FDA Declines to Appeal LDT Court Ruling

The Food and Drug Administration declined to appeal a recent district court ruling that overturned the agency’s final rule regulating laboratory-developed tests (LDTs). The 60-day window to file an appeal expired this weekend, effectively ending the agency’s effort to expand its regulatory authority over LDTs.

In a March 31 ruling, the U.S. District Court for the Eastern District of Texas determined that the final rule issued by FDA in April 2024, which established a regulatory framework for LDTs, exceeded the FDA’s authority and was, therefore, unlawful. The ruling was in response to consolidated lawsuits filed by the American Clinical Laboratory Association (ACLA) and by the Association for Molecular Pathology (AMP). 

AABB has long supported an alternative approach to regulating LDTs. In previous public statements, AABB noted that LDTs play a critical role in diagnosing and treating conditions such as cancer, rare diseases and infections – and that regulations set forth in the final rule could jeopardize this. AABB also cautioned that the final rule could lead to financial burdens on laboratories, stifle innovation and compromise patient care.

“FDA’s decision not to appeal the district court’s ruling is a victory for both medical laboratories and the patients who depend on them,” said AABB President Meghan Delaney, DO, MPH.