COVID-19 news: Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use
On March 13th, Roche, one of the Coalition's partners, announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test.
Key highlights of this test include:
- First commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs
- Testing on widely available, high-volume cobas 6800/8800 in reference laboratories will significantly increase available testing capacity: results in 3.5 hours and up to 1,440-4,128 results per day
- Upon authorization Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems.
- Roche has expedited test development to support urgent need for patient testing during pandemic outbreak to avoid a further spread of the virus at an early stage of infection
- The test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.
For more information, see: https://www.roche.com/media/releases/med-cor-2020-03-13.htm