Time: 9 to 10 a.m.

Location: Low Learning Center

Speaker: Octavia M. Peck Palmer, PhD, FADLM, Vice Chair of Health Equity, Associate Professor, Departments of Pathology, Critical Care Medicine, Clinical and Translational Science; University of Pittsburgh School of Medicine Division Director, Clinical Chemistry; Medical Director, UPMC Presbyterian and Shadyside, Automated Testing Laboratories

Talk Title: Decoding the FDA’s Final Ruling on LDTs: What It Means for Laboratories and Patients

Learning Objectives:

Participants will (be able to):

1. Describe laboratory developed tests (LDTs), how they are used in a clinical setting to guide patient management, and how they are currently defined and regulated.
2. Describe the US Food and Drug Administration (FDA) rule to regulate laboratory-developed tests (LDTs) that was finalized on May 6, 2024.
3. Assess their current LDTs portfolio and develop a plan to align their use with the FDA’s final ruling on LDTs.