23andMe gets FDA approval for BRCA cancer risk DNA test

23andMe gets FDA approval for BRCA cancer risk DNA test

For the first time the FDA has granted permission to market a direct-to-consumer genetic test to check for BRCA mutations that are associated with breast and ovarian cancer. The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population.

What it does: The test, which will be available through 23andMe's $199 health and ancestry service, reports three genetic variants found on the BRCA1 and BRCA2 genes that are most common in people of Ashkenazi Jewish descent.

BRCA1/BRCA2 test has been authorized by the Food and Drug Administration (FDA).

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The decision expands the Company's Personal Genome Genetic Health Risk (GHR) Report to now detect these breast cancer mutations.

In a prepared statement, 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, called the approval a step forward with "a lot of caveats". The test also does not provide information on a person's overall risk of developing any type of cancer. Due to the prevalence of other mutations, the test can not determine overall cancer risk, according to the FDA. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the United States, and could significantly raise the number of people aware of having the cancer-related mutations. In women, these mutations can raise the likelihood of developing breast cancer from 12% (the average baseline) to 45% to 85%, and of developing ovarian cancer from 1.3% to between 17% and 44%.

She said that although the company hasn't yet announced specific cancer risk mutations that it will add in the future, the approval surmounts a major hurdle. Additionally, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle issues. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood. The data were reviewed through the de novo premarket review pathway. The agency also outlined special controls created to assure test's accuracy and reliability.

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