The Center for Devices and Radiological Health, under the Food and Drug Administration (FDA), has determined that 23andMe’s direct-to-consumer genetic test for selected variants of the breast cancer-associated genes BRCA1 and BRCA2 is a Class II device and is approved for immediate marketing. After review of the test, the FDA determined the test can accurately identify the specific genetic variants from a saliva sample and has reproducible results. In granting this approval, the FDA also defined a new generic category, “Cancer Predisposition Risk Assessment System for BRCA1/BRCA2 Select Variants,” for approving similar devices that may be introduced to the market in the future.
As part of its approval, the FDA established “special control” criteria to ensure safety and efficacy of the device. Broadly, the FDA is requiring measures to help the consumer understand the device, the test system, and the scope and limitations of the interpretation of the test results. Many of these controls are carried out through requirements to label the device and results with warnings and statements explaining the limitations of the device and results, and to provide hyperlinks for consumers to get more information.