A new 56-page article about "The Wild Wild West" of LDTs, by legal scholar John Gilmore. Find it online at Washington & Lee Law Review, here:
https://scholarlycommons.law.wlu.edu/wlulr-online/vol81/iss4/1/
Regardless of test development paradigms, Gilmore focuses his discussion on issues regarding misleading or excessive claims.
AI Corner
While Gilmore's abstract is easily available at the link above, here's a Chat GPT 50 word summary.
- Gilmore's article discusses the regulation and concerns surrounding Laboratory Developed Tests (LDTs), focusing on liquid biopsy tests for cancer detection. It outlines the challenges posed by the lack of comprehensive regulation under current U.S. law, specifically under the FDA and CMS frameworks, leading to potential risks to public health.
- The document highlights the need for a multi-faceted approach to address these issues, including revising legislation, applying specific court decisions, and expanding FDA regulatory power. This approach aims to balance the benefits of LDTs in healthcare with the need for public protection and the encouragement of research and development in diagnostic testing.
