Newsletter 3/27/20: iCubate to Join the Fight Against COVID-19
iCubate to join the fight against COVID-19 iCubate plans to soon offer a diagnostic test for COVID-19. iCubate's COVID-19 assay will run on the company's FDA-cleared, fully automated, random access system for the rapid detection of infectious pathogens. iCubate has contacted FDA to initiate the Emergency Use Authorization process. Due to recent changes in the FDA’s EUA process, however, iCubate plans to soon provide the COVID-19 Assay to areas where on-site testing may be the best option for improved patient care. The system can be placed in laboratories, hospitals and at temporary collection sites, testing stations and other point of ...
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COVID-19 FAQ
When person-to-person spread has occurred with other coronavirus types such as MERS and SARS, it is thought to have happened mainly via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory pathogens spread. Spread of SARS and MERS between people has generally occurred between close contacts. What are the symptoms? Patients with COVID-19 have had mild to severe respiratory illness with symptoms including: Fever Cough Shortness of breath What is the incubation period? The CDC believes at this time that symptoms of COVID-19 may appear in as few as two days or ...
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INTERNATIONAL BUSINESS BASED IN HUNTSVILLE HELPING WITH CORONAVIRUS ILLNESS
WAAY, January 31, 2020 - In Huntsville, the new, dangerous strain of the coronavirus isn't an issue right now. But we found out how one Rocket City company is helping fight the outbreak. A company called iCubate designed a machine that can take a strain of a respiratory issue and single out the strain of the specific virus and possible symptoms. The CEO told WAAY-31 they last used it during the swine flu outbreak and with time, it could be used again to help fight coronavirus. This machine is somewhat of a tape recorder.... You take the virus' strain and ...
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HUDSONALPHA SCIENTISTS WORKING ON TECHNOLOGY TO DIAGNOSE AND COMBAT CORONAVIRUS
WAFF, January 31, 2020 - The Wuhan coronavirus is a global disease triggering a global response, and researchers at the HudsonAlpha Institute for Biotechnology are pulling their weight. Sister companies iCubate and iRepertoire (under the HudsonAlpha umbrella) are developing and distributing technology which diagnoses and treats the illness. iCubate has developed a program that allows human DNA to be tested for dozens of diseases at a time. DNA is put in a “cassette” then plugged into a large cube-shaped scanner, which feeds results into the computer. It will allow doctors to more quickly identify what’s wrong with the patient and ...
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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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