Put It on the Board
April 2025—The U.S. District Court for the Eastern District of Texas ruled on March 31 in favor of the laboratory plaintiffs in the two consolidated cases challenging the validity of the Food and Drug Administration’s final rule on laboratory-developed tests. The plaintiffs in the cases were the American Clinical Laboratory Association, Association for Molecular Pathology, HealthTrackRX and HealthTrackRX Indiana, and pathologist Michael Laposata, MD. The ruling by Judge Sean D. Jordan ordered that the plaintiffs’ motions for summary judgment be granted. The final rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act was vacated.