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Companion Diagnostics Guidance Finalized, But Lab Test Enforcement To Be Key

 
• By David Filmore

FDA makes very few revisions from its three-year-old draft, but simultaneously releases the much-delayed proposal to begin actively regulating lab-developed tests, which presents important underlying questions for personalized medicine.

FDA’s final guidance on in vitro companion diagnostic devices, posted July 31, does not include any big changes from the 2011 draft, but the agency’s parallel unveiling of a planned framework for regulating laboratory-developed tests provides some significant new context.

The companion diagnostic document is intended to provide basic guidelines on submissions and approvals for diagnostics that are considered “essential”...

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