Recent News

CEO Corner - Thursday, 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 try it for yourself at 1pm on Saturday, June 22nd at booth 4241; and 4) on Sunday, June 23rd @ 1pm at booth 4241, join the discussion about the value iCubate brings to the clinical laboratory. Look forward to seeing you in San Francisco.   Carter Wells CEO, iCubate  

Journal of Biomedical Nanotechnology 2019 Vol 15

Journal of Biomedical Nanotechnology 2019 Vol 15 1598-1608 ...
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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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