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FDA Approves First Test for Cancer Gene Profiling

The testing is expected to help more patients and guide treatment

FDA approves testing for genetic mutations

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Tumor-gene profiling will become more available to more cancer patients and insurers are expected to cover the treatment.

U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what's driving a patient's tumor and aiding efforts to match treatments to those flaws.

The U.S. Food and Drug Administration (FDA) 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, recently announced, will 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's essentially individualized, precision medicine," said Kate Goodrich, chief medical officer for the Medicare oversight agency.

Currently, patients may get tested for individual genes if a drug is available to target those mutations. It's a hit-and-miss approach that sometimes means multiple biopsies and wasted time.

The new FoundationOne CDx test can be used for any solid tumor — such as prostate, breast or colon cancer — and surveys 324 genes plus other features that can help predict success with treatments that enlist the immune system.

"Instead of one or two, you have many" tests at once from a single tissue sample, said the FDA's Jeffrey Shuren. The tests give better and more information to guide treatment and can help more patients find and enroll in studies of novel therapies, he said.

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