FDA Okays Genetic Home Test for Cancer

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This week, the U.S. Food and Drug Administration (FDA) authorized 23andMe to market the first direct-to-consumer test for three specific genetic mutations known to increase the risk for breast, ovarian, and prostate cancer.

Called the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants), the test analyzes DNA from self-collected saliva samples to detect three out of more than 1,000 known BRCA mutations known to increase the risk for breast, ovarian, or prostate cancer. These three BRCA genetic mutations are most commonly found in people of Ashkenazi (Eastern European) Jewish descent.

The FDA also issued some notes of caution: Negative test results do not rule out other BRCA mutations that raise cancer risk, and consumers should not make treatment decisions based on the 23andme test results. Consult with your doctor whether your test results are positive or negative.

Sourced from: FDA