Close Menu
    Facebook X (Twitter) Instagram
    Facebook Instagram Threads
    Global BiodefenseGlobal Biodefense
    Subscribe
    • Featured News
    • Funding
    • Directory
    • Jobs
    • Events
    Global BiodefenseGlobal Biodefense
    Biodetection

    Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

    By Global Biodefense StaffMarch 21, 2020
    Share
    Facebook LinkedIn Reddit Email

    First Rapid, Point-of-Care and Near-Patient Molecular Test for Detection of Virus that Causes COVID-19

    Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes.

    “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”

    Cepheid currently has an install base of nearly 5,000 GeneXpert® Systems in the US capable of point-of-care testing and for use in hospitals.

    COVID-19 Editor Pick Magazine Edition 24 March 2020 POC Diagnostics Public Health Emergency Rapid Diagnostics SARS-CoV-2
    Share. Facebook LinkedIn Reddit Email
    Previous ArticleVentec Life Systems and GM Collaborate on Ventilator Production Surge
    Next Article Gavi Board Calls for Bold Engagement to Respond to COVID-19

    Related Stories

    First Light Diagnostics Receives FDA Clearance for Rapid Anthrax Test

    December 5, 2023

    Chlorine Exposure Biomarkers in a Large Animal Model

    December 5, 2023

    ARPA-H Announces New Tiered Proposal Submission System to Reduce Applicant Barriers

    December 5, 2023

    Needle-Free Vaccine Patch Against Zika Virus

    December 2, 2023
    News Scan

    Biodefense Headlines – 30 November 2023

    News Scan November 30, 2023

    News highlights on health security threats and countermeasures curated by Global Biodefense This week’s selections include the largest ever outbreak of mpox in the DRC; launch of National Wastewater Surveillance Program dashboard; low uptake of COVID-19 boosters and flu vaccines;…

    Upcoming Events

    Mar 12
    Hybrid Hybrid Event
    March 12, 2024 - March 17, 2024

    2024 Fungal Genetics Conference

    Mar 21
    March 21, 2024 - March 23, 2024

    ASPPH 2024 Annual Meeting

    View Calendar

    Subscribe to Global Biodefense

    Get the latest news on pathogens and preparedness

    News on pathogens and preparedness for public health emergencies

    © 2023 Stemar Media Group LLC
    • About
    • Contact
    • Privacy
    • Subscribe

    Type above and press Enter to search. Press Esc to cancel.