FDA Approves First-of-a-Kind Test for Cancer Gene Profiling

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Cancer Gene
Food and Drug Administration campus, in Silver Spring, Md.  (AP Photo/Andrew Harnik, File)

U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once using a single tumor sample. This gives a more complete picture of what’s driving a patient’s tumor and aids efforts to match treatments to those flaws.

The Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

The dual decisions announced late Thursday will quickly make tumor gene profiling available to far more cancer patients than the few who get it now, and lead more insurers to cover it.

It also will help more patients find and enroll in studies testing new drugs that target specific genes.

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