FDA Gives 23andMe Approval To Check For BRCA Mutations

BOSTON (CBS) – For the first time the FDA has granted permission to market a direct-to-consumer genetic test to check for BRCA mutations that are associated with breast and ovarian cancer.

23andMe, a company which uses a saliva sample to analyze DNA, provides information to consumers about ancestry as well as certain genetic health risks. Now they can add information about three BRCA mutations to the health reports they issue.

Approval of this testing a big step forward in the availability of genetic tests for consumers, but there are more than 1,000 BRCA mutations and this test does not screen for the ones that are most commonly associated with a higher risk of cancer in Americans.

Experts are also warning consumers and doctors not to use the test results to make any treatment decisions and that a negative test does not mean they don’t have other genetic or lifestyle factors that could increase their risk of cancer.

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