Direct-to-consumer cancer risk test gets FDA approval

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

Test For Breast Cancer Gene Will Be Available In Weeks The FDA approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer.

The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.

"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", said Anne Wojcicki, 23andMe CEO and co-founder, in a press release.

According to the National Cancer Institute, the three mutations are present in ~2% of Ashkenazi Jewish women compared to 0 - 0.1% in other populations. The test only detects three out of more than 1,000 known BRCA mutations. The variants also are associated with ovarian cancer in women and breast and prostate cancer in men. Those most at risk of developing such cancers are of Eastern European Jewish descent.

The FDA echoes the caveat. The FDA cautions that a negative result from the test doesn't rule out that a person has other BRCA mutations or an increased risk of cancer.

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They were her first major global titles and the Scot will be looking to do it again on the world indoor stage in Birmingham. It was a fine call, both on a personal level, and for a young team making significant inroads.

Consumers and health care professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries.

23andMe earned the authorization based on data showing accurate identification of these three variants in saliva. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood.

Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction".

BRCA1/BRCA2 test has been authorized by the Food and Drug Administration (FDA). These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.

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