Molecular Pathology Trade Group Sues FDA Over Lab Test Authority

A group representing molecular pathologists is suing to block the FDA’s authority to regulate laboratory-developed tests.

The Food and Drug Administration’s final rule giving it explicit power to oversee certain medical tests that come from a single laboratory, known as lab-developed tests (LDTs), “represents the height of arbitrary, capricious, and abusive agency action,” the Association for Molecular Pathology and pathologist Michael Laposata wrote in a Monday complaint before the US District Court for the Southern District of Texas.

The lawsuit fuels the debate on whether the agency should have LDT oversight, which the final rule now makes clear that in ...