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Foundation Medicine’s Cancer Gene Test Gains FDA and CMS Approval

The Centers for Medicare and Medicaid Services propose covering the test with Medicare. 

Dec 1, 2017
Diana Kwon

FLICKR, FDAOn Thursday (November 30), the US Food and Drug Administration (FDA) approved Foundation Medicine’s in vitro diagnostic test for solid tumor cancers. This diagnostic tool is designed to help physicians identify which patients would benefit from more than a dozen FDA-approved targeted treatment options and determine candidacy for clinical trials. The Centers for Medicare and Medicaid Services (CMS) concurrently submitted a preliminary National Coverage Determination for the device, proposing coverage for Medicare patients.

The Cambridge-based company’s test, FoundationOne CDx (F1CDx), can detect cancer-causing mutations in 324 genes for any solid tumor, including those in the breast, lungs, and ovaries. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, says in a statement.

F1CDx is the second in vitro diagnostic test to receive coordinated approval by the two agencies through the FDA-CMS Parallel Review Program, which aims to give Medicare beneficiaries earlier access to new medical technologies. The first was a noninvasive colorectal cancer test developed by Exact Sciences, which was greenlighted by the FDA in 2014.

This program “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,” FDA Commissioner Scott Gottlieb says in a statement.

See “Opinion: More Biomarkers Needed for Cancer Immunotherapy” 

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