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Lab Association Asks Congress To Kill FDA’s Final Rule On LDTs

 
• By Brian Bossetta

In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.

Rule Exception
• Source: Shutterstock

If the Food and Drug Administration’s final rule placing laboratory developed tests (LDTs) under its regulatory purview goes through as planned, almost half of the labs that now make the tests will stop producing them, according to one of the leading laboratory organizations.

In a letter to House and Senate committee chairs, Anthony Killeen, president of the Association for Diagnostics and Laboratory...

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