Tests that are designed in-house to fulfill a clinical need (but aren’t FDA approved) qualify as laboratory developed tests. And these LDTs are currently regulated by CLIA. But the FDA is proposing a new rule that would give them oversight of the design and development of laboratory developed tests. So, what does that mean for us? How would this new legislation impact everyday practice inside the lab? 

On this episode of the podcast, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP, are joined by Dr. Gregory Sossaman, MD, Clinical Pathologist and Service Line Lead for Pathology and Lab Medicine at Ochsner Health, Dr. Jonathan Genzen, MD, Clinical Pathology Professor at the University of Utah and Chief Medical Officer and Senior Director of Government Affairs at ARUP Laboratories, and Mr. Matthew Schulze, Senior Director for the Center for Public Policy at ASCP, to discuss the implications of the proposed FDA regulations for LDTs. 

Our panelists share their anxiety around the labor and costs involved in complying with the new rule and describe how lab professionals might be forced into situations where we deny care due to regulations. Listen in to understand why public opinion favors the proposed rule and learn how to share your concerns with the FDA during the public comment period from October 3rd to December 4th, 2023. 

Topics Covered  

· How tests that are not FDA approved but designed in-house to fulfill a clinical need fall into the category of laboratory developed tests
· Examples of common LDTs used in academic medical centers + large community health systems
· The current regulations re: performance standards for LDTs under CLIA
· Dr. Sossaman, Dr. Genzen & Mr. Schulze’s concerns around the labor and costs involved in complying with the proposed FDA rule
· The lack of clarity re: what modifications to FDA approved tests would be allowed under the proposed regulations
· How direct-to-consumer testing, the pandemic and technological advances influenced the proposed FDA rule and why the general public is in favor of it
· How the proposed FDA regulations would affect our ability to respond in future pandemics

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Connect with Dr. Genzen
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Connect with Mr. Schulze
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Connect with Ms. Swails & Dr. Brown
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Resources
ASCP Membership 2024
Proposed FDA Regulation of Laboratory Developed Tests
Public Comment on the FDA’s Proposed Rule
Inside the Lab in the ASCP Store