In a landmark decision, the Federal Drug Administration (FDA) has approved the first ever breast cancer genetic test developed by leading at-home genetics company, 23andMe. People will now have the ability to test themselves at home for genetic risk factors connected to ovarian and breast cancer without their doctor’s permission. The approved at home genetic test will look for three mutations of the BRCA1 and BRCA2 genes.

While the news of an at home BRCA test is exciting, we should take notice of the cautions and stipulations that came with the FDA’s announcement.

The Test is Not a One Size Fits All

While the test does look at 3 mutations, there have been over 1,000 mutations of the BRCA1 and BRCA 2 genes identified so far. On top of that, the mutations tested for in the 23andMe test are not very common and according to the FDA only found in about 2% Ashkenazi Jewish women.

In a press release from 23andMe, they do look at this authorization as an important step in the right direction. Christine Pai, communications manager at 23andMe, told Newsweek that people who carry one of these three mutations have up to an 85% chance of developing breast cancer before 70.

Experts Caution About Using Test For Health Decisions

The FDA stated in their press release that citizens should not use this test to make substantial healthcare decisions. The U.S. Preventive Services Task Force recommended against testing for BRCA in women who do not have a family history of breast or ovarian cancer.

​“While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of American carry one of these three mutations, and most BRCA mutations that increase an individual’s risk are not detected by this test.”
​Donald St. Pierre – Director of Office of In Vitro Diagnostics and Radiological Health

The CEO of 23andMe, Anne Wojcicki, does echo the concerns of the FDA. She believes it is important to understand that the majority of cancer is not hereditary. The 23andMe test does not look for all the genetic variants of BRCA, and people should continue with recommended cancer screenings.

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