FDA authorized direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

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On Mar. 6, 2018, the U.S. Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It was the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent.

The test analyzed DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.

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Source: U.S. Food and Drug Administration
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