Roche announced that it would 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 Authorisation (EUA) to the US Food and Drug Administration (FDA).
The SARS-CoV-2 Rapid Antigen Test is used 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. It also serves as a valuable initial screening test for individuals 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 test healthcare systems’ demands 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 that help diagnose and manage Covid-19 during the initial stages of infection, during the recovery phase, and following the resolution of infection.
The SARS-CoV-2 Rapid Antigen Test is performed by healthcare professionals in several 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 allow better patient management and more effective use of healthcare resources.
Thomas Schinecker, chief executive officer of Roche Diagnostics, stated, “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. 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.”
