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

The Association for Molecular Pathology has asked a Senate committee to accept a legislative proposal that would pose an alternative to FDA’s proposed laboratory developed test (LDT) framework, giving the Centers for Medicare and Medicaid Services regulatory jurisdiction over the tests under a beefed-up Clinical Laboratory Improvements Amendments law. (See Also see "FDA Releases LDT Regulatory Framework, Notification Draft Guidances" - Medtech Insight, 6 October, 2014..)

The pathologists group, one of several that expressed disappointment with FDA’s LDT framework early on (See Also see "Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility" -...