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LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 
• By Brian Bossetta

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

(Shutterstock)

Judge Sean Jordan of the US District Court for the Eastern District of Texas on Monday delivered a huge victory to clinical labs by granting summary judgment to the Association for Molecular Pathology (AMP), which had sued the Food and Drug Administration to stop it from assuming regulatory oversight of laboratory-developed tests, or LDTs.

The American Clinical Laboratory Association (ACLA) was a co-plaintiff in the suit and said the ruling accepts many of the association’s primary arguments, chief among them that the FDA simply...

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