FDA Approves NGS-Based IVD Test With Breakthrough Designation

The FDA has approved the first next generation sequencing (NGS)-based in vitro diagnostic test with breakthrough designation, FoundationOne CDx (F1CDx).

The IVD test is the second to be approved under the FDA/CMS Parallel Review Program, in which the FDA collaborates with the Centers for Medicare and Medicaid Services to expedite the review process for Medicare beneficiaries to have earlier access to innovative medical technologies.

The test differs from other companion diagnostics the FDA has previously reviewed in that it “extends beyond the ‘one test for one drug’ model,” the agency said. The F1CDx can detect mutations in 324 genes and two genomic signatures by sequencing DNA in solid tumor samples.

The Breakthrough Device Program and Parallel Review Program allowed the sponsor to win approval for the novel diagnostic and secure an immediate proposed Medicare coverage determination within six months of the FDA receiving the product application, said FDA Commissioner Scott Gottlieb.