Michael Laposata, MD, PhD, whose work in laboratory medicine has shaped both education and clinical policy over more than 3 decades, has received the 2025 Champion for Innovation Award from the Association for Molecular Pathology (AMP). The award recognizes his contributions to the clinical laboratory field as well as his role as a joint plaintiff in AMP’s successful legal challenge to a US Food and Drug Administration (FDA) rule on laboratory-developed tests (LDTs).
“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,” said AMP President Jane S. Gibson, PhD. “Thanks to our combined efforts and the US District Court’s decision, we have been able to preserve diagnostic innovation, avoid escalating health care costs, and continue to ensure widespread patient access for these essential medical services.” The award was presented Friday evening during AMP’s annual meeting in Boston.
Dr. Laposata, once named the most influential pathologist in the United States by The Pathologist, is a professor and former chair of the department of pathology at the University of Texas Medical Branch at Galveston. He also directed the institution’s MD-PhD program. Over the course of his 30-year career, he has published more than 200 peer-reviewed articles and is the author of Laposata’s Laboratory Medicine, a popular textbook now in its fourth edition. Among his many honors, he has received the Award for Outstanding Contributions in Education from the American Association for Clinical Chemistry, the Ward Burdick Award from the American Society for Clinical Pathology, and the H.P. Smith Award for Distinguished Pathology Educator from the American Society for Clinical Pathology. He earned his MD and PhD from Johns Hopkins University in Baltimore and completed his fellowship and residency in laboratory medicine at Washington University School of Medicine in Saint Louis.
AMP’s lawsuit challenged a 2021 FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. The rule would have subjected laboratories to additional regulatory requirements beyond those already in place under the Clinical Laboratory Improvement Amendments (CLIA). In January, the US District Court for the Eastern District of Texas granted AMP’s motion for summary judgment, vacating the rule. The court’s decision acknowledged that LDTs, which are developed, validated, performed, and interpreted by trained laboratory professionals in regulated clinical laboratories, differ from commercially manufactured medical devices. Dr. Laposata’s participation as co-plaintiff was central to the litigation. According to Eric Konnick, MD, chair of AMP’s Professional Relations Committee, the FDA rule would have imposed significant operational burdens on laboratories, potentially slowing test development and limiting patient access.
During the organization’s award ceremony on Friday evening, the Jeffrey A. Kant Leadership Award was presented to Alexis B. Carter, MD, a molecular genetic pathologist and physician informaticist at Children’s Healthcare of Atlanta and adjunct associate professor at Emory University. Dr. Carter has contributed to the integration of informatics in molecular pathology and the development of standards for next-generation sequencing and bioinformatics. She has held multiple leadership roles within AMP, including chairing the Informatics Subdivision, the Finance Committee, and the EHR Interoperability for Clinical Genomics Working Group. Dr. Carter is also a former fellow of Dr. Jeffrey Kant’s, for whom the award is named. Dr. Kant played a pivotal role in establishing AMP and served as the organization’s first president.
AMP’s Meritorious Service Awards were presented to Dara L. Aisner, MD, PhD, vice chair for genomic laboratory medicine at the University of Colorado, and Lawrence J. Jennings, MD, PhD, director of genomic pathology at Northwestern University. Both were recognized for their contributions to molecular laboratory procedures, committee work, and professional guidelines. Dr. Aisner has testified before Congress on FDA regulation of LDTs, and Dr. Jennings has published extensively on assay validation and clinical implementation.
“These awards are a small token of our deep appreciation for their many contributions and unwavering commitment to improving clinical practice and patient care,” said Dr. Gibson.
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