The FDA approved Foundation Medicine's cancer gene test Thursday. CMS also proposed national coverage of the test for Medicare beneficiaries with advanced cancer.
The FoundationOne CDx is an in vitro diagnostic test that uses next-generation sequencing to identify genetic mutations in 324 genes and two genomic signatures for all solid tumor types. Unlike other companion diagnostic tests, which only assess a patient's potential benefits for one drug, Foundation Medicine's test can detect numerous genetic mutations at once to identify which patients with any of five tumor types could benefit from 15 different targeted cancer drugs.
"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. "With the run of one test, patients and healthcare professionals can now evaluate several appropriate disease management options."
FoundationOne CDx is the second genetic test to earn regulatory approval and proposed coverage after concurrent review by the FDA and CMS through the Parallel Review Program. The program seeks to give Medicare patients earlier access to new medical technologies by shortening the time between when a treatment receives regulatory approval and earns Medicare coverage status.
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