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
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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Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.
Patient and consumer groups urged better FDA control over modifications to marketed products and expressed support for agency oversight of laboratory-developed tests at a recent update meeting on device user fee reauthorization.
A House Subcommittee plans to take up draft legislation at a hearing next month that brings together test kits and lab-developed tests into a new regulatory category. The proposal offers many ways for tests to avoid a “high-risk” classification. “The Gray Sheet” compares the provisions to recent proposals vetted in the Senate.