Roche Receives FDA EUA for Testing of Asymptomatic People with High-Throughput, Highly Sensitive Cobas SARS-CoV-2 Test

Roche (Basel, Switzerland) has announced that its cobas SARS-CoV-2 Test for use on its high-throughput cobas 6800/8800 Systems has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for testing individuals without symptoms or reasons to suspect COVID-19.

The authorization 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 in an effort to reduce the spread of disease, and applies to pooled samples containing up to and including six individual samples.


The cobas SARS-CoV-2 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 by their healthcare provider, and those without symptoms or other reasons to suspect COVID-19.

The test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples from healthcare provider-instructed self-collected nasal swab specimens (collected on site), or healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens.

"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."