing patient care.