Summary:
A federal court ruled in favor of the Association for Molecular Pathology (AMP), striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices, marking a major win for clinical labs and patient access to diagnostics.
Takeaways:
- Court Victory: AMP and Dr. Michael Laposata won their lawsuit, with the court vacating the FDA’s LDT rule as overreach.
- Impact on Healthcare: The ruling prevents added regulatory burdens and costs, protecting patient access to vital diagnostics.
- Future Oversight: AMP advocates for updating CLIA regulations instead of FDA control to ensure quality and innovation in LDTs.
The Association for Molecular Pathology (AMP), a global molecular diagnostic professional society, and pathologist Michael Laposata, MD, PhD, announced a favorable ruling in their lawsuit against the U.S. Food and Drug Administration over the regulation of laboratory-developed test procedures. The ruling by Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas granted AMP’s motion for summary judgment and vacated the FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act.
“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,” says AMP President Jane S. Gibson, PhD, a Pegasus-awarded professor of pathology, chair of the Department of Clinical Sciences and director of molecular diagnostics at the University of Central Florida College of Medicine. “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.”
LDTs Have Led to Significant Clinical Advancements
For decades, LDTs have led to significant clinical advancements and diagnostic breakthroughs in rare and infectious diseases, human genomics, oncology biomarker testing and more. 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.
“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,” says 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. “AMP members continue to work with key stakeholders to develop a more effective and efficient legislative framework that clarifies oversight, enhances transparency, preserves innovation, avoids escalating costs and ensures widespread patient access for these essential medical services.”
AMP: Best Path Is Clarifying CLIA Regs
AMP has long maintained that the best approach to ensuring the continued development and deployment of accurate and reliable LDT procedures—and the correct utilization, precise interpretation and proper application of molecular test results—is through clarifying the current CLIA regulations. AMP’s legislative proposal builds on the existing oversight framework and offers test quality enhancements where appropriate.
To read the full ruling, please visit the AMP website.
Featured Image: Fernando Gregory | Dreamstime.com
