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.
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