Another suit filed against FDA over lab-developed test rule

By Lizzy Lawrence

Aug. 19, 2024

FDA Reporter

A group representing molecular pathologists sued the Food and Drug Administration on Monday over its plan to regulate lab-developed tests. 

It’s the second legal challenge to the rule, following the American Clinical Laboratory Association’s suit in May. The suit, filed in Texas by the Association for Molecular Pathology and University of Texas pathologist Michael Laposata, claims that the FDA overstepped its regulatory bounds when deciding to regulate lab-developed tests. 

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“We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine,” said AMP president Maria Arcila in a statement. 

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   Lizzy Lawrence

   FDA Reporter

   Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter.

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