The U.S. Food and Drug Administration (FDA) granted marketing authorization to 23andMe (Mountain View, Calif.) for its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2—genetic mutations known to be associated with higher risk of breast, ovarian, and prostate cancers. It is the first authorized direct-to-consumer (DTC) genetic test for cancer risk, but the FDA authorization came with special controls that require labeling to indicate the tests’ limitations. The test only assesses three of more than 1,000 known BRCA mutations, meaning that a negative test result does not rule out an increased cancer risk. The three mutations examined in the DTC test are most common in people of European Jewish descent; yet only represent a very small minority (2 percent) of hereditary cancer mutations even in this population. According to a National Cancer Institute study, these mutations rarely occur (0 percent to 0.1 percent) in other ethnic populations. A Summary of 23andMe’s Authorizations February 2015: Authorization enabled the company to launch 40+ carrier status reports directly to customers. April 2017: Granted the first authorization by the FDA to enable DTC genetic health risk reports. To date the company has launched nine reports conditions, including late-onset Alzheimer’s disease, Parkinson’s disease, celiac […]