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FDA Approves NGS Test for Multiple Mutations

FDA Approves NGS Test for Multiple Mutations

January 10, 2018

by Arturo Loaiza-Bonilla, MD, MSEd

The FDA approved a next-generation sequencing test that can detect multiple mutations in any solid tumor.

At the same time, the Centers for Medicare and Medicaid Services (CMS) proposed Medicare coverage of Foundation Medicine's FoundationOneCDx (F1CDx).

The F1CDx is the first NGS-based in vitro diagnostic (IVD) test and can simultaneously can detect mutations in 324 genes and two genomic signatures in any type of solid tumor. Other companion diagnostics match one test to one drug. By providing information on many genetic mutations, the F1CDx can help identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted therapies.

This FDA approval and CMS proposal for reimbursement is great news for the field of precision medicine and clinical trials, and a benefit for many of our cancer patients. The FoundationOne CDx (F1CDx) test will cover all of currently approved companion diagnostics under a single platform, and will allow for easier acquisition and reimbursement of biomarker-driven oncolytics, as well as providing rationale for clinical trial enrollment in precision oncology studies.

Loiaza-Bonilla is affiliated with Cancer Treatment Centers of America. 

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