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.
American International Biotechnology Services (formerly CBI Services) sells a Sports X Factor Test Kit it claims can predict the risk for certain health conditions, including undiagnosed heart conditions. The FDA issued a warning letter to the Richmond, Va.-based company, asking for clearance or approval numbers to demonstrate that the claims were reviewed.
The letters follow an independent FDA panel advisory that doctors be involved with the use of personal genetic tests.
Lumigenix Inc recieved a similar warning for advertising that its tests uncover genetic risk factors for 79 diseases. Lumigenix’s marketing touts its ability to uncover heightened risk for everything from lactose intolerance to ovarian cancer. The Palo Alto, Calif.-based company said it plans to cover more than 70 new diseases and traits by the end of the year.
Precision Quality DNA of Fallon, Nev., calls itself a “DNA Guidance service,” warning consumers to “dodge the bullet with your name on it.” The FDA expressed concerns about Precision Quality’s claims to provide insight into individual’s likely reponse to specific drugs and promises to highlight risk factors based on main target genes.