Gene Tests to Match Patients To Therapy Get FDA Oversight

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Commonly used tests to predict disease or match a cancer patient with the drug most likely to work will be more strictly regulated under a U.S. Food and Drug Administration proposal. The plan released yesterday means the agency will review in advance all tests for genetic mutations that help doctors and their patients choose the best treatment options. For example, actress Angelina Jolie said she used Myriad Genetics Inc. (MYGN)’s screens for a gene defect in breast cancer to help her decide to undergo a double mastectomy after learning she carried a mutation associated with a high risk of the disease.

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