CDRH Steps Up Vigilance of Genetic Testing Product Sector

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued letters to American International Biotechnology Services, Lumigenix and Precision Quality DNA questioning their direct-to-consumer advertising practices given their IVD products have not been cleared by the agency.

In the letters, the CDRH has requested meetings with each manufacturer to determine whether their products—an in-home collection kit from American International Biotechnology Services, a genetic testing kit from Lumigenix, and a genetic testing kit from Precision Quality DNA—require review processes by the FDA in order to be legally marketed in the US. The firms have 15 days to reply to the agency’s inquiries.

Taken in a broader context, the CDRH’s move could indicate either increasing attention to the burgeoning at-home genetic testing product sector or greater vigilance against direct-to-consumer advertising of products that have not received FDA review—or both. The regulatory outcomes for these three firms could indicate how the FDA will treat other such manufacturers marketing similar devices going forward.

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