FDA Gives 23andMe Approval To Check For BRCA Mutations

FDA Gives 23andMe Approval To Check For BRCA Mutations

Those decisions should be based on confirmatory tests and genetic counselling.

Cautions on what the testing indicates were issued by both 23andMe, which is particularly popular for its ancestry testing, something that can be subjective, too, as well as the FDA.

Limited test: There are more than 1,000 known mutations found on BRCA genes, and 23andMe's test doesn't yet look at the most common ones in the general population. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk".

"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer", Anne Wojcicki, CEO and cofounder, said in a press release. "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement.

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"The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk", he said.

The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries. The American Cancer Society says this year, it will be diagnosed in 260,000 women and a few men, and will kill almost 41,000.

In a blog post, the American Cancer Society's chief medical officer, J. Leonard Lichtenfeld, said people with strong family histories of cancer could be misled by apparently reassuring results on such a limited test: "In short, you might be led to think you are off the hook, when the hook is still very much intact".

The test will report on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women-as well as breast cancer in men-by analyzing DNA from a self-collected saliva sample. For the first time, the agency authorized 23andMe's test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews. To win approval, the company submitted data showing its instructions and reports are easy to understand. Women who carry any of these mutations have a 45% to 85% breast cancer risk. It can not determine a person's overall risk of developing cancer.

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