ASM Joins Effort to Overturn FDA Final Rule on LDTs
Washington, D.C.—°®¶¹´«Ã½ and several lab-focused organizations filed an amicus curiae brief on Oct. 7, 2024, in support of the American Clinical Laboratory Association and the Association for Molecular Pathology lawsuit challenging the Food and Drug Administration’s final rule on laboratory-developed tests. The brief was filed jointly with the American Association of Bioanalysts, American Society for Clinical Pathology, Association for Diagnostics & Laboratory Medicine and the Infectious Disease Society of America. The brief supports the position that the final rule be overturned.“ASM and other key stakeholders recognize that the FDA rule on LDTs will have far-reaching implications for public health, for patients and for the clinicians and laboratories that serve them,” said Allen Segal, Chief Strategy and Public Affairs Officer at ASM. “That is why we have joined this effort to support ACLA’s and AMP’s lawsuit to overturn the rule.”
In the brief, the Amici Group states the FDA’s final rule has already had "serious detrimental effects on the clinical laboratories that develop and perform these tests, and, ultimately, on the provision of care to patients who rely on these testing services for prompt diagnosis and treatment." The Amici Group argues FDA exceeded its authority by regulating LDT’s as medical devices.
In May 2024, ASM responded to the FDA’s final rule on laboratory-developed tests, highlighting concerns that the approach would stifle innovation and limit patient access. ASM emphasized the need for a flexible, risk-based framework that meets the needs of rapid infectious disease testing and protects patient access to appropriate, accurate and timely diagnostics.
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°®¶¹´«Ã½ is one of the largest professional societies dedicated to the life sciences and is composed of more than 32,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.
ASM advances the microbial sciences through conferences, publications, certifications, educational opportunities and advocacy efforts. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.
°®¶¹´«Ã½ is one of the largest professional societies dedicated to the life sciences and is composed of more than 32,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.
ASM advances the microbial sciences through conferences, publications, certifications, educational opportunities and advocacy efforts. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.
