iCUBATE® EARNS FDA CLEARANCE FOR LATEST ASSAY
NOW PROVIDING U.S. CLINICAL LABORATORIES A COMPREHENSIVE DETECTION SOLUTION IN THE BATTLE AGAINST BLOODSTREAM INFECTIONS AND SUBSEQUENT SEPSIS HUNTSVILLE, AL, July 12, 2019 – iCubate®, provider of accurate and affordable syndromic test systems generating actionable results to healthcare providers, announced today that it has obtained U.S. Food and Drug Administration (FDA) clearance for the iC-GN Assay™. The iC-GN Assay is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria which are associated with bloodstream infection (BSI) and subsequent sepsis. Additionally, the iC-GN Assay detects important gene markers, specific to emerging antibiotic ...
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iCubate Receives CE IVD Mark for Bloodstream Infection Assay
NEW YORK (360Dx), June 28, 2019 – 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 ...
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iCubate Receives CE IVD Mark for Bloodstream Infection Assay
NEW YORK, (GenomeWeb), Jun 28, 2019, staff reporter – 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 ...
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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 ...
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CEO Corner – ASM Microbe 2019
SAN FRANCISCO, CA, June 26, 2019 - It was our privilege to be a part of ASM Microbe this year! We enjoyed seeing colleagues, meeting new friends, networking and learning more about the leading edge work in the ASM community. From the feedback I received, many of you were also very pleased with ASM Microbe 2019! To those who attended our workshop, a “Clinical Perspective of the iCubate Solution for Bloodstream Infection”, thank you for making the time to be with us. The questions were thoughtful and the comments were encouraging. If you were not able to attend, please contact ...
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CEO Corner
SAN FRANCISCO, CA, June 13, 2019 - iCubate is proud to be a part of ASM Microbe 2019. Many of us will be on site at the Moscone Center in San Francisco for this outstanding scientific conference. At ASM Microbe 2019, there are many ways to learn why iCubate is right for your lab. These include: 1) attend iCubate's workshop @ 1pm on Thursday, June 20th; 2) stop by booth 4241 at 1pm on Friday, June 21st to see how easy it is to use iCubate assays; 3) Wes Coleman will demonstrate operating the iCubate platform - or you can ...
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iCubate, Wondfo Biotech Form Chinese JV to Develop MDx Assays
NEW YORK (GenomeWeb) — iCubate said today that it has formed a joint venture with Wondfo Biotech to commercialize infectious disease molecular diagnostics in China. The joint venture — called Wondfo-iCubate Biotech — will develop assays using iCubate's amplicon-rescued multiplex PCR (arm-PCR) technology, which the company has said can amplify up to a quarter of a million unique targets in one reaction with high specificity and sensitivity. iCubate said that it signed a series of strategic cooperation agreements with Guangzhou-based Wondfo in late 2018 to set the stage for the establishment of Wondfo-iCubate Biotech, and that the joint venture has ...
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iCubate® receives the 2019 NAITA Global Trade Award
HUNTSVILLE, AL, April 19, 2019 – The North Alabama International Trade Association announced Thursday that Huntsville molecular diagnostic firm iCubate® received the 2019 NAITA Global Trade Award at NAITA’s 36th Annual World Trade Day Luncheon. With international sales leading the way to increased market opportunities, iCubate® provides rapid, accurate and affordable syndromic testing for infectious diseases to clinical laboratories of all sizes, ensuring that care providers across the globe have the right tools to improve treatment and outcomes for their patients. iCubate®, an associate company at HudsonAlpha Institute for Biotechnology, was founded in 2009 by Jian Han, MD, PhD, who ...
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