Laboratory Trade Group Sues FDA to Block Regulation of Tests (1)

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

The American Clinical Laboratory Association (ACLA) and HealthTrackRx Inc. on Wednesday filed a lawsuit against the Food and Drug Administration in the US District Court for the Eastern District of Texas. The challenge is the first to seek to block the agency’s May 6 final rule that gives the FDA explicit authority to regulate certain medical tests that come from a single laboratory, known as lab-developed tests (LDTs).

The ACLA and HealthTrackRx said in a statement ...