Modernizing Federal Oversight of Laboratory-Developed Tests — Toward Safety, Validity, and Utility

This perspective article examines the growing complexity and widespread use of laboratory-developed tests (LDTs), emphasizing the lack of consistent federal oversight and potential risks to patient safety. It discusses the limitations of existing regulatory frameworks such as CLIA, the consequences of inadequate test validation (as seen with Theranos), and concerns over marketing, misdiagnosis, and inconsistent clinical utility. The authors analyze the failure of the VALID Act and critique ongoing FDA efforts to classify LDTs as medical devices. They advocate for a unified regulatory framework that balances patient safety, transparency, and innovation, while acknowledging the burdens placed on testing laboratories.

This perspective article examines the growing complexity and widespread use of laboratory-developed tests (LDTs), emphasizing the lack of consistent federal oversight and potential risks to patient safety. It discusses the limitations of existing regulatory frameworks such as CLIA, the consequences of inadequate test validation (as seen with Theranos), and concerns over marketing, misdiagnosis, and inconsistent clinical utility. The authors analyze the failure of the VALID Act and critique ongoing FDA efforts to classify LDTs as medical devices. They advocate for a unified regulatory framework that balances patient safety, transparency, and innovation, while acknowledging the burdens placed on testing laboratories.