23andMe DNA kit lets you test breast cancer risk from home

Lydia Fleming
March 8, 2018

"These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement. Only a small percentage of Americans carry one of the three mutations, and most of the 1,000 known BRCA mutations that increase an individual's cancer risk are not included in the test. Results also should not be used to guide treatment such as surgery or hormones, the FDA said.

The U.S. Food and Drug Administration (FDA) has cleared 23andMe to launch a direct-to-consumer DNA test for gene mutations connected to various forms of cancer.

23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk.

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The agency stressed that this test should not be used as a replacement for a visit to the doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction".

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These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities.

The three variants of the gene are found most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one.

"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued. As with the first 10 tests, the company is authorized to provide the results directly to the customer. The test was reviewed through the de novo premarket review pathway.

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Topol's warning reflects an FDA letter sent to the service back in 2013, urging 23andMe to discontinue marketing its Saliva Collection Kit and Personal Genome Service.

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