Roche, Basel, Switzerland, will launch a covid-19 rapid antigen test in late September for markets accepting the CE Mark. Roche also intends to file for emergency use authorization (EUA) to the FDA. The SARS-CoV-2 Rapid Antigen Test is for use in point-of-care 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.1 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 96.52% and a specificity of 99.68%, 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 Inc., 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.

“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” says Thomas Schinecker, CEO of Roche Diagnostics. “Covid-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the covid-19 virus. We are working relentlessly to deliver solutions that help alleviate some of the healthcare burden with reliable SARS-CoV-2 testing solutions as we learn more about the disease and how it affects people around the world.”

For more information, visit Roche.


[1] Roche Diagnostics Ltd. (2020). SARS-CoV-2 Rapid Antigen Test package insert * Evaluation was carried out in study centers in India and Brazil.