Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE Mark

September 2, 2020  –  Roche (Basel, Switzerland) announced it will launch a SARS-CoV-2 Rapid Antigen Test in late September for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA).

The SARS-CoV-2 Rapid Antigen Test is for use in point-of-care (POC) settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.

Additionally, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers, Roche says.

At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month. This capacity will increase more than two-fold at the end of this year to help with testing demands of healthcare systems globally.

The launch is a partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July.

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