Bacterial Test Well-Suited for Small, Medium Labs, Study Says
June 29, 2018 - NEW YORK (GenomeWeb) – Researchers from four clinical microbiology laboratories reported this month that the iC-GPC assay developed by Huntsville, Alabama-based iCubate is an accurate and reliable tool for the detection of the five most common gram-positive bacteria responsible for bloodstream infections. Additionally, the test detects the presence of the three clinically relevant antibiotic resistance markers specific to methicillin-resistant Staphylococcus and vancomycin-resistant Enterococcus, they noted. The firm's assay and system may be particularly suitable for use in small and medium laboratories that don't have the sophisticated technical staff or time to devote to run more technical and more expensive assays, ...
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Following First FDA Approval for MDx Platform, iCubate Has Eye on Point-of-Care Market
August 30, 2017 - NEW YORK (GenomeWeb) – Having recently secured US Food and Drug Administration approval for its molecular testing platform and first test, the iC-GPC assay for gram-positive bacteria associated with bloodstream infections and antibiotic resistance markers, iCubate is already planning its next commercial assay. The Huntsville, Alabama-based spinout of the HudsonAlpha Institute of Biotechnology plans to tailor its next bloodstream infection product to a gram-negative bacteria detection and drug resistant genes, and believes this assay will be even more extensive than the gram-positive assay. Company founder and CSO Jian Han envisions a future where point-of-care testing using their upcoming devices ...
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CAD Lays the Groundwork for iCubate’s DNA Testing Devices
September 24, 2018 - iCubate, according to the company’s website, is a molecular diagnostic company with a novel multiplex polymerase chain reaction (mPCR) technology. It is also an integrated platform for infectious disease diagnostics and research applications. The iC-Cassette. (Image courtesy of iCubate.) To shed light on what this all means, and to explain how the company designed this system, we spoke to James Bullington, chief technology officer (CTO) of LSINC to learn all about it. LSINC is a product development, engineering design and consultancy firm, which has been helping to design and produce iCubate’s products since 2008. After completing ...
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“Providing Molecular Diagnostic Solutions One Cassette at a Time”
Huntsville, Ala. March 7, 2018 – iCubate®, Inc., an innovative molecular diagnostic device company, announced today that it will host a workshop presentation at the South Central Association of Clinical Microbiology meeting in French Lick, Indiana. The presentation, “Providing Molecular Diagnostic Solutions One Cassette at a Time,” will be on Thursday, March 8 at 10 am at the French Lick Resort, 8670 West State Street. Among the items discussed will be the importance of timely, accurate results when detecting bloodstream infection, clinical laboratory requirements and iCubate’s recently cleared iC-GPC Assay™. The iC-GPC Assay is used for the rapid detection of ...
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iCubate® to present FDA cleared pathogenic bacteria detection system at AMP Meeting
Huntsville, Ala. November 13, 2017 – iCubate®, Inc., an innovative molecular diagnostic device company, announced today that it will host a workshop presentation at the Association of Molecular Pathology (AMP) meeting in Salt Lake City, Utah. The presentation will be on Wednesday, November 15 at 4 pm at the Calvin L. Rampton Salt Palace Convention Center. The presentation, titled “Clinical Application of the iCubate Gram-Positive Cocci (iC-GPC) Assay,” will feature key opinion leaders and iCubate leadership. The iC-GPC Assay™, used for the rapid detection of pathogenic bacteria associated with bloodstream infections, earned U.S. FDA clearance earlier this year. Among those participating in the workshop presentation ...
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iCubate Receives CE Mark for the iC-GPC Assay™
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 ...
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iCubate® Earns FDA Clearance
iCubate® Earns FDA Clearance for A Unique Diagnostic Solution for the diagnosis of Bloodstream Infections iCubate’s “ARMPCR” technology, integrated platform and initial assay now available for United States Clinical Laboratories Huntsville, Ala. August 10, 2017 – iCubate®, Inc., an innovative molecular diagnostic device company, announced today that it has earned U.S. Food and Drug Administration (FDA) clearance 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 FDA clearance allows iCubate to market, sell and distribute the cleared products to U.S. Clinical ...
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iCubate® forms Scientific Advisory Board
Huntsville, Ala. — October 6, 2016 —iCubate®, a molecular diagnostic company, has formed a Scientific Advisory Board to advance the company’s goal of developing and marketing technologies and products for personalized diagnostics. The advisory board will work with iCubate’s board and management team to ensure the company continues to develop innovative products that meet market demand and are positioned for long-term growth and success. “iCubate is privileged to have these individuals as part of our Scientific Advisory Board. The advice and guidance offered by this group of distinguished scientists will be of tremendous value as we position the company’s future ...
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