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FDA Approves First At-Home Gene Test for Breast Cancer

Newsweek logo Newsweek 3/6/2018 Kate Sheridan

Updated | People will now be able to test themselves for genetic risk factors linked to breast and ovarian cancer at home without their doctor’s permission. The Food and Drug Administration announced on Tuesday that 23andMe’s genetic test for three mutations of the BRCA1 and BRCA2 genes has been approved.

This isn’t the first direct-to-consumer test for genetic risk factors that the FDA has allowed onto the market. 23andMe also received approval in April for a test that looks for mutations associated with the risk a person might develop 10 different diseases, including Parkinson’s.

The concept of an at-home BRCA test may be exciting, but the FDA’s announcement came with a host of caveats.

First, the test detects only three mutations—but more than 1,000 mutations of the BRCA1 and 2 genes have been identified so far. Additionally, the mutations that the 23andMe test is looking for aren’t the most common ones. According to the FDA press release, the mutations identified by the at-home kid are found in only about 2 percent of Ashkenazi Jewish women—a group that’s also more likely to carry BRCA1 and 2 mutations anyway.

“This authorization is incredibly valuable for those who might not be aware of their Ashkenazi Jewish descent or aren’t familiar with their family history of cancer,” Anne Wojcicki, 23andMe's CEO and co-founder, stated in a press release.

People who do carry one of these mutations have up to an 85 percent chance of developing breast cancer before they turn 70, 23andMe's communication's director Christine Pai told Newsweek in an e-mail. People who have already used 23andMe's health-related genetic tests will get access to a report about their BRCA mutation status as well as information to help them interpret the results "in the coming weeks," according to the company's press release. People will be able to choose if they want to know their status. 

The FDA also cautioned against using this test to make major health care decisions, like Angelina Jolie’s decision to have preventive surgery.

In fact, for women who don't have a family history of breast or ovarian cancer, the U.S. Preventive Service Task Force actually recommends against getting BRCA genetic testing done. Even for women who do have a family history, BRCA testing is best paired with a genetic counseling session.  

“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 acting director of the FDA’s Office of In Vitro Diagnostics and Radiological Health said in a press release.

Wojcicki echoed these concerns in the company's release. "[It's] important to understand that the majority of cancer is not hereditary, our test does not account for all genetic variants that can cause a higher risk of cancer, and people should continue with their recommended cancer screenings.”

This article has been updated to include more information from 23andMe's statement and about the USPSTF recommendations.

Slideshow: 14 breast cancer risk factors you should discuss with your doctor (Courtesy:


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