FDA approves new coronavirus test that can have ‘results within hours’ instead of days
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The Food and Drug Administration (FDA) issued emergency authorization Saturday for a novel coronavirus (COVID-19) test kit made by Cepheid Inc. that can yield results in a matter of hours instead of days.
The new tool is called the «Cepheid Xpert Xpress SARS-CoV-2 test» and will be made available to the public by the end of the month.
«The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30,» the FDA said in a press release.
Health and Human Services (HHS) Secretary Alex Azar added: «With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them.»
Cepheid, which is based out of Sunnyvale, Calif., provided Fox News with footage of the test kit that they claim can bounce back positive or negative results, in as little as 45 minutes.
See the test in action here:
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The doctor or clinician collects the patient’s biological sample with a swab. That sample is then mixed in a tube and transferred with an included pipette into the Cepheid cartridge, which contains testing reagents, according to the company.
The cartridge is closed and placed into what is called a «GeneXpert machine,» which determines if the patient has been infected or not.
There are more than 23,000 automated GeneXpert systems across the globe, and almost 5,000 of them are in the U.S., Cepheid said 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,» Cepheid President Warren Kocmond explained.
Cepheid expects to begin shipping out the test later next week.
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«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,» said Dr. David Persing, MD, Ph.D., who is the 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,» he added.
As of late Friday, there were nearly 20,000 confirmed cases of coronavirus in the U.S. and more than 246 confirmed deaths.
