NEW YORK – iCubate said today that it has secured CE IVD Marking for its iC-GN Assay for the detection and identification of pathogenic gram-negative bacteria and clinically relevant resistance markers associated with bloodstream infections and subsequent sepsis.
The firm said that the CE mark allows it to market its assays in more than three dozen European countries.
Identification occurs directly from a positive blood culture specimen in less than 4 hours, decreasing the time to appropriate antimicrobial therapy and improving patient outcomes, iCubate said. Its core technology, amplicon-rescued multiplex PCR (ARM-PCR), enables detection of multiple pathogens concurrently within each assay, the firm said.
Its iC-GN Assay and gram positive iC-GPC Assay, CE marked in 2017, gives iCubate "a comprehensive solution" within the European market for the detection of bacteria and important resistance markers associated with bloodstream infections, the firm said in a statement.
The iC-GPC Assay has received clearance from the US Food and Drug Administration, and the iC-GN Assay is currently under FDA 510(k) review.
The Huntsville, Alabama-based firm said that it is working with global partners to bring its assays to the Asian market. In April, the company announced that it has formed a joint venture with Wondfo Biotech to commercialize infectious disease molecular diagnostics in China.