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Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test


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SILVER SPRING, Md., March 5, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. 
The authorization of this new diagnostic test underscores FDA s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans, said Acting FDA Commissioner Janet Woodcock, M.D. The FDA will continue to expand Americans access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States. ....

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