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.
The companion iC-GPC Assay provides identification of five common Gram-positive organisms associated with Gram-positive bacteremia, including Staphylococcus aureus. The assay also identifies three clinically relevant antibiotic resistance markers specific to methicillin-resistant Staphylococcus and vancomycin-resistant Enterococcus.
iCubate, 855-256-3330