Policy & Legislation
News on government policy and legislation impacting life science and diagnostics.
International Consensus Statement Says Microbiome-Based Diagnostic Tests Not Ready for Prime Time
Researchers laid out a set of ethical, organizational, and technical guidelines for the development, commercial use, and clinical implementation of microbiome tests.
Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
Association for Molecular Pathology 'In Limbo' as FDA Lawsuit Moves Ahead, LDT Regulations Loom
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At the AMP annual meeting this week, leadership briefed members on what to expect as its lawsuit challenging the FDA final rule on laboratory-developed test regulation unfolds.
While Congress has protected labs from PAMA cuts via a series of one-year delays, this has locked lab prices at 2016 levels, heightening the urgency for a permanent fix.
Retirements and the outcomes of a handful of close races could reshape congressional committees tasked with oversight of issues important to labs.