FDA has approved the FoundationOne CDx (F1CDx) cancer biomarker assay concurrently with a decision from the Centers for Medicare & Medicaid Services (CMS) to provide insurance coverage for the next-generation sequencing (NGS)-based in vitro diagnostic (IVD) test.
FDA Approves Foundation Medicine’s FoundationOne CDx™, the First and Only Comprehensive Genomic Profiling Test for All Solid Tumors Incorporating Multiple Companion Diagnostics.
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