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


USA regulators have approved the first direct-to-consumer breast cancer gene test. The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population.

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

In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy.

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The approval is specifically for the Personal Genome Service Genetic Health Risk (GHR) Report for the BRCA1/BRCA2 test revealing breast, prostate, and ovarian cancer risk. The test does not identify any of the other more than 1,000 known BRCA mutations, including mutations found most commonly in the general population. "But it has a lot of caveats", said 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.

The FDA said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants.

The National Society of Genetic Counselors recommended that people should not take the test without first consulting cancer experts, saying, "Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions". "Women with one of these variants have a 45-85 percent chance of developing breast cancer by age 70". 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 data were 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. They provide information on what the results might mean and where to get additional information.