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. Sossaman
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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
Ms. Swails on Twitter
Dr. Brown on Twitter
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
The Molecular Biomarker Revolution in Metastatic NSCLC
S3Ep3: Regional Medical Laboratory Scientists
Special Episode: Evolving and Emerging Trends in HER2 Classification and Reporting in Breast Cancer
S3Ep2: The Not-So-Trivial History of ASCP
S3Ep1: Current Trends in MLS Education
S2Ep23: Celebrating a Century of ASCP
S2Ep22: Bridging the Gap Between Baby Boomers and Gen Z
S2Ep21: What It's Like to Work Nights
S2Ep20: Leadership Institute Book Club: Glennon Doyle's Untamed
S2Ep19: Creating Robust Patient-Pathologist Consultation Programs
S2Ep18: Evolution of Anatomic and Clinical Pathology in the Last Century
S2Ep17: Anatomy of a Cyberattack
S2Ep16: Lab Week Through the Years
S2Ep15: Life Hacks for Clinical Pathology
S2Ep14: Empowering Women in the Laboratory Workforce
S2Ep13: Promoting DEI in Laboratory Medicine
Special Episode: HER2 Testing in Breast Cancer: Improving IHC Performance
Special Episode: The Science of HER2-low Breast Cancer and Implications for the Pathology Team
Special Episode: Ki67 as a Prognostic and Predictive Biomarker in HR-Positive/HER2-Negative Early Breast Cancer
S2Ep12: Lifehacks for Anatomic Pathology
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