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FDA Approves Screening Test for Cancer Gene

The FDA has approved the FoundationOne CDx, a first-of-a-kind test that seeks mutations in hundreds of cancer genes help narrow causes for tumors.

Tumor Profiling / Image: AP Photo/Gregory Bull
Tumor Profiling / Image: AP Photo/Gregory Bull

Today, cancer patients get tested for individual genes if a treatment that targets those mutations is available. This is a hit-and-miss approach that requires multiple biopsies and a great deal of time. However, a recent Medical Xpress article reported on a new cancer gene-profiling test capable of screening hundreds of cancer genes at once to better indicate the cause of a tumor and what treatments might work.

The FoundationOne CDx test is relevant to any solid tumor and monitors 324 genes to predict treatment success and trigger the immune system. With the FDA’s approval and the government’s proposed coverage for Medicare, private insurers will likely join in.

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Break out of the ordinary: see what’s new in life sciences packaging