How advocacy shaped the regulation of laboratory-developed tests

Laboratory-developed tests (LDTs) play a crucial role in personalized patient care by allowing hospitals and medical centers to create specialized tests tailored to their patients’ needs.

In this video, Dr. Anthony Killeen, 2024-2025 President of ADLM and Professor at the University of Minnesota, explains the U.S. FDA’s efforts to regulate LDTs, the concerns raised by the laboratory community, and the successful advocacy that led to a federal court ruling vacating the FDA rule. He also highlights why the existing CLIA regulatory framework remains the preferred approach for overseeing these tests in the U.S.

SelectScience interview filmed at ADLM 2025.