Public interest group welcomes regulation of direct-to-consumer genetic tests

WASHINGTON The Center for Genetics and Society recently praised the Food and Drug Administration's decision to regulate the direct-to-consumer gene testing industry.

“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,” said Jesse Reynolds, a policy analyst at the nonprofit policy research and advocacy organization. “Some gene 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 typically 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.