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At FDA, Laboratory-Developed Tests Are in the Crosshairs

ACLA prepared to fight FDA’s LDT guidance

This article is an excerpt from a 600-word article in the March 21 issue of THE DARK REPORT. Full details of FDA’s laboratory-developed test guidance and recent actions against labs that are marketing LDTs are included in the original article, available to paid members. The Food and Drug Administration claims that clinical laboratories are marketing their (LDTs) laboratory-developed tests – which make …

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