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iCubate Receives CE Mark for Dx Platform, Bloodstream Infection Assay

NEW YORK (GenomeWeb) – iCubate announced yesterday that it has received CE mark for its first clinical assay, the iC-GPC assay and its platform, the iC-System, used for the rapid diagnosis of pathogenic bacteria associated with bloodstream infection. The CE mark provides an entry for iCubate to begin market integration into the European Union.

The iC-GPC assay leverages iCubate's amplicon rescued multiplex PCR (ARM-PCR) technology, which detects multiple pathogens simultaneously and was developed by company founder and CSO Jian Han. The end result is an improved turnaround time for pathogen identification and detection of antimicrobial resistance markers.  

The iC-GPC assay is a multiplexed, in vitro diagnostic test for the detection and identification of possible pathogenic gram-positive bacteria. The panel identifies bacteria frequently linked to BSI, while providing crucial information specific to resistance markers of interest in patient treatment and management.

"Integrating the iC-System and iC-GPC assay into the European market is a major step toward our overall goal of improved patient treatment through personalized diagnostics," Han said in a statement.

Testing with the iC-GPC assay uses a positive blood culture, with results available in a few hours, rather than with usual microbiological methods that require two to four days to generate results. The system identifies about 90 percent of organisms isolated from a blood culture, while identifying key resistance markers specific to the detection of vancomycin-resistant Enterococcus and methicillin resistant Staphylococcus.

Earlier this month, iCubate's iC-GPC BSI assay received 510(k) clearance from the US Food and Drug Administration.