FDA Clears iCubate’s iC-GN Assay for Bloodstream Infection and Subsequent Sepsis


Syndromic test developer iCubate has won FDA clearance for its ic-GN Assay, a qualitative, multiplexed, in vitro diagnostic test designed to detect and identify potentially pathogenic gram negative bacteria associated with bloodstream infection (BSI) and subsequent sepsis.

The iC-GN Assay has been developed to detecs target DNA, and identify gram negative organisms associated with gram negative bacteremia—including Acinetobacter baumannii complex, Escherichia coli and Klebsiella pneumoniae.

The assay is also intended to detect three key gene markers specific to emerging antibiotic resistance, including KPC and NDM, which are associated with resistance to carbapenems.

iC-GN uses iCubate’s core technology, Amplicon-Rescued Multiplex PCR (ARM-PCR), with the aim of detecting multiple pathogens concurrently with high sensitivity and specificity within each assay. Assay results are designed to guide decisions concerning early choice of appropriate antimicrobial therapy.

“With the ability to provide reliable and cost-effective assays for detecting BSI to laboratories of any size, we are confident that iCubate will add value for health care providers to improve patient outcomes,” iCubate CEO Carter Wells said in a statement.

Along with iCubate’s iC-GPC Assay, which won FDA clearance earlier, the newly-cleared assay completes what the company terms a comprehensive BSI detection solution for clinical laboratories in the U.S.

iC-GPC is a qualitative multiplex test for the detection of five of the most common Gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Enterococcus faecalis, and Enterococcus faecium) responsible for bacterial bloodstream infections, performed directly from positive blood cultures.

Additionally, iC-GPC is intended to identify three clinically relevant antibiotic resistance markers specific to methicillin resistant Staphylococcus and vancomycin resistant Enterococcus.

 “The assays are easily performed, load-and-go, affordable tests that require only a minute or two of technologist’s set up time. In addition, the iCubate instrument platform has a small footprint and it’s random access capability of testing up to four positive blood specimens at a time makes it conducive for use by any size laboratory,” stated Paul Granato, PhD, Director of Microbiology, Laboratory Alliance of Central New York.

Laboratory Alliance has used iC-GPC for several years testing over 1,500 positive blood specimens with no instrument failure or breakdown, Granato added.

Granato was the corresponding author of a clinical evaluation of iC-GPC that was published last year in Journal of Clinical Microbiology. The study compared iC-GPC with Luminex’s Verigene Gram-positive blood culture (BC-GP) assay for 1,134 patient blood culture specimens positive for Gram-positive cocci.

The iC-GPC Assay had an overall percent agreement with the BC-GP assay of 95.5%, the study showed.

“The iC-GPC Assay together with the iCubate system is an accurate and reliable tool for the detection of the five most common Gram-positive bacteria and their resistance markers responsible for bloodstream infections,” the clinical evaluation concluded.

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