Companion Diagnostics Guidance Finalized, But Lab Test Enforcement To Be Key
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.
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Association for Molecular Pathology wants a Senate panel to consider a legislative alternative to FDA’s proposed lab developed test (LDT) framework and let CMS or a third party assess high-risk LDT procedures for clinical validity.
In many ways, the year in diagnostics can be characterized as “more of the same.” The biggest newsmaker was FDA’s finally taking steps toward establishing an oversight framework for the regulation of laboratory-developed tests.
The House Energy and Commerce Committee is seeking feedback on initiatives Congress should enact in 2015 regarding regulation of diagnostics, and in particular in response to FDA's plan to regulate laboratory developed tests.