FDA approves 23andMe test for breast cancer gene mutations

The FDA has approved a test for genetic predisposition to breast cancer that can be taken at home from the popular DNA testing company 23AndMe. Inside the labs at 23AndMe in Mountain View, California, technicians are processing thousands of saliva samples, all of them from people who used the take home kit to get genetic information about their ancestry or health.

"The test that we offer is a great way for those people to get access to the information directly without having to get a prescription," Emily Drabant Conley, Ph.D, VP of Business Development at 23andMe, told CBS San Francisco.

The company has long offered DNA testing to learn more about ancestry. Now, for the first time the FDA is allowing the company to start testing for specific genetic mutations linked to breast cancer risk.

The 23AndMe test will only screen for three possible breast cancer mutations that are mostly seen in a very small percentage of the population.

"They are applicable primarily to people of Ashkenazi Jewish ancestry, so that's an important limitation of the test," Drabant Conley said.

That's something Stanford University medical ethics professor David Magnus worries will confuse users.

"People will misunderstand and believe that because they test negatively, that is, they don't test positive for any of the three BRCA [breast cancer-related] genes that are being tested by the company, that that means they have a clean bill of health," he said.

He said he worries someone could still have another one of the thousands of gene mutations that aren't covered by the take-home kit.

"For some people who might be getting this test, it might be harder to really interpret and understand those results," Magnus said.

But company representatives say it's something they've worked through with the FDA.

"23andMe has had to show that people could understand this information receiving it directly rather than receiving it through a health care provider," the company said in a statement.

In a statement, 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, states that "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."

The testing kit will be available in the next couple of weeks on the 23andMe website. The cost is $199.

The BRCA test is part of a whole genetic kit that tests your heritage and overall health info. To get the BRCA results, you have to opt in; it is not automatic. The results take 6 to 8 weeks.