The pathologist served as joint plaintiff in a lawsuit challenging FDA regulation of LDTs as medical devices.
The Association for Molecular Pathology (AMP) has awarded Michael Laposata, MD, PhD, its Champion for Innovation Award in recognition of his contributions to clinical laboratory practice and his role as joint plaintiff in the organization’s lawsuit against the US Food and Drug Administration’s (FDA) laboratory-developed test (LDT) regulation.
The award will be presented in November during the AMP 2025 Annual Meeting & Expo in Boston. Earlier this year, the US 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.
Laposata is a professor and former chair of the Department of Pathology and director of the MD-PhD program at the University of Texas Medical Branch at Galveston. Previously recognized by The Pathologist as the most influential pathologist in the US, he has published more than 200 peer-reviewed articles and received 14 major teaching awards at Harvard University, Massachusetts General Hospital and the University of Pennsylvania School of Medicine.
“AMP is grateful for Dr Laposata’s unwavering commitment to improving clinical laboratory practice and willingness to be a joint plaintiff in our suit against the FDA,” says Jane S. Gibson, PhD, AMP president and chair of the Department of Clinical Sciences at the University of Central Florida College of Medicine, in a release. “Thanks to our combined efforts and the US District Court’s decision, we have been able to preserve diagnostic innovation, avoid escalating healthcare costs, and continue to ensure widespread patient access for these essential medical services.”
LDT Regulation Background
LDTs have been instrumental in advancing diagnostics for rare and infectious diseases, human genomics, oncology biomarker testing and other areas. These tests are designed, developed, validated, performed and interpreted by trained medical and scientific experts in regulated clinical laboratories, and are not manufactured, packaged or commercially distributed like medical devices.
AMP has maintained that the best approach to ensuring continued development of accurate and reliable LDT procedures is through clarification of current Clinical Laboratory Improvement Amendments regulations rather than FDA device regulation. The organization’s legislative proposal builds on existing oversight frameworks and offers test quality enhancements where appropriate.
Laposata earned his MD and PhD from Johns Hopkins University and completed a fellowship and residency in laboratory medicine at Washington University School of Medicine. He is the author of Laposata’s Laboratory Medicine, now in its fourth edition.
AMP, founded in 1995, represents more than 3,100 members practicing molecular diagnostics across disciplines including bioinformatics, infectious diseases, inherited conditions, and oncology.
Photo caption: The Association for Molecular Pathology awarded Michael Laposata, MD, PhD, its Champion for Innovation Award. Laposata was recognized for his contributions to the clinical laboratory field and for his role as a joint plaintiff in AMP’s successful lawsuit challenging the US Food and Drug Administration’s rule on laboratory-developed test procedure regulation. The award will be presented in November during the AMP 2025 Annual Meeting & Expo in Boston.
Photo credit: University of Texas Medical Branch at Galveston
