CLSI Forms Strategic Laboratory-Developed Test (LDT) Final Rule Advisory Group

Malvern, PA—12/13/24—The Clinical and Laboratory Standards Institute (CLSI) announced today the formation of a new Laboratory-Developed Test (LDT) Final Rule Advisory Group. The group, comprising 15 respected subject matter experts in laboratory medicine and regulatory policy, is scheduled to convene for the first time in mid-December 2024

CLSI established this LDT Final Rule Advisory Group to provide perspective and guidance re CLSI’s strategic priorities in formulating an organizational response to this ruling and related regulatory changes. The group will also consult on CLSI product development to assist laboratories with implementation of the Final Rule; identification of related issues, challenges, questions, and concerns within the laboratory community; potential collaboration with other professional societies or government agencies; and interpretation of FDA guidance issued after the Final Rule. 

“We understand that this ruling has the potential to dramatically impact the important work of laboratory and clinical professionals and organizations,” said CLSI CEO Barb Jones. “The LDT Final Rule Advisory Group will deepen the impact CLSI has in supporting our laboratories during this unpredictable and disruptive period. Preparing laboratories for change – regulatory and otherwise – is at the core of our mission, and we carry that commitment forward as we navigate the Final Rule alongside the laboratory community.” 

The Advisory Group will be chaired by CLSI CEO Dr. Barb Jones and will include the following distinguished members:  

• Shannon Bennett, MS, MBA, CMQOE(ASQ), Director of Regulatory Affairs in the Department of Laboratory Medicine and Pathology at Mayo Clinic 

• Sara Blosser, PhD, D(ABMM), Senior Clinical Microbiology advisor for the Office of Laboratory Strategies and Analytics in the Clinical Microbiology and Environmental Branch of the CDC 

• Margot Borgel, PhD, Director, IVD Global Regulatory Affairs at RQM+ 

• Robert F. Klees, PhD, Research Scientist III in the Division of Translational Medicine, at the New York State Department of Health 

• Varvara K. Kozyreva, PhD, HCLD(ABB), PHM-CA(AAB), Section Chief of the Mycobacterial, Mycotic, and Parasitic Diseases Section at the Microbial Diseases Laboratory Branch of the California Department of Public Health 

• Sonia La’ulu, MBA, C(ASCP), Scientific Manager in the Research and Development (R&D) department at ARUP Laboratories  

• Kenneth Lewis, MPH, National Group Quality Director for Laboratory Services at HCA Healthcare 

• Dun Liang, PhD, Director of Regulatory Affairs at Eli Lilly 

• Dr. Mindy Nye, PhD, (MT(A SCP)), Vice President, Operations & Science Liaison in the Office of the Chief Scientific Officer at Labcorp 

• A. Joe Saad, MD, Chairperson of Pathology and Director of Anatomic Pathology at Methodist Dallas Medical Center, representing the College of American Pathologists  

• Kileen L. Shier, PhD., MBA, D(ABMM), MLS(ASCP)CM, Senior Science Director of Microbiology and Donor Testing at Quest Diagnostics 

• Melanie Sloan, MS, MLS (ASCP) SBB, CQA(ASQ), Senior Director of Accreditation and Quality at AABB 

• Scott Thiel, MBA, MT (ASCP), RAC, Head of Regulatory Affairs at Hologic, Inc. 

• Mario Wijker, MD, PhD, Senior Vice President, Quality, Regulatory, and Clinical Affairs at Bio-Rad Laboratories, Inc. 
• Marisa Winkler, MD, PhD, is an Associate Director for Clinical Trials and the CLIA Laboratory Director at Element Iowa City/JMI Laboratories 

The FDA's Final Rule on Laboratory Developed Tests (LDTs), issued on April 29, 2024, aims to ensure the safety and effectiveness of these tests. The rule clarifies that in vitro diagnostic products (IVDs), including those developed by laboratories, are considered medical devices under the Federal Food, Drug, and Cosmetic Act. Over the next four years, the FDA will phase out its general enforcement discretion approach for LDTs, increasing oversight to ensure these tests meet regulatory standards.

For more information about CLSI and CLSI Final Rule resources, visit LDT Perspective or contact CLSI Director of Marketing Jane Berger at jberger@clsi.org. 

About CLSI 

CLSI is the leading global non-profit laboratory medicine standards development organization, with over 24,000 professional members, 2000 active volunteers, and 250 standards products. CLSI standards are recognized by laboratories, accreditors, and government agencies worldwide as the best way to improve their testing outcomes, maintain accreditation, bring products to market faster, and navigate regulatory hurdles.