genomeweb whitepaper

Alternative Proposals for Lab Test Regulation

Are There Opportunities for Consensus? A GenomeWeb Report February 2016 Amid multiple proposals on LDT regulation, are there opportunities for consensus? By Turna Ray The lab industry entered 2016 in a staring contest with the US Food and Drug Administration that began two years ago when the agency released its draft guidance on regulating laboratory-developed tests (LDTs). During the course …