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Thermo Fisher Scientific SARS-CoV-2 Test Gets Expanded FDA Emergency Use Authorization

NEW YORK – Thermo Fisher Scientific said on Tuesday that the US Food and Drug Administration has further expanded emergency use authorization for its real-time PCR test for SARS-CoV-2.

The test, called Applied Biosystems TaqPath COVID-19 Combo Kit, initially received EUA on March 13, which was expanded on March 24 and April 20.

The new expansion increases the number of PCR instruments and types of reagents and consumables labs can use to run the test. Labs can now run the test on specific configurations of the QuantStudio 7 Flex and QuantStudio 5 real-time PCR instruments, which significantly increases the number of instruments available for testing.

In addition, labs can now use the firm's MagMax viral/pathogen II nucleic isolation kit, as well as additional types of microplates.