FDA warns home genetic test makers on medical claims

May 16, 2011 by MassDevice staff

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.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.