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FDA clears iCubate iC-GN Assay

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November 2019—The FDA has cleared iCubate’s iC-GN Assay for the detection and identification of Gram-negative bacteria that are associated with bloodstream infection and subsequent sepsis.

The qualitative, multiplexed, in vitro diagnostic test identifies eight Gram-negative organisms associated with bloodstream infection, including Acinetobacter baumannii complex, Escherichia coli, and Klebsiella pneumoniae, as well as three resistance markers, including Klebsiella pneumoniae carbapenemase and New Delhi metallo-β-lactamase carbapenemase.

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