FDA and the Centers for Medicare and Medicaid Services have accepted the FoundationOne comprehensive genomic profiling assay for parallel review. FDA also accepted Foundation Medicine’s request for review as part of its Expedited Access Pathway for breakthrough devices.
If approved, the assay would be the first to incorporate multiple companion diagnostics to support precision medicine in oncology, including an indication for use as a companion diagnostic across a diverse range of solid tumors, according to Foundation Medicine.
Obtaining a Medicare National Coverage Determination from CMS concurrently will allow FoundationOne to be offered as a covered benefit under Medicare. Foundation Medicine expects the review will conclude in the second half of 2017.
“While we proceed with FDA and CMS, we will continue our work with Palmetto GBA, our Medicare Administrative Contractor in North Carolina and a recognized thought leader in molecular diagnostics,” said Michael Pellini, chief executive officer of Foundation Medicine. “We will also continue our work with the MAC in Massachusetts, National Government Services. Specifically, we will work with Palmetto through its MolDx Program to expand coverage of well-validated CGP assays, such as FoundationOne, to include additional cancer indications beyond the existing local coverage determination, which currently covers a subset of patients with non-small cell lung cancer.”
