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FDA OKs First At-home Genetic Test for Breast Cancer Risk

U.S. regulators have approved the first genetic test a woman can take at home to check her risk of developing breast cancer — but its focus is narrow, essentially applying only to Ashkenazi Jews.

No doctor’s prescription will be needed for the test, which was developed by 23andMe.

The test assesses the three most common BRCA gene mutations found in people of Eastern European Jewish descent. The U.S. Food and Drug Administration noted that while the mutations are present in roughly 2% of these women, they rarely occur in other ethnic populations. Prevalences in non-Jews range from 0% to 0.1%.

Also, there are more than 1,000 BRCA mutations. So a negative test result, either in women of Ashkenazi Jewish descent or in other ethnic populations, does not rule out the possibility that a woman has other BRCA mutations that increase her risk of cancer.

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