Gram-Positive & Gram-Negative, FDA Cleared

Gram-Positive Cocci

The iCubate iC-GPC Assay™ is a multiplexed, in vitro diagnostic test for the rapid detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI).  Traditional culture techniques may require 2-4 days to identify both the causative organism and resistance profile, resulting in delayed treatment and increased costs.  The iC-GPC Assay™ provides bacterial identification and resistance determination from positive blood cultures up to 48 hours faster than conventional methods, improving time to treatment and patient outcomes. The iC-GPC Assay™ detects five of the most common gram positive organisms associated with BSI as well as three clinically significant resistance markers:

Bacterial Species Resistance Markers
Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Enterococcus faecalis

Enterococcus faecium

mecA– associated with methicillin resistance

vanA- associated with vancomycin resistance

vanB– associated with vancomycin resistance

FDA Cleared

Gram-Negative Rods

The iCubate iC-GN Assay™ is a multiplexed, in vitro diagnostic test for the rapid detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI).  Traditional culture techniques may require 2-4 days to identify both the causative organism and resistance profile, resulting in delayed treatment and increased costs.  The iC-GN Assay™ provides bacterial identification and resistance determination from positive blood cultures up to 48 hours faster than conventional methods, improving time to treatment and patient outcomes. The iC-GN Assay™ detects eight of the most common gram negative organisms associated with BSI as well as three clinically significant resistance markers

Bacterial Genera and Species Resistance Markers
Acinetobacter baumannii complex

Enterobacter cloacae complex

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

Pseudomonas aeruginosa

Proteus species

Serratia marcescens

KPC- carbapenemase

NDM- carbapenemase

CTX-M group 1- extended spectrum β-lactamase

FDA Cleared

The iCubate® system is the cost-effective molecular diagnostic solution providing clinical microbiology labs rapid syndromic testing for infectious diseases, leading to better care sooner.

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