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