FDA, CMS: Second Parallel Review Decision Ever for NGS Test
By Michael Mezher -
Published 01 December 2017
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.
Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration
Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device