- In March 2025, a U.S. District Court (Eastern District of Texas) vacated the FDA’s final rule that would have classified most LDTs as medical devices—and notably, the agency declined to appeal this decision—meaning LDTs remain regulated under CLIA rather than by the FDA. This judgment provides legal clarity and regulatory relief for clinical labs relying on LDTs
- In May 2024, the FDA issued a final rule to gradually phase in oversight of certain LDTs as in vitro diagnostic (IVD) devices—marking a shift toward increasing regulatory scrutiny, with compliance deadlines beginning from May 6, 2025
- In March 2025, ARUP Laboratories publicly welcomed the court’s decision to vacate FDA oversight, emphasizing that LDTs play a "vital role in delivering the best patient care"—especially for rare diseases and personalized diagnostics
- In June 2025, Johns Hopkins researchers demonstrated a multicancer early detection (MCED) LDT via ultrasensitive cell-free DNA sequencing that detected cancers up to three years before symptoms appeared—highlighting the potential of LDTs in proactive diagnostics
