Roche to launch SARS-CoV-2 Rapid Antigen Test, allowing fast triage decisions at POC

Sept. 3, 2020

Roche has announced that it will launch a SARS-CoV-2 Rapid Antigen Test in late September for markets accepting the CE Mark, according to a press release from the company. Roche also intends to file for Emergency Use Authorization (EUA) to 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. In addition, 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 96.5 percent and a specificity of 99.7 percent, based on 426 samples from two independent study centers. 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, with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July.

The test is the tenth addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.

The SARS-CoV-2 Rapid Antigen Test is performed by healthcare professionals in a number of different settings close to the patient. This is highly beneficial where timely decisions are needed, or laboratory testing is inaccessible. The test will help to quickly identify people who are infected and allows better patient management as well as more effective use of healthcare resources.

Visit Roche for more news