FDA, CMS Pursue Concurrent Reviews for 'Innovative' Diagnostics

January 22, 2018
FDA, CMS Pursue Concurrent Reviews for 'Innovative' Diagnostics
[Source: zimmytws / Adobe Stock]

Alex Philippidis

Foundation Medicine’s FoundationOne CDx assay for solid tumor cancers is a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) device intended to identify patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 approved as first-line therapies.
Since November 30, the cancer test has enjoyed yet another distinction. FoundationOne CDx is the second IVD to win FDA approval and a concurrent coverage proposal from the Centers for Medicare & Medicaid Services (CMS) through their Parallel Review Program. 
The FDA authorization for FoundationOne CDx is the agency’s first for a comprehensive genomic profiling test for all solid tumors incorporating multiple companion diagnostics. FoundationOne CDx is designed to detect substitutions, insertion and deletion alterations (indels), and copy number alterations in 324 genes and select gene rearrangements. It is also designed to detect genomic signatures, including microsatellite instability and tumor mutational burden, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
Foundation Medicine also received a proposed National Coverage Determination (NCD) from CMS for FoundationOne CDx and other similar NGS IVDs for Medicare beneficiaries with advanced cancer—including recurrent, metastatic, or advanced Stage IV cancer—who have not been previously tested using the same NGS technology and continue to seek further cancer therapy.

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