Roche receives FDA EUA to test people who are asymptomatic for COVID-19

May 20, 2021

Roche announced that its cobas SARS-CoV-2 Test has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for testing individuals without symptoms or reasons to suspect COVID-19.

The test is for use on Roche’s cobas 6800/8800 Systems.

This authorization applies to pooled samples containing up to and including six individual samples.

“One of the key strategies to reduce COVID-19 transmission is to stop the silent spread of disease early,” said Cindy Perettie, Head of Molecular Lab, Roche Diagnostics Solutions. “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.”

Asymptomatic testing with the cobas SARS-CoV-2 Test is also available in countries accepting the CE mark.

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