The regulatory landscape for laboratory-developed tests (LDTs) has shifted more in the past 18 months than in the previous decade. This morning’s AMP 2025 breakout session “LDTs Under the Microscope: Regulatory and Legislative Updates” brought clarity, context, and a clear call to action for labs, clinicians, and diagnostics companies navigating a rapidly evolving environment.

A major victory—but not the end of the story

The session opened with what AMP leaders called “a great victory, but not the end of the threats.” That victory, of course, was Judge Jeremy Jordan’s March 31, 2025 decision vacating the FDA’s sweeping 2024 final rule, which would have treated many LDTs as medical devices under 21 CFR 809.3. AMP, joined by the College of American Pathologists (CAP), the Association for D

See Full Page