Roche has announced the launch of its next-generation portfolio SARS-CoV-2 rapid antigen tests (“2.0”) for self-testing and professional use in countries accepting the CE Mark. Distribution of the new rapid test portfolio is projected to begin in the coming weeks.
In doing so, Roche builds upon one of the broadest portfolios of COVID-19 rapid testing solutions with three new test configurations that feature enhanced performance through the use of an improved capture antibody and the addition of new digital data sharing capabilities to all tests. Using nasopharyngeal and nasal swab samples, respectively, the tests deliver reliable results in as little as 15 minutes, aiding in the diagnosis of SARS-CoV-2 infection in individuals with or without symptoms consistent with COVID-19.
“The continued evolution of the SARS-CoV-2 virus and COVID-19 pandemic reinforce the need for individuals and healthcare systems to have access to the most reliable rapid testing solutions possible,” said Thomas Schinecker, CEO, Roche Diagnostics. “As a leader in diagnostic innovation, we are proud to be one of the first among our industry to apply insights gained from the past two years toward a next-generation rapid-test portfolio. These tests are ready to support global society as we navigate this next phase of the pandemic.”
The three tests set to launch are the following:
Professional use:
● SARS-CoV-2 Rapid Antigen Test 2.0 (nasopharyngeal sampling)
● SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (nasal sampling)
Self-Test:
● SARS-CoV-2 Antigen Self Test Nasal (nasal sampling)
Roche maintains the capacity to provide several tens of millions of each of the tests per month, with the option to quickly build up additional capacity if needed, to address sustained high worldwide demand for rapid testing from governments, healthcare systems and individuals. The next-generation test portfolio will be introduced in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and previously launched a range of rapid antigen and antibody tests in more than 50 countries worldwide.
The tests join Roche Diagnostics’s broader COVID-19 portfolio, which includes a wide range of molecular, serological 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.
Laboratory testing showed that all three tests can qualitatively detect major variants of concern including Delta and Omicron variants. Emerging variants are continuously monitored.
Roche has developed and launched more than 20 COVID-19 diagnostics solutions, including polymerase chain reaction (PCR) and rapid antigen and antibody tests. The company has supplied more than 1.5 billion tests for COVID-19 since March 2020.
For more information, please visit Roche’s COVID-19 response page at https://www.roche.com/topic/covid-19