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FDA Issues EUA to Thermo Fisher

For diagnostic test used to detect COVID-19

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s diagnostic test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and not for any other viruses or pathogens.   The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. Th...

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