iCUBATE® PRESENTS DATA ON THE IC-MYCO ASSAY AT THE AMERICAN ASSOCIATION OF CLINICAL CHEMISTRY MEETING
THE iC-MYCO ASSAY WAS RECENTLY DESIGNATED “BREAKTHROUGH DEVICE” BY FDA ANAHEIM, CA, August 8, 2019 – At the 71st Annual American Association of Clinical Chemistry Scientific Meeting and Clinical Lab Expo, iCubate®, a provider of molecular diagnostic solutions for infectious disease detection, presented data on the company’s iC-Myco Assay. iCubate’s latest assay for the detection and identification of potentially pathogenic non-tuberculosis Mycobacterium (NTM) was recently designated as a “Breakthrough Device” by the U.S. Food and Drug Administration. “Faster and more accurate diagnostics are needed by patients with Mycobacterium infections and iCubate has developed a unique assay to meet this need,'' ...
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iCUBATE® EARNS FDA “BREAKTHROUGH DEVICE” DESIGNATION FOR LATEST ASSAY
RAPID IDENTIFICATION OF NON-TUBERCULOSIS MYCOBACTERIUM IS NEEDED FOR THE BENEFIT OF PATIENTS WITH PULMONARY INFECTIONS HUNTSVILLE, AL, August 2, 2019 – iCubate®, provider of accurate and affordable syndromic test systems generating actionable results to healthcare providers, announced today that the company’s iC-Myco Assay™, for the detection and identification of potentially pathogenic non-tuberculosis Mycobacterium (NTM), has been granted designation as a “Breakthrough Device” by the U.S. Food and Drug Administration (FDA). Using iCubate’s proprietary technology and platform, the iC-Myco Assay directly addresses the shortfalls of current NTM diagnostics. In a single assay, the iC-Myco Assay, a qualitative, multiplexed, in vitro diagnostic ...
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Huntsville’s iCubate announces FDA clearance for innovative bloodstream infection testing
YELLOWHAMMER, July 23, 2019 - A Huntsville biotech company announced that it has obtained U.S. Food and Drug Administration (FDA) clearance to provide clinical laboratories with an innovative testing system for bloodstream infections and sepsis. iCubate has obtained clearance for its iC-GN Assay which is a diagnostic test for the detection and identification of potentially pathogenic gram-negative bacteria which are associated with bloodstream infection and subsequent sepsis. According to statistics provided by iCubate, bloodstream infections and subsequent sepsis are associated with high mortality rates that occur frequently in critically-ill, hospitalized patients, with sepsis being the 10th leading cause of death ...
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CEO Corner
HUNTSVILLE, AL, July 22, 2019 – It has been a month of milestones for iCubate with our iC-GN Assay™ receiving CE IVD Marking and US FDA clearance. We look forward to talking about this and what is next for iCubate at the AACC conference in August. iCubate now provides a comprehensive solution for bloodstream infection detection to clinical laboratories of all sizes. With assays designed to detect and identify both gram positive and gram negative organisms associated with bloodstream infection and subsequent sepsis, iCubate is proud to join the fight against this unpredictable and deadly condition. The iCubate assays also ...
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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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