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Breakthrough-designated companion diagnostic approved for over 300 genes, 5 tumor types

The next-generation sequencing (NGS)-based test achieved parallel approval by the FDA and coverage by the CMS.
FDANovember 30, 2017—Today, the U.S. Food and Drug Administration (FDA), in coordination with the Centers for Medicare & Medicaid Services (CMS), announced the approval and coverage of the FoundationOne CDx (F1CDx) cancer biomarker assay, an NGS-based in vitro diagnostic (IVD) test. This is the second IVD to be approved and covered by the overlapping FDA/CMS Parallel Review Program.
F1CDx detects 324 different genes and can identify actionable mutations across 5 solid tumor types, providing readouts for 15 different targeted therapies. Additionally, the assay can detect microsatellite instability and tumor mutational burden, which are both associated with response to immunotherapy. In the approval announcement, the FDA stated F1CDx was able to accurately detect substitutions, and indel mutations approximately 94.6% of the time for each of the 324 genes.
The companion diagnostic can be used as to identify mutations in non-small cell lung cancer (NSCLC), melanoma, as well as breast, colorectal, and ovarian cancers. The F1CDx is capable of detecting genetic mutations that indicate multiple treatments, extending beyond the “one test for one drug” model. The assay can detect alterations in EGFR, KRAS, BRAF, BRCA1/2, ALK, and several other genes.
“The F1CDx can help cancer patients and their healthcare professionals make more informed care decisions without the often-invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in the approval press release. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”
CMS simultaneously proposed a national coverage determination of F1CDx and other NGS-based IVDs for Medicare beneficiaries with recurrent, metastatic, or other advanced cancers. The coverage determination is limited to patients who have not been previously tested using the same companion diagnostic, but that continue to seek cancer treatment.
“Through parallel review and collaboration, we speed access to innovative diagnostics, so that doctors are better able to deliver the best quality care to their patients and patients have access to these state-of-the-art tests,” said Seema Verma, Administrator of CMS in the same press release. “Our proposal establishes clear expectations, while at the same time delivering better outcomes for the people we serve.”
Generally, the FDA does not enforce premarket review for laboratory-developed tests.
However, at the request of F1CDx developers, the FDA approved the assay through the newly established Breakthrough Device Program due to the test’s potential to consolidate multiple companion diagnostics into a single test.
“By leveraging two policy efforts aimed at expediting access to promising new technologies, we’ve been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs,” said FDA Commissioner Scott Gottlieb, MD. “The FDA’s Breakthrough Device Program and Parallel Review with CMS allowed the sponsor to win approval for this novel diagnostic and secure an immediate proposed Medicare coverage determination within six months of the FDA receiving the product application.”
Jonathan A. Bell
Published Online: Thursday, November 30, 2017 

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