Roche receives FDA authorisation for testing of asymptomatic people

Roche today announced that its cobas® SARS-CoV-2 Test for use on the widely available, high-throughput cobas® 6800/8800 Systems has received Emergency Use Authorisation from the U.S. Food and Drug Administration (FDA) for testing individuals without symptoms or reasons to suspect COVID-19. This authorisation supports the guidance update from the U.S. Centers for Disease Control and Prevention to expand SARS-CoV-2 testing to include people without symptoms1 in an effort to reduce the spread of disease, and applies to pooled samples containing up to and including six individual samples.

A study conducted by the CDC has shown that transmission of COVID-19 by individuals who do not exhibit symptoms is estimated to be responsible for more than half of all infected cases.2 This presents a significant public health challenge as symptom-based testing alone is not sufficient to effectively control the spread of COVID-19.

“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. In 2020 Roche enabled 160 million molecular SARS-CoV-2 tests on the company’s platforms in an extraordinary scale-up effort, and the company continues to develop innovative diagnostic solutions to help healthcare professionals understand and manage the disease. PR Newswire