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Utah company develops first fully FDA-authorized COVID-19 test
A BYU life science student works with COVID-19 samples. A Utah lab called BioFire developed the first fully FDA-approved COVID-19 test. (Todd Jackson)
A biotech company from Utah has developed the first COVID-19 test to be fully authorized for use by the U.S. Food and Drug Administration.
The test, known as the BioFire Respiratory Panel 2.1, was granted full marketing authorization by the FDA on March 17. Other COVID-19 tests are being used under the FDA’s Emergency Use Authorization which will ultimately be lifted as the country nears the end of the pandemic.