The Impact of the New FDA Final Rule on Laboratory Developed Tests (LDT) in Transplantation
The Impact of the New FDA Final Rule on Laboratory Developed Tests (LDT) in Transplantation
Learn more about a recent FDA rule revision and the potential effect it may have on the development of new diagnostic assays, particularly affecting molecular diagnostics and testing in transplantation.
- 3:00 PM - 4:00 PM EDT
- Virtual
Why is this topic important?
A recent FDA rule revision has eliminated the FDA approval exemption for new lab developed tests (LDTs). Existing LDTs are grandfathered in but will also be subject to FDA regulation under some circumstances. This may have an effect on the development of new diagnostic assays, particularly affecting molecular diagnostics and esoteric and routine testing in transplantation and other fields of medicine.
April 2025 Update: On March 31, 2025, the Eastern District of Texas vacated the FDA’s Final Rule that was intended to regulate LDTs as medical devices similar to in vitro diagnostic (IVD) tests, which are commercially manufactured and undergo pre-market review by FDA. At the time of this update, it is still possible that the FDA could appeal the decision to halt plans for laboratories to comply with the Final Rule and the deadline to implement certain features of FDA’s medical device quality system regulations by May 6, 2025. It is still to be determined whether the FDA will seek to appeal the decision, however.
Speaker:
- Annette Jackson, PhD • Associate Professor, Departments of Surgery & Immunology, Duke University School of Medicine, Durham, NC
Moderator:
- Loren Gragert, PhD • Assistant Professor, Tulane University School of Medicine, New Orleans, LA
Discussant:
- Donald Karcher, MD, FCAP • Professor and Immediate Past Chair of Pathology, George Washington University Medical Center, Washington, DC
Additional Content Contributed by:
- Sarah Turbett, MD • Instructor of Medicine, Harvard Medical School, Boston, MA
The AST Education Committee would like to thank the AST Transplant Diagnostics Community of Practice (TxDx COP) for suggesting this topic as part of the 2024-2025 T3 webinar series. Learn more about AST's COPs at www.myast.org/cops.
Timely Topics in Transplantation (T3) webinars are $25.00 but free for AST members! To learn more about upcoming T3 webinars and view past T3 archives, visit the T3 webinar series page on the myAST website.
There is no continuing education credit available for this webinar.
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