Genentech Petitions FDA to Regulate All Predictive LDTs, Provide Greater ‘Clarity’

In a Citizen Petition filed Dec. 8, Genentech states that given the “recent proliferation” of lab-developed tests making “unsubstantiated and … inaccurate or misleading claims,” it is “critical” for FDA to regulate all such tests and to “provide much needed clarity” over its regulatory plan.

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