23andMe Granted FDA-Approval for Genetic Test on Cancer Risk

08 March, 2018, 01:40 | Author: Keith Rowe
  • 23andMe

The three hereditary mutations detected by the test occur in about 2% of Ashkenazi Jewish women but are far more rare in the general population (0-0.1%).

23andMe, a company which uses a saliva sample to analyze DNA, provides information to consumers about ancestry as well as certain genetic health risks. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the U.S., and could significantly raise the number of people aware of having the cancer-related mutations. "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement.

The Food and Drug Administration just approved an at-home test that allows people to check their risk of breast cancer themselves. 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. 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. In men, the mutations also raise the risk of breast cancer, and possibly prostate cancer as well, although the research is less clear for the latter.


However, this does not find all genes that cause cancer, the FDA cautioned. About one in 40 individuals of Ashkenazi Jewish descent has one of these three variants. The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors. During the review of the test, the FDA determined that the data showed the results are accurate and provide reproducible results.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations. The agency also outlined special controls created to assure test's accuracy and reliability. The test report provides information about the results, how to interpret results, and where additional information can be found, according to the release.

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