U.S. FDA approves first rapid coronavirus test; results in 45 minutes

Amid the coronavirus pandemic, the U.S. Food and Drug Administration (FDA) has approved the first rapid COVID-19 coronavirus diagnostic test, with a detection time that only takes about 45 minutes.

rapid coronavirus testSunnyvale, California-based 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, in a statement. “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 nearly 5,000 GeneXpert Systems in the US capable of point-of-care testing and for use in hospitals,” said Cepheid President Warren Kocmond in a statement. “Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today.”

The test will begin shipping next week. For more information about Cepheid’s Xpert Xpress SARS-CoV-2 test, please visit www.cepheid.com/coronavirus.

Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation’s Diagnostics platform.

MacDailyNews Take: This rapid coronavirus test is a major improvement over the current testing regime where results can take days, since samples must be sent to a centralized lab.

4 Comments

  1. Great. Get it out there nationwide, license it to all those foreign users of their equipment and test the hell out of every person on the planet. Then we get somewhere stable enough to control the outbreak.
    Or
    WE CANNOT LET THE CURE BE WORSE THAN THE PROBLEM ITSELF. AT THE END OF THE 15 DAY PERIOD, WE WILL MAKE A DECISION AS TO WHICH WAY WE WANT TO GO!
    — Donald J. Trump (@realDonaldTrump) March 23, 2020

    In a week’s time, release the untested and negative tested individuals from ‘distancing’ obligations so that the economy and Stock Market are not damaged.
    Which flies in the face of the real experts – scientists and medical who say ‘distancing is crucial to avoid millions dying’.
    I do not understand why this is even on the table given the article headline.

    1. Economy/Market was already somewhat broken. The Virus just happened to pop this Bubble; it seemed we were heading this way by years end. it just got accelerated

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