iCubate Receives CE Mark for the iC-GPC Assay™ for use on the iC-System™
iCubate’s platform and initial assay now available for European clinical laboratory use
Huntsville, Ala. August 22, 2017 – iCubate, Inc., an innovative molecular diagnostic device company, announced today that it has received CE Mark for its iCubate platform, the iC-System™, and its first clinical assay, the iC-GPC Assay™, used for the rapid detection of pathogenic bacteria associated with bloodstream infection (BSI). The CE Mark paves the way for iCubate to begin market integration into the European Union.
“Obtaining CE Mark for iCubate’s platform and initial assay achieves one of the company’s primary goals and opens the door to market the product in the European Union,” said Carter Wells, Chief Executive Officer of iCubate. “The entire iCubate team is excited about providing a new product to clinical laboratories that produces important diagnostic data for improving patient management.”
iCubate’s core technology, the Amplicon-Rescued Multiplex PCR (ARM-PCR), which detects multiple pathogens concurrently, was developed by company founder and Chief Scientific Officer, Jian Han, M.D., Ph.D. Dr. Han developed ARM-PCR to solve a variety of problems common to clinical laboratories. Using the ARM-PCR technology, along with the understanding that sensitivity and specificity within an assay is paramount, he and the scientific teams at iCubate developed the iC-GPC Assay™. The assay is coupled with an integrated, easy to use, closed system. The end result is improved turn-around for pathogenic organism identification and detection of important antimicrobial resistance markers.
“iCubate is committed to providing this new technology to help laboratory directors, physicians and ultimately patients,” said Dr. Han. “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.”
The iC-GPC Assay™ is a multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria. The panel identifies bacteria commonly associated with BSI, while providing important information specific to resistance markers of prominent interest in patient treatment and management. Testing is performed directly from a positive blood culture with results available in hours rather than with conventional microbiological methods that may require 2-4 days to generate bacterial identification and antimicrobial susceptibility test results. The system identifies approximately 90 percent of organisms isolated from a blood culture, while identifying key resistance markers specific to the identification of methicillin resistant Staphylococcus and vancomycin resistant Enterococcus.
According to recent studies, BSIs and subsequent sepsis occurs in the U.S. at an approximate rate of 300 cases per 100,000 people per year. Sepsis and the ensuing complications are now the 10th leading cause of death in the U.S. with case numbers rising annually.
The iC-GPC Assay™ is the first of the company’s portfolio to earn the CE Mark. CE Mark confirms that the product meets the Essential Requirements of the European Directive on In Vitro Diagnostic Medical Devices.
Earlier this month, iCubate earned FDA 510(k) clearance for the iC-System™ and iC-GPC Assay™ for use in clinical laboratories in the United States.
iCubate®, Incorporated is a privately-held molecular diagnostic company. iCubate’s mission is to provide a personal diagnosis having an immediate and intelligent impact on patient lives. The integrated iCubate System (iC-System™) enables extraction, multiplexed amplification and detection automatically in a closed and disposable cassette. iCubate® provides a sample in-answer out diagnostic test with highly multiplexing ARM-PCR technology and a user friendly, flexible platform. Currently, iCubate® products are available world-wide for non-clinical, research-use only in the areas of health, agriculture, food safety and defense. See icubate.com for more information.
Some statements in this press release may be “forward-looking statements”. iCubate® cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. iCubate undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.