EU gives CE mark approval to SARS-CoV-2 test for Coronavirus.- Thermo Fisher

Thermo Fisher Scientific Inc announced 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.

Thermo Fisher Scientific received Emergency Use Authorization by the U.S. Food and Drug Administration for its COVID-19 test. This authorization was amended on March 24, 2020, to include additional instruments, such as the company’s Applied Biosystems 7500 Fast Real-Time PCR System. This expands testing capabilities in the U.S. from approximately 1,000 instruments to more than 3,000 instruments on which Thermo Fisher’s diagnostic test can be run.