Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced its plans to launch the SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets accepting the CE Mark by the beginning of January. Roche also intends to file for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) in early 2022.
The SARS-CoV-2 & Flu A/B Rapid Antigen Test is intended for use by healthcare professionals to rapidly differentiate between SARS-CoV-2 and influenza viruses A and B infections in individuals with symptoms consistent with COVID-19 or influenza. The single integrated combination test uses a nasopharyngeal swab specimen to produce qualitative results (“yes/no” answer) on the presence of SARS-CoV-2 and/or influenza A and/or B antigens in 15-30 minutes. The test has a relative sensitivity of 84.85% and specificity of 98.59% for SARS-CoV-2. For the flu, the test has a positive percent agreement of 81.16% (influenza virus A) and 100% (influenza virus B) against a molecular test, and relative specificity of 100% (influenza virus A) and 99.04% (influenza virus B). The currently available sequences of the Omicron variant SARS-CoV-2 (B.1.1.529) have been analyzed, and based on the initial in silico investigations, an impact on the performance of the test is not expected.
Equipping healthcare professionals with a single integrated combination test is beneficial in settings where timely clinical decisions are needed or where central laboratory testing is difficult to access. The SARS-CoV-2 & Flu A/B Rapid Antigen Test helps healthcare professionals at the point of care to quickly diagnose and differentiate infections with any of the three respiratory viruses and aid in pursuing appropriate courses of action, including patient and pandemic management decisions.
Thomas Schinecker, CEO of Roche Diagnostics, stated, “It is critical that healthcare professionals have the ability to quickly know whether a patient has an infection with either SARS-CoV-2 or the flu, especially as the COVID-19 pandemic extends into our flu season. The combination rapid antigen test will help ensure the right decisions are taken by healthcare providers to treat patients and ultimately prevent community spread. The test adds a solution that will be critical to healthcare systems’ long-term management of SARS-CoV-2 and seasonal flu, as we transition from today’s global health emergency to the endemic phase of tomorrow.”
Together with the SARS-CoV-2 & Flu A/B Rapid Antigen Test, Roche is offering NAVIFY® Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status. With a unique and personalised data matrix placed on the test, NAVIFY® Pass can automatically read out all details about the test and establish a connection between patients and their individual test results.
The launch will be in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and previously launched the SARS-CoV-2 Rapid Antigen Tests (Nasopharyngeal/Nasal), SARS-CoV-2 Antigen Self Test Nasal, and SARS-CoV-2 Rapid Antibody Test in countries accepting the CE Mark throughout 2020 and 2021. The test will become the fifth rapid test and twenty-second addition to Roche’s comprehensive portfolio of diagnostic solutions to help healthcare systems across the globe combat the COVID-19 pandemic through laboratory testing and at the point of care. Roche Diagnostics’ portfolio includes a wide range of molecular, serological and digital solutions that help diagnose and manage COVID-19 during the initial stages of infections, during the recovery phase, and following the resolution of infection.