Association for Molecular Pathology to Provide Preliminary Analysis of the FDA’s Final Rule on Laboratory Developed Testing Procedures

ROCKVILLE, Md. – May 6, 2024 – The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, will host a free webinar on the US Food and Drug Administration (FDA) final rule that seeks to regulate  laboratory developed tests (LDTs) as medical devices. The webinar will provide a preliminary analysis of the rule and its implications on clinical practice and patient care.

“AMP is very disappointed with the FDA’s continued attempts to overstep its authority and bypass the legislative process in the United States,” said Laurie Menser, CEO of AMP. “This rule is a drastic policy change that will have wide-sweeping and long-lasting consequences for not only our members, but for patients across the country. AMP will continue to ensure our membership is informed while we meet with other clinical laboratory organizations and key stakeholders to carefully evaluate our options and coordinate our next steps.”

WHAT:   AMP Webinar on FDA Final Rule: Medical Devices; Laboratory Developed Tests

WHEN:  May 9, 2024, at 1:00 pm ET

WHO:    Eric Konnick, MD, Chair of Professional Relations Committee at AMP

               Annie Scrimenti, Associate Director of Public Policy and Advocacy at AMP

HOW:    To register in advance:     

               https://us06web.zoom.us/webinar/register/WN_dZfbmeylRvurzXIsvxQvQQ#/registration

AMP has long maintained that the involvement of appropriately trained and qualified laboratory professionals is critical to the development of accurate and reliable laboratory developed testing procedures, as well as for correct utilization, precise interpretation, and appropriate application of molecular test results. Rather than radically overhauling the existing oversight mechanisms, the AMP proposal modernizes the current Clinical Laboratory Improvement Amendments (CLIA) regulation program and provides assurance of quality, analytical validity, and clinical validity. AMP believes this approach would provide a far more appropriate and efficient regulatory framework that ensures access to necessary patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies. 

ABOUT AMP

The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP’s 2,900+ members practice various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions, and oncology. Our members are pathologists, clinical laboratory directors, basic and translational scientists, technologists, and trainees that practice in a variety of settings, including academic and community medical centers, government, and industry. Through the efforts of its Board of Directors, Committees, Working Groups, and Members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest-growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high-quality, appropriate testing. For more information, visit www.amp.org and follow AMP on X: @AMPath.