FDA Authorizes Emergency-Use of Fast-Result COVID-19 Test

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In response to the rapidly spreading of the Coronavirus (COVID-19) the U.S. Food and Drug Administration has issued an emergency-use authorization for the Cepheid Xpert Xpress SARS-CoV-2 test.

“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, which is an incredibly rapid timeline for such an effort. 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,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”

The FDA has been working diligently in order to expedite the review of the test during this public health emergency. The rapid results will assist in the helping the patient to access immediate results, which in-turn will likely slow the spread. Availability of this nasal swab test will be available for point-of-care testing by March 30th.