Laboratory Industry Split on Anticipated Impact of FDA’s LDT Regulation Framework

The laboratory industry has now had a few weeks to mull over the U.S. Food and Drug Administration’s (FDA’s) framework for increasing its regulation of laboratory-developed tests (LDTs), and the reaction is decidedly mixed. Commercial diagnostics companies are projecting a much more optimistic tone, with analysts noting public testing companies have been factoring an increased regulatory environment into their strategies and are well-positioned to make the transition. Directors in the academic and hospital laboratory sector, on the other hand, have said the outlined framework is a “nightmare” that will have a “crippling” effect on their operations and will negatively impact clinical laboratory care. DTET spoke to stakeholders throughout the industry to better understand the anticipated impact of the expanded regulation. Evolution of LDTs Raised FDA Concern “While CLIA oversight has played an important role in ensuring clinical labs are operating appropriately, it has not necessarily ensured that LDTs are properly designed, consistently manufactured, and are safe and effective for patients,” writes Philip Desjardins, former FDA lawyer and current counsel at Arnold & Porter (Washington, D.C.) in an August advisory. The need for oversight, the FDA believes, stems from the perceived increasing risk patients face resulting from the expanded complexity and […]