A podcast that explores the future of laboratory medicine
Join Dr. Brian Jackson, adjunct professor of pathology at the University of Utah and a medical director at ARUP Laboratories, as he interviews some of the top minds in diagnostic laboratory medicine. Listeners are privy to personal anecdotes and creative insights into important challenges facing laboratories and clinicians.
An Interview With Dr. Jonathan Genzen: Answering Your Questions About the FDA’s Final Rule on LDTs
As of September 2024, there remains enormous uncertainty about the FDA’s final rule on laboratory-developed tests (LDTs). Will it hold up in court? Which tests are subject to which requirements? How can laboratories best prepare? In this interview, Dr. Jonathan Genzen, ARUP’s chief medical officer and senior director of governmental affairs, responds to questions sent in by members of the laboratory community.
Related Information:
ARUP Resources on the FDA’s Final Rule on Laboratory-Developed Tests
ARUP Webinar—The FDA’s Final Rule on LDTs: What You Need To Know
ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests
Email the FDA with questions on the final rule
Originally published September 11, 2024
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