Update on the Regulation of Laboratory Developed Tests - MDUFA and LDTs

Explore the regulatory landscape of Laboratory Developed Tests (LDTs) in this 32-minute invited presentation from the 2022 Cancer Genomics Consortium Annual Meeting. Delve into the impact of the Medical Device User Fee Amendments (MDUFA) on LDT regulation, guided by moderator Thuy Phung and presenter Eric Konnick. Gain insights into the current state of affairs, legislative developments in the House and Senate, and pre-conference discussions. Examine potential outcomes if legislation fails to pass, environmental factors influencing regulation, and actionable steps for stakeholders. Conclude with a comprehensive summary of key points, equipping yourself with crucial knowledge about the evolving regulatory framework for LDTs in cancer genomics and molecular diagnostics.