23andMe Has Received FDA Approval to Tell You About Your Breast Cancer Risk

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23andMe Test Kit

23andMe Test Kit

23andMe has received the first-ever FDA authorisation for a direct-to-consumer genetic test for cancer risk for its BRCA1 and BRCA2 report. 

This will allow 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer. These variants are most common in people of Ashkenazi Jewish descent.

“Being the first and only direct-to-consumer genetics company to receive FDA authorisation to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer,” said Anne Wojcicki, 23andMe CEO and co-founder.

“We believe it’s important for consumers to have direct and affordable access to this potentially life-saving information. We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to health care.”


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A Step Forward in the Availability of Direct to Consumer Genetic Tests

The concept of an at-home BRCA test may be exciting, but the FDA’s announcement came with a host of caveats.

The test analyses 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. The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.


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“While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test,” acting director of the FDA’s Office of In Vitro Diagnostics and Radiological Health said in a press release. “The test should not be used as a substitute for seeing your doctor for cancer screenings or counselling on genetic and lifestyle factors that can increase or decrease cancer risk.”




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