Skip to main content
Premium Trial:

Request an Annual Quote

iCubate Receives CE IVD Mark for Bloodstream Infection Assay

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.



The Scan

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.

Duke University Team Develops Programmable RNA Tool for Cell Editing

Researchers have developed an RNA-based editing tool that can target specific cells, as they describe in Nature.

Novel Gene Editing Approach for Treating Cystic Fibrosis

Researchers in Science Advances report on their development of a non-nuclease-based gene editing approach they hope to apply to treat cystic fibrosis.

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.