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Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan

This article was originally published in The Gray Sheet

Executive Summary

The Association for Molecular Pathology wants a Senate panel to consider a legislative alternative to FDA’s proposed lab developed test (LDT) framework, a plan to modernize the Clinical Laboratory Improvement Amendments Act and let CMS or a third party assess high-risk LDT procedures for clinical validity.


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