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Thermo Fisher Receives EU Approval For Diagnostic Test To Detect COVID-19

Thermo Fisher Scientific Inc. (TMO) said that it has received the CE mark in the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

The Thermo Fisher test, which uses Applied Biosystems TaqPath Assay and real-time PCR technology, 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 Scientific received Emergency Use Authorization by the U.S. Food and Drug Administration for its COVID-19 test on March 13, 2020. The authorization was amended on March 24, 2020, to include additional instruments, such as the company's Applied Biosystems 7500 Fast Real-Time PCR System.

In addition, Thermo Fisher's diagnostic test has received the designated approvals in Canada, Singapore, India, Australia and New Zealand.

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