Five years after a crackdown on direct-to-consumer (DTC) genetic testing companies that in 2013 temporarily shut down Google-backed 23andMe in the U.S., the Food and Drug Administration (FDA) is now finalizing a plan to speed regulatory approval of DTC genetic testing that could help fuel a testing boom. The agency is building on its approval of 23andMe’s carrier screening test for Bloom syndrome in 2015 and 10 genetic health risk assessment tests in April 2017 that included late-onset Alzheimer’s and Parkinson’s disease.
However, at the same time that FDA is opting for a lighter touch on DTC genetic testing services, these companies have caught the eye of leaders in Congress. Senate Minority Leader Chuck Schumer (D-NY) has called on the Federal Trade Commission to investigate the privacy policies of DTC companies and ensure that they have “clear, fair privacy policies and standards.” He emphasized that some companies have included in their consent agreements permission to share data with third parties.
The senator’s comments came after FDA issued a final notice classifying what it calls genetic health risk assessment tests as class II devices. Importantly, FDA now feels confident in expanding this approval to all comers after a one-time, per-company checkup. “The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation, as these technologies don’t fit squarely into our traditional risk-based approach to device regulation,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
Under FDA’s new approach, after companies obtain clearance for a genetic health risk assessment test system they will be able to offer new tests directly to consumers without notifying the agency. FDA does spell out, however, detailed requirements for how companies must educate consumers about the benefits and risks of testing, what test results mean, and how to seek the help of a genetic counselor.
The interest in DTC genetic testing comes at a time when companies are expanding sales beyond the niche market in which they began. A discounted kit from 23andMe for health and ancestry testing was in the top five best-selling items from Amazon on Black Friday during the 2017 holiday shopping season, just behind a Wi-Fi smart plug and the Instant Pot pressure cooker. 23andMe, Ancestry, and more than a dozen other companies all sell test kits on Amazon.