FDA grants 'emergency use' coronavirus test that can deliver results in 45 minutes

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FDA grants 'emergency use' coronavirus test that can deliver results in 45 minutes
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Cepheid has received emergency authorization from the Food and Drug Administration to use its rapid molecular test for point-of-care patients that can detect coronavirus in 45 minutes. This is the first coronavirus that can be conducted entirely at the point of care for patients and deliver results in less than an hour. Tests are typically sent to central reference labs that can take several days to deliver results.

Medical take a patient's coronavirus test during a trial run for a new FEMA drive-thru coronavirus testing clinic at CVS at 720 Boston Turnpike in Shrewsbury, MA on March 19, 2020.Cepheid has received emergency authorization from the Food and Drug Administration to use its rapid molecular test for point-of-care patients that can detect coronavirus in 45 minutes.

This is the first coronavirus that can be conducted entirely at the point of care for patients and deliver results in less than an hour.Diagnostics company Cepheid on Saturday said it has received emergency authorization from the U.S. Food and Drug Administration to use its rapid molecular test for point-of-care patients that can detect the virus that causes COVID-19 in 45 minutes.

This is the first coronavirus test that can be conducted entirely at the point-of-care for patients and deliver results in less than an hour. Typically, tests are sent to central reference labs that can takeThe test, called SAR-CoV-2 Xpert Xpress, was developed by Cepheid, a Sunnyvale, California, company was designed to detect SARS-CoV-2, the virus that is causing COVID-19.

Cepheid uses a testing machine called GeneXpert that can run a full test in 45 minutes. There are currently more than 23,000 automated GeneXpert systems worldwide, with nearly 5,000 of them in the U.S., Cepheid said in a statement."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.

Cepheid President Warren Kocmond added that its automated systems "do not require users to have specialty training" to perform the tests.

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