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

Personal genetics company 23andMe announced yesterday that it's received the first-ever FDA authorization for genetic testing for cancer risk

According to a release by the company, the authorization "allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer." 

The new features will not come with an increase in cost to the kit's existing $199 price tag.

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“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. “We believe it’s important for consumers to have direct and affordable access to this potentially life-saving information. We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to health care.”

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. "The variants may also be associated with an increased risk for certain other cancers. These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants. Women with one of these variants have a 45–85 percent chance of developing breast cancer by 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."

“This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests. 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. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test. 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.”