Congress May Soon Act on LDT, IVCT Regulation

Major changes in regulation of LDTs have the attention of many labs, IVD manufacturers

CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tests under CLIA while calling …

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