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Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA

NEW YORK – Thermo Fisher Scientific said on Thursday that it has received the CE mark for its COVID-19 diagnostic test.

The test, which uses an Applied Bioystems TaqPath assay and real-time PCR technology, detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19. It provides patient results within four hours of a sample being received by a lab, which include sample prep and analysis.

With the CE mark, the test is now available to qualified laboratories in the European Union and other countries in the European Economic Area.

Thermo Fisher also said that the US Food and Drug Administration has expanded its Emergency US Authorization for the test, which the company received earlier this month. The updated EUA adds manual sample extraction using the MagMax viral/pathogen nucleic acid isolation kit, the Applied Biosystems 7500 Fast real-time PCR system that utilizes DCS versions 1.5.1 and 2.3, the Applied Biosystems COVID-19 interpretative software v1.1, and other format changes and minior edits.