23andMe Granted FDA-Approval for Genetic Test on Cancer Risk

23andMe

The three gene mutations are most common in people of Ashkenazi (Eastern European) Jewish descent, but are not the most common BRCA1/BRCA2 mutations in the general population.

The FDA has approved a 23andMe's cancer risk test, one that provides the results directly to the consumer rather than to a doctor who would then provide their patient with info. The test looks for three mutations.

The agency stressed that this test should not be used as a replacement for a visit to the doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease 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 the U.S. Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment. As the service notes, around half of BRCA carriers who offered medical history in a study don't report cancer history among immediate relatives. The test also does not provide information on a person's overall risk of developing any type of cancer. In women, the presence of one of the variants increases breast cancer risk by up to 85 percent before age 70.

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".

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations. The agency also outlined special controls created to assure test's accuracy and reliability.

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