By Diagnostic World Staff
April 1, 2025 | The U.S. District Court for the Eastern District of Texas granted a motion for summary judgment yesterday, vacating the FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act.
Plaintiffs in the case included the American Clinical Laboratory Association, HealthTrackRX Indiana, and HealthTrackRX, the Association for Molecular Pathology (“AMP”) and Michael Laposata, M.D.
In a statement, AMP President Jane S. Gibson, Ph.D. said, “AMP is extremely pleased with the court’s clear and decisive ruling in our favor, and we hope this will finally end the FDA’s attempts to exert an unwarranted overreach of authority of LDTs. This judgment is a significant victory for our members and for patients across the country. The decision to vacate the FDA rule will avoid adding billions of dollars to healthcare costs and protect access to high-quality care for hundreds of millions of Americans.”
The LDT road has been long and complicated, but on Apr. 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule amending the agency’s regulations to clarify that in vitro diagnostics (IVDs), including tests made by laboratories, are considered medical devices under the Federal Food, Drug, and Cosmetic Act. In August 2024, AMP filed suit challenging the rule, citing the far-reaching and long-lasting consequences to Association members and patients.
AMP’s argument is that LDTs have led to significant clinical advancements and diagnostic breakthroughs in rare and infectious diseases, human genomics, oncology biomarker testing and more for decades. They are often created in response to recent medical advances and unmet clinical needs, and have been instrumental for early and precise diagnosis, disease monitoring and treatment guidance. LDTs are designed, developed, validated, performed and interpreted by highly trained medical and scientific experts in regulated clinical laboratories. Importantly, LDTs are not manufactured, packaged or commercially distributed like medical devices. AMP’s more than 3,100 members practice various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions and oncology.
Eric Konnick, M.D., is AMP’s Professional Relations Committee chair and an associate professor and the associate director of the Genetics and Solid Tumor Laboratory at the University of Washington Department of Laboratory Medicine and Pathology. “The FDA LDT rule would have created an undue burden on laboratories tasked with keeping patients healthy and safe and would have led to extensive additional requirements in addition to the existing CLIA regulations,” he said.