Research & Development
Thermo Fisher wins CE Mark for diagnostic test to detect COVID-19 across the EU; provides update on other designated approvals
27 March 2020 -

Science products and services provider Thermo Fisher Scientific Inc (NYSE:TMO) revealed on Thursday 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.

Utilising the company's Applied Biosystems TaqPath Assay and real-time PCR technology, the test is designed to provide patient results within four hours of a sample being received by a lab, including the time for sample preparation and instrument analysis.

With the CE mark, Thermo Fisher assures its test complies with the European Union's In vitro Diagnostic Directive, which applies to products that are manufactured in or designed to be sold in the European Economic Area.

Additionally, the company has passed the US FDA's amended Emergency Use Authorization for its COVID-19 test that includes Applied Biosystems 7500 Fast Real-Time PCR System, the MagMax Viral/Pathogen Nucleic Acid Isolation Kit as well as Applied Biosystems COVID-19 Interpretive Software, to expand testing in the US from about 1,000 instruments to about 3,000 .

Concurrently, the company's diagnostic test has received the designated approvals in Canada, Singapore, India, Australia and New Zealand.

Thermo Fisher has established an online resource to find up-to-date information about its response to the COVID-19 pandemic at https://corporate.thermofisher.com/en/COVID-19.html.

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