FDA Grants EUA for COVID-19 Testing for Asymptomatic People

Roche’s cobas SARS-CoV-2 Test was granted Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and can be employed to test individuals without symptomatic disease.

The announcement was made yesterday and supports the guidance update from the US Centers for Disease Control and Prevention (CDC) to expand SARS-CoV-2 testing to include people without symptoms.

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

The cobas SARS-CoV-2 Test for use on the cobas 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in healthcare provider-instructed self-collected anterior nasal (nasal) swab specimens (collected on site), and healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens collected from any individuals, including those suspected of COVID-19, and those without symptoms or other reasons to suspect COVID-19.

According to Roche, the cobas SARS-CoV-2 Test for asymptomatic people testing with is available in countries accepting the CE mark as well.