The Association for Molecular Pathology wins a legal victory as a U.S. District Court vacates the FDA’s rule on laboratory-developed test regulation, protecting innovation and patient care.
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| The U.S. District Court has ruled in favor of the Association for Molecular Pathology, vacating the FDA’s regulation on laboratory-developed tests, safeguarding patient care. |
Rockville, Maryland, USA — March 31, 2025:
The Association for Molecular Pathology (AMP) secured a major legal victory on Monday as the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed test (LDT) procedures as medical devices.
Judge Sean D. Jordan granted AMP’s motion for summary judgment, marking a significant win for molecular diagnostic professionals and patients across the country. AMP President Jane S. Gibson hailed the ruling as a decisive rejection of what she called “unwarranted overreach” by the FDA. “This judgment is a significant victory for our members and for patients across the country,” she said. “The decision will prevent billions in unnecessary healthcare costs and ensure continued access to high-quality care.”
LDTs play a crucial role in diagnosing rare and infectious diseases, oncology biomarker testing, and human genomics. Unlike medical devices, they are designed and performed within highly regulated clinical laboratories and adapted to evolving medical needs.
Eric Konnick, chair of AMP’s Professional Relations Committee, emphasized that the FDA’s rule would have placed unnecessary burdens on clinical laboratories, increasing costs and complicating patient care. “AMP members continue to work with stakeholders on a framework that enhances oversight while preserving innovation and patient access,” he said.
AMP has long argued that existing Clinical Laboratory Improvement Amendments (CLIA) regulations provide sufficient oversight for LDTs. The organization’s legislative proposal seeks to refine this framework while maintaining flexibility for scientific advancements.
Founded in 1995, AMP represents over 3,100 experts in molecular diagnostics, spanning bioinformatics, infectious diseases, oncology, and inherited conditions. The organization plays a pivotal role in shaping policy and ensuring access to cutting-edge diagnostic tools.
This ruling marks a significant moment in the ongoing debate over regulatory oversight in molecular diagnostics, reinforcing the role of medical experts in driving patient-centered innovation.