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FDA approves DTC test for breast cancer risk, with caveats

The FDA approved 23andMe's direct-to-consumer test for three BRCA gene mutations linked to breast cancer, but the agency warned that most other BRCA mutations associated with an elevated breast cancer risk are not covered by the test. "The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk," the FDA's Donald St. Pierre said.

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