Genentech Petition Rekindles Debate On Lab-Developed Test Regulation
This article was originally published in The Gray Sheet
Executive Summary
A citizen petition from biotech giant Genentech is adding new fire to the debate over whether FDA should regulate more laboratory-developed tests, and under what authority
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FDA on lab test regulation
FDA says it has not yet resolved issues raised in a Dec. 5 citizen petition from biotech firm Genentech that asks the agency to regulate all laboratory-developed tests. The petition "raises issues requiring further review and analysis by agency officials," CDRH Acting Associate Director for Regulation and Policy Catherine Cook writes in a June 15 interim response posted online July 11. Genentech is urging FDA to apply its current risk-based classification to determine the necessary level of regulatory oversight and review, and to sanction labs or firms that are selling lab-developed tests without sufficient analytical and clinical evidence to support therapeutic claims (1"The Gray Sheet" Dec. 22, 2008). FDA says it will respond with a final decision at a later date