23 andMe can now offer prescription-free cancer risk tests

FDA OKs direct-to-consumer test for certain types of breast cancer mutations

FDA Authorizes First Direct-to-Consumer BRCA Mutation Test

The U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk Report, by 23andMe Inc., on Tuesday, which will report on three specific BRCA1/BRCA2 breast cancer gene mutations. 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. The test can identify three specific BRCA mutations that occur most often in people of Ashkenazi Jewish descent.

According to a company statement, 1 in 40 people of Ashkenazi Jewish descent will carry one of these mutations, which for a woman confers a 45 percent to 85 percent chance of breast cancer arising by the time she reaches age 70. "But it has a lot of caveats", said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. In men, the mutations also raise the risk of breast cancer, and possibly prostate cancer as well, although the research is less clear for the latter.

23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk. The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors. The FDA expanded that today, adding breast cancer risk testing onto the approved list. The test was reviewed through the de novo premarket review pathway.

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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".

The FDA stressed that 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". These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test. Test results come in the form of a report sent to the user.

The FDA granted the marketing authorization to 23andMe.

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