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

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 Medicine (ADLM), says recent surveys the association conducted found the...