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Federal Regulation of LDTs Subject of Proposed Bill

Two federal lawmakers release draft of a bill that would deal with laboratory-developed tests

THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy and Innovation Act (DAIA) was made […]

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