The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche for its cobas® SARS-CoV-2 Test. The cobas® SARS-CoV-2 Test is designed to test asymptomatic individuals suspected to have COVID-19. The Center for Disease Control (CDC) conducted a study that found approximately half the transmission of all COVID-19 cases are estimated to be linked to asymptomatic individuals, making Roche’s test crucial for improving public health and safety.
The cobas® SARS-CoV-2 Test is currently available in the European Economic Area (EEA) as well as other countries that accept CE Marking. Cindy Perettie, Head of Molecular Lab, Roche Diagnostics Solutions, stated, “One of the key strategies to reduce COVID-19 transmission is to stop the silent spread of disease early. Expanding highly sensitive testing to include people who are at risk of exposure but do not show symptoms will help guide contact tracing, isolation and surveillance requirements, which are crucial for public health and the safe reopening of communities.”
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