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Emergency use authorization for Thermo Fisher Scientific’s COVID-19 diagnostic test expanded by US FDA

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The US FDA has expanded the emergency use authorization (EUA) granted to Thermo Fisher Scientific’s (MA, USA) COVID-19 diagnostic test. The expansion is intended to facilitate workflow flexibility and increase throughput by allowing more labs to perform COVID-19 diagnostic tests.

Thermo Fisher Scientific’s Applied Biosystems TaqPath assay combined with real-time PCR technology is capable of qualitatively detecting nucleic acid from SARS-CoV-2, the virus responsible for the global COVID-19 pandemic.

The diagnostic test was originally granted EUA by the US FDA on March 13, 2020 and subsequently received the CE mark for use in the European Union on March 26, 2020. The latest expansion in the EUA will become the third amendment of the EUA following previous changes by the US FDA on March 24, 2020 and April 20, 2020.

In each case, the EUA has been amended with the intention of facilitating workflow flexibility and increasing throughput, allowing scientists to carry our more tests. The latest expansion means that labs can now run tests on specific configurations of QuantStudio 5 and QuantStudio 7 Flex real-time PCR instruments in addition to the previously approved Applied Biosystems 7500 real-time PCR series.

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The expansion also adds alternative RNA extraction reagents – including Thermo Fisher Scientific’s MagMAX viral/pathogen II nucleic isolation kit – as well as a range of microplate options to increase the number of possible sample purification methods.

Marc Casper (Chairman, President and CEO of Thermo Fisher Scientific) commented: “Increasing COVID-19 testing is a top priority in re-opening global economies. With this expanded authorization, additional instrumentation can be brought on line in labs around the world and the number of tests they can run will increase, which will help to support the need for more testing as people start returning to work.”

Sources: https://thermofisher.mediaroom.com/2020-05-12-FDA-Further-Expands-EUA-for-Thermo-Fisher-Scientifics-COVID-19-Diagnostic-Tests; www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019

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