FDA Issues Warning Letters to 3 Makers of DTC Gene Tests
5/17/2011 9:12:47 AM
The FDA warns a trio of companies that offer direct-to-consumer genetic tests on medical claims made in their marketing campaigns. The FDA formally warned three providers of direct-to-consumer DNA tests about medical claims the companies make that the federal watchdog agency hasn't approved. The FDA wants the companies; American International Biotechnology Services, Lumigenix Inc and Precision Quality DNA — to either furnish evidence of device approval or make a case that their products don't fall under the FDA's purview.