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May 13, 2020

US FDA expands EUA for Thermo Fisher Scientific’s Covid-19 test

The US Food and Drug Administration (FDA) has expanded emergency use authorisation (EUA) for Thermo Fisher Scientific's Applied Biosystems TaqPath Covid-19 test kit.

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The US Food and Drug Administration (FDA) has expanded emergency use authorisation (EUA) for Thermo Fisher Scientific’s Applied Biosystems TaqPath Covid-19 test kit.

The multiplex real-time PCR test can be used for the qualitative detection of nucleic acid from SARS-CoV-2 virus, which causes Covid-19.

The test initially received EUA on 13 March, which was subsequently expanded last month. The third expansion increases the number of high-throughput PCR instruments that labs can use to run tests.

Additionally, it offers improved flexibility in testing workflows by providing new options for reagents and consumables used in sample preparation and extraction.

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The expanded EUA also adds the company’s MagMAX viral/pathogen II nucleic isolation kit as an alternative to increase the availability of RNA extraction reagents. Moreover, the updated sample purification step enables a variety of microplate options.

Thermo Fisher Scientific president, chairman and CEO Marc Casper said: “Increasing Covid-19 testing is a top priority in re-opening global economies.

“With this expanded authorisation, additional instrumentation can be brought online 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.”

The labs can now run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Real-time PCR instruments, in addition to the previously approved Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5.

This significantly increases the number of instruments available for testing.

Last month, the company launched AcroMetrix Coronavirus 2019 (Covid-19) RNA Control to monitor and validate Covid-19 molecular diagnostic tests.

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