White Paper

Regulatory Reckoning: Navigating the FDA's Laboratory Developed Tests Regulation

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Regulatory Reckoning: Navigating the FDA's Laboratory Developed Tests Regulation February 2024

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Executive Summary

The FDA's impending LDT rule, slated for finalization in April 2024, ushers in a transformative shift in the regulatory landscape for laboratory-developed tests (LDTs), bringing them under the same stringent oversight as in vitro diagnostics (IVDs). This comprehensive rule, aimed at safeguarding patient safety and ensuring diagnostic excellence, presents a critical juncture for laboratories utilizing LDTs and life science tools and diagnostic companies whose products form the backbone of LDT workflows. To effectively navigate this regulatory transition, life science tools and diagnostic companies must embark on a proactive strategy, encompassing reassessing their product portfolios, enhancing regulatory and clinical development capabilities, adhering to stringent quality standards, and maintaining close engagement with regulatory authorities. By embracing this proactive approach, they can effectively adapt to the FDA's LDT rule, positioning themselves for success in the rapidly evolving diagnostic landscape and eventually emerge as industry leaders in the dynamic clinical diagnostics arena.

Stephane Budel, Ph.D.

Partner, DeciBio

Dr. Stephane Budel, a partner at DeciBio Consulting, brings over 18 years of experience in life science business consulting, entrepreneurship, and academic research. He specializes in commercializing novel technologies in life science research tools and diagnostics, with a particular focus on genomics and next-generation sequencing. Dr. Budel has a track record of addressing diverse business challenges, including product specification strategy and commercial due diligence. He earned his Ph.D. from Yale University, where he researched the molecular mechanisms of schizophrenia.

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Maximilian Schmid, M.D.

Senior Advisor

Dr. Maximilian Schmid, a distinguished healthcare leader and senior advisor, bridges the gap between clinical practice and commercial leadership. Leveraging his comprehensive background in clinical medicine, academic research, and management consulting, he guides diagnostics companies through the full product lifecycle and international business expansion. Renowned for his strategic acumen and innovation in diagnostics, Dr. Schmid holds board certifications in Obstetrics & Gynecology with sub-specialties in Maternal-Fetal Medicine and Clinical Genetics. His academic achievements include a habilitation in Obstetrics & Gynecology and a prior Associate Professorship at the Medical University of Vienna, Austria. A prolific author, Dr. Schmid’s dedication to advancing medical science is evident in his numerous peer-reviewed publications.

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