The Food and Drug Administration is looking to relax its regulation of genetic tests that people can order and take at home, without seeing a doctor, to figure out their risk for conditions ranging from Alzheimer's to Parkinson's to celiac disease, the agency announced today.
If the new rule goes through as planned, companies such as 23andMe would have to undergo FDA review just once, to make sure they meet the agency's standards. Should a company then make changes to its products—say, adding new genes and diseases to its tests—it wouldn't have to be reviewed again. "Our goal is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers seek," FDA head Scott Gottlieb said in a statement.
The history of 23andMe, one of the best known direct-to-consumer genetic-test companies, shows the push and pull between genetic-testing companies and federal regulatory agencies in the United States. The company at first operated with little oversight, offering a saliva test that told people whether they had the genes associated with everything from blue eyes to lactose intolerance to breast cancer. Then, in 2013, the FDA cracked down, saying the company was proffering actionable health information, which it couldn't do without FDA approval. What if somebody saw she had a breast-cancer gene, for example, and underwent invasive screening or surgery because of it? What if the test were wrong? 23andMe temporarily stopped showing health-prediction results in its test, focusing instead on ancestry and raw genetic results without interpretive statements about people's risk for different conditions. Earlier this year, the company won approval to send people test results for genes associated with 10 serious conditions.
Meanwhile, companies and customers have been waiting to see how the FDA would regulate direct-to-consumer genetic companies more generally. Today's announcement offers a glimpse into what the answer will be.