Skip to main content

Roche Expects CE Mark for SARS-CoV-2 Rapid Antigen Test

NEW YORK – Roche announced Tuesday that its SARS-CoV-2 rapid antigen test will receive CE marking in late September and will then launch in countries accepting such designation.

The point-of-care test, which is Roche's 10th COVID-19 test, doesn't require an instrument and returns results in 15 minutes, the company said. It is intended for use in both symptomatic and asymptomatic patients, a key difference from Abbott's recently launched antigen test, which is only authorized for use in symptomatic patients. Roche's SARS-CoV-2 Rapid Test has a sensitivity of 96.5 percent and specificity of 99.7 percent based on nasopharyngeal samples from two study centers, the Basel, Switzerland-based company noted.

The launch is a partnership with SD Biosensor, with whom Roche has a global distribution agreement. Roche said it also plans on filing for Emergency Use Authorization with the US Food and Drug Administration. Upon launching the rapid chromatographic test, the company said it will have 40 million available per month, with plans to double capacity by the end of 2020.

After Roche's announcement other diagnostic firms' stock prices fell, although they have since rebounded slightly. Quidel's share price dropped 10 percent, GenMark Diagnostics' stock price dropped 7 percent, and Fluidigm's price dropped 6 percent. Quidel's rapid antigen test was the first to receive EUA from the FDA earlier this year.