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First At-Home Test for Breast Cancer Gene Approved by the FDA

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You might remember how Angelina Jolie opted to have a preventive double mastectomy back in 2013. If the name "BRCA" is ringing a bell, that might be why; the award-winning actress said she made her medical choice based on the fact that she carried a BRCA1 gene — which put her at an estimated 87 percent risk of developing breast cancer. Now, the first direct-to-consumer test for the BRCA genes — which increase the risk of breast and ovarian cancer — has been approved by the US Food & Drug Administration (FDA). It’s a much-needed step forward in breast cancer screening, but there are still some important caveats.

The test for the BRCA1 and BRCA2 genes is from the company 23andme — a genetic service that offers DNA testing and analytics — and it uses a saliva sample to get results. However, it's crucial to keep in mind that these results don't tell the whole story; the test only looks at three out of more than 1,000 known BRCA1 and BRCA2 mutations. So just because a woman doesn't carry those three specific kinds of mutations does not mean that it's impossible for her to be at a heightened risk for breast cancer.

“A negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk," the FDA warns.

In regard to the three BRCA genes that are being tested, they are most common in people with Ashkenazi (Eastern European) Jewish ancestry. Women who carry one of these mutations have a particularly elevated risk for developing breast cancer.

If you know that you have Ashkenazi ancestry, then this new test is "not too bad as a screen," according to Robert Cook-Deegan, a scholar in genomics ethics and law. But if you're not part of that demographic, it may not help you. Even if you know for sure you have that heritage, keep in mind that the FDA has also warned that people should not use these test results to make decisions about any treatment — including major surgeries. Additionally, it's also worth mentioning that 23andme has had some controversy over the years for selling genetic information to third parties.

That said, the new BRCA test will be part of 23andme’s $199 Health + Ancestry test. Customers who already use the service can choose to receive BRCA info for no extra cost — but they, along with new customers, must specifically choose to receive the information.

Next, learn about breast cancer signs that aren't a lump in the video below:

h/t Scientific American

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