Roche AG (RO), a Swiss multinational healthcare company, said on Monday that it plans to launch SARS-CoV-2 and Flu A/B Rapid Antigen Test for professional use in markets accepting the CE Mark by the beginning of January.
The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, the Basel-headquartered company said in a statement.
In addition, Roche aims to file for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) in early 2022, for its newly manufactured rapid antigen test kits.
The SARS-CoV-2 and 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, Roche noted.
The proposed launch is expected to be in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement.