On Mar. 26, 2020, Thermo Fisher Scientific announced it had received the CE mark in the European Union (EU) 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.

This CE mark represents Thermo Fisher’s assurance that 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.