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23AndMe Receives FDA Approval To Test For Breast Cancer Gene Mutations

MOUNTAIN VIEW (KPIX 5) – There's a new genetic test for breast cancer that can be taken at home, without a doctor's approval.

The test is from the popular DNA testing company 23AndMe.

So, how accurate is it?

Well, inside the labs at 23AndMe in Mountain View, 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.

Emily Drabant Conley, Ph.D works for 23andMe, and said, "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."

Now for the first time the FDA is allowing the Mountain View company to test for breast cancer mutations.

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

23AndMe only tests for three possible breast cancer mutations that are only seen in a very small percentage of the population, something medical ethics professor David Magnus worries will confuse at home users.

Stanford University bioethics Professor David Magnus, Ph.D said, "People will misunderstand and believe that because they test negatively, that is, they don't test positive for any of the 3 BRCA [breast cancer] genes that are being tested by the company, that that means they have a clean bill of health."

He worries someone could still have another one of the thousands of BRCA genes that aren't covered by the take home kit.

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

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," 23andMe said in a statement.

The testing kit will be available in the next couple of weeks on the 23andMe website. The cost? $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 and the results take 6 to 8 weeks.

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