23andMe gets FDA approval for BRCA cancer risk DNA test

FDA OKs direct-to-consumer test for certain types of breast cancer mutations

The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. This week, the FDA approved the genetic test by the company, 23andMe, which is part of its $199 Health and Ancestry product.

This test is far from definitive: There are thousands of mutations on the BRCA genes alone that can raise a person's risk of developing cancer, and 23 andMe's test can only identify three. Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement that the utility of the test lies in offering information to a specific population that otherwise might not get genetic screening.

The Food and Drug Administration just approved an at-home test that allows people to check their risk of breast cancer themselves.

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The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. Any person who comes back with a negative for these three gene mutations, for example, could still carry other mutations in the BRCA genes that elevate their cancer risk. But those mutations are not the most common BRCA mutations in the broader population.

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. The agency also noted that a majority of cancers are caused by lifestyle factors, such as smoking, obesity, hormones, and other habits.

The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. The agency also outlined special controls created to assure test's accuracy and reliability. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood.

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