FDA approves DNA ancestry kit to test for breast cancer gene mutations

FDA approves DNA ancestry kit to test for breast cancer gene mutations

23andMe had previously offered genetic health risk tests, but suspended them in order to get FDA approval.

The US Food and Drug Administration has approved the first home test for consumers to check breast cancer risk.

"This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests". An oncologist at Florida Hospital says these mutations are uncommon in the general population, which means that even if it comes back negative, it doesn't mean a person won't develop the disease. And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor. Women who carry any of these mutations have a 45% to 85% breast cancer risk.

According to statistics quoted in the FDA release, the three BRCA1/BRCA2 hereditary mutations detected by the test are present in about two percent of Ashkenazi Jewish women. No doctor's prescription will be needed for the test. "I think genetic testing is best used in the context of all of your ongoing medical care".

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Erica Ramos, the organization's president, said, "Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results". "You test positive for this, and all of the sudden you have this set of heavy decisions on your lap".

"In a world where people are more and more asking to see their own data, whether that's their fitness data or their blood pressure", or genetic profiles, "there is a responsibility on the part of the consumer to really think about what they are getting and take responsibility for understanding it", he said. "We believe it's important for consumers to have direct and affordable access to this potentially life-saving information".

The new features will not come with an increase in cost to the kit's existing $199 price tag. Tuesday's approval was the first for genes linked to cancer.

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