Laboratory Trade Group Sues FDA to Block Testing Regulations

A leading clinical laboratory association and one of its member companies are suing the FDA to overturn a final rule regulating laboratory-developed tests.

The American Clinical Laboratory Association (ACLA) and HealthTrackRx filed a lawsuit against the Food and Drug Administration on Wednesday in the U.S. District Court for the Eastern District of Texas. The association is challenging the agency’s May 6 final rule, which gives the FDA explicit authority to regulate certain medical tests from a single lab, called laboratory-based tests (LDTs).

The lawsuit is the first to block the FDA rule.

ACLA and…