FDA clears Aperio AT2 DX for clinical diagnosis

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June 11, 2019–Leica Biosystems received clearance from the Food and Drug Administration to market its Aperio AT2 DX System for clinical diagnosis in the United States.

A multicenter study supporting this clearance was conducted at five clinical study sites: University of California Davis, Pacific Rim Pathology, Dignity Health, TriCore Reference Laboratories, and Intermountain Healthcare. The participating pathologists read approximately 16,000 cases.