FDA Gives 23andMe Approval To Check For BRCA Mutations

08 March, 2018, 02:03 | Author: Inez Murphy
  • 23andMe image

In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription.

The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer.

This test analyzes a sample of saliva and screens for three mutations of the BRCA1 and BRCA2 genes.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations. They could also face elevated breast cancer risk due to other gene variations or other factors. Due to the prevalence of other mutations, the test can not determine overall cancer risk, according to the FDA. 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%.

The FDA's director of the Office of In Vitro and Radiological Health, Donald St. Pierre noted that the test has a lot of caveats. Now they can add information about three BRCA mutations to the health reports they issue.

The FDA approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer. In addition to testing, it is important for patients to discuss cancer risk related to lifestyle factors with their providers, according to the release. The test was reviewed through the de novo premarket review pathway. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer. At this time, the FDA is also establishing special controls that outline the agency's expectations for accuracy, reproducibility, clinical performance, and labeling. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found.

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