Small Group of Labs, Dx Manufacturers Float Alternative to FDA LDT Guidance | GenomeWeb

NEW YORK (GenomeWeb) – Is it possible to craft a framework for regulating diagnostics that pleases everyone? A small group of labs and test manufacturers has taken a shot at it by coming up with its own proposal for regulating so-called in vitro clinical tests that it hopes will be an acceptable compromise for industry players that often disagree on the regulation of laboratory-developed tests (LDTs).

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