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Thermo Fisher Scientific Authorized For COVID-19 Diagnostic Test

Thermo Fisher Scientific Inc. (TMO) said that on Friday, the U.S. Food and Drug Administration issued an emergency use authorization for its 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. The estimated time-to-result also includes time for sample preparation and instrument analysis.

Thermo Fisher said it currently has 1.5 million tests available to ship under the emergency use authorization or EUA label and expects to quickly ramp up to reach 2 million tests per week.

The company expects to scale production up to 5 million tests per week during the month of April. The available tests will initially be distributed to about 200 labs in the U.S.

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