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iCubate Bloodstream Infection Assay Cleared by FDA

NEW YORK – iCubate said late on Friday that the US Food and Drug Administration cleared the company's assay for detecting and identifying potentially pathogenic gram-negative bacteria associated with bloodstream infection and subsequent sepsis. 

The iC-GN Assay uses multiplex PCR to detect target DNA and identify gram-negative organisms associated with gram-negative bacteremia such as Acinetobacter baumannii complex, Escherichia coli, and Klebsiella pneumonia. It also identifies three antibiotic-resistance markers, including KPC and NDM, which have been associated with carbapenem resistance.  

The test was CE marked in late June.

According to Huntsville, Alabama-based iCubate, this most recent clearance along with the previously cleared iC-GPC Assay completes the firm's comprehensive bloodstream infection detection solution for US clinical labs. 

"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.