July 18, 2019—The U.S. Food and Drug Administration has cleared iCubate’s iC-GN Assay, a qualitative, multiplexed, in vitro diagnostic test. The assay identifies eight Gram-negative organisms associated with bloodstream infection and subsequent sepsis, 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.
“The rapid identification of the clinically relevant bacteria responsible for septicemia and the detection of their gene resistance determinants will have a favorable impact on patient outcomes, antibiotic stewardship programs, and hospital costs. The assays are easily performed, load-and-go, affordable tests that require only a minute or two of technologists’ setup time,” Paul Granato, PhD, director of microbiology, Laboratory Alliance of Central New York, said in a press release from iCubate. “In addition, the iCubate instrument platform has a small footprint, and its random access capability of testing up to four positive blood specimens at a time makes it conducive for use by any size laboratory.”