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Lab Professionals Oppose Draft Dx Reform Bill; Lab, IVD Industry Ready To Work With Congress

 
• By Sue Darcey

The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.

PCR strip test tubes and micropipette in genetics laboratory. Toned photo

Clinical laboratory professional groups are largely opposed to House discussion draftlegislation that would combine in vitro diagnostics and laboratory-developed test services (LDTs) into one, new regulated product category overseen by US FDA and the Centers for Medicare and Medicaid Services.

Meanwhile, the clinical laboratory industry appears to support the new approach but wants some changes to the draft. And IVD...

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