Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan
This article was originally published in The Pink Sheet Daily
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.
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Senators are drafting legislation to create a standalone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.
Laboratory groups, who are facing the prospect of a new regulatory scheme in FDA’s proposed lab-developed test framework, intend to discuss barriers to test accessibility and clinical validation of LDTs.
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.