Public interest group welcomes regulation of direct-to-consumer genetic tests
The Center for Genetics and Society says FDA letters will help protect consumers
The Center for Genetics and Society, a nonprofit policy research and advocacy organization, welcomed today’s announcement of a federal agency’s intention to regulate the controversial direct-to-consumer (DTC) genetics testing industry.
“Along with other observers, we’ve long said that some of these tests are tantamount to practicing medicine,” said Jesse Reynolds, a policy analyst at the Center. “Today, the US Food and Drug Administration concurred, announcing its intention to classify the tests as medical devices.”
The FDA sent letters to DTC companies and one laboratory equipment manufacturer. In those to the DTC companies, the letters concluded, “Consumers may make medical decisions in reliance on this information.”
“For too long, the direct-to-consumer genetics industry has tried to have it both ways: advertising the medical importance of their tests’ information, but burying disclaimers that the tests are for ‘recreational’ or ‘educational’ purposes only,” Reynolds added. “Some genetic tests can provide beneficial information, particularly in a clinical setting. But some direct-to-consumer gene tests are little better than snake oil. The FDA letters are steps toward protecting consumers and providing clarification for the industry.”
Medically relevant tests offered by DTC companies include those for genes related to sensitivity to prescription drugs, such as warfarin, and for genes linked to increased chances of developing serious, late-onset health conditions, such as cancer.
The Center for Genetics and Society is a non-profit public affairs and policy advocacy organization working to encourage responsible uses and effective societal governance of human genetic and reproductive biotechnologies.