iCubate® Announces CE IVD Mark for iC-GN Assay™

HUNTSVILLE, AL, June 27, 2019 – iCubate® , a provider of molecular solutions for the rapid diagnosis of infectious diseases, announced the securing of CE IVD Marking for the company’s latest assay, the “iC-GN Assay™”.

The iC-GN Assay is an in vitro diagnostic test for the detection and identification of pathogenic gram negative bacteria and clinically relevant resistance markers associated with bloodstream infections and subsequent sepsis. 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.

The CE IVD Mark confirms that the iC-GN Assay meets the Essential Requirements of the European Directive on In Vitro Diagnostic Medical Devices. With the iC-GN Assay™ and the iC-GPC Assay™ (CE Marked in 2017), iCubate now has a comprehensive solution for the detection of bacteria and important resistant markers associated with bloodstream infections within the European market. The CE Mark allows iCubate to market in over three dozen European countries.

“The staff at iCubate work each day with the goal of providing diagnostic assays to improve patient care,” said Carter Wells, Chief Executive Officer of iCubate. “With both gram positive and gram negative panels now CE Marked, the European market has a new ally in the fight against this unpredictable and deadly condition”.

The Global Sepsis Alliance reports that 3.4 million people each year develop sepsis in the World Health Organization European Region, with 700,000 of those patients not surviving. Bloodstream infections (BSI) and subsequent sepsis are associated with high mortality rates that occur frequently in critically-ill, hospitalized patients.

iCubate’s rapid multiplex assays provide reliable test results for common bacterial causes of bloodstream infections as well as the detection of major antibiotic resistance gene markers directly from a positive blood culture. The user-friendly assays require only 2 to 3 minutes of hands-on time and provide results within a clinically relevant timeline of 3-4.5 hours. With accurate diagnostic information, the clinician can make more informed therapy choices that improve patient outcomes and shorten hospital stays, thereby reducing institutional costs, which favorably impact antimicrobial stewardship programs. 

iCubate’s gram positive assay, the iC-GPC Assay, is U.S. FDA cleared, and the iC-GN Assay is currently under FDA 510(k) review.  Additionally, iCubate is working with global partners to bring these assays to the Asia market.  


About iCubate
Founded by Jian Han, MD, PhD, iCubate® is a molecular diagnostic company providing accurate and affordable syndromic testing to clinical laboratories. Developed by Dr. Han, iCubate’s core technology, Amplicon-Rescued Multiplex PCR (ARM-PCR), detects multiple pathogens concurrently with high sensitivity and specificity within each assay. The portfolio of assays are run on an integrated, intuitive, closed system. The end result is improved turn-around time for pathogenic organism identification and detection of important antimicrobial resistance markers. Offering a scalable, cost-effective platform, iCubate offers accurate testing for labs of any size.

To learn more visit or call 855-256-3330.


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