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US FDA Implements 'Firm-Based' Regulatory Approach To DTC Genetic Health Risk Tests

 
• By Sue Darcey

Formalizing an approach applied to oversight of 23AndMe's direct-to-consumer genetic health risk tests, US FDA Nov. 6 said it plans to allow DTC testing services to be exempted from pre-market review after each individual maker of such an offering comes to the agency for a one-time review to ensure it meets FDA requirements.

US FDA said Nov. 6 it is implementing a novel "firm-based regulatory approach" to overseeing consumer genetic health risk (GHR) tests that it initiated in April when it allowed 23andMe Inc., to launch the first FDA-validated direct-to-consumer tests predicting individuals' predisposition to genetic diseases and conditions.

The April 6 determination paved the way for FDA's formalization this week of its de novo classification of GHRs as...

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