Roche to Launch 15-Minute COVID-19 Rapid Antigen Test in Europe and File for EUA in US

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

The launch is a partnership with SD Biosensor Inc. (Seoul, Korea), with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. The test is the 10th 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 intended for both symptomatic and asymptomatic people, and is performed by healthcare professionals in a number of different point-of-care settings close to the patient. This is highly beneficial where timely decisions are needed or laboratory testing is inaccessible. The rapid chromatographic immunoassay is intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx and is performed by healthcare professionals using a nasopharyngeal swab collected from a patient. The test can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes, and allow better patient management as well as more effective use of healthcare resources. 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.

“As the COVID-19 pandemic persists, healthcare systems remain challenged. Testing continues to be an important focus for many countries. 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,” said 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.”