This story has been updated to clarify that Roche has not yet received CE marking for the test. We regret the error.
NEW YORK – Roche announced on Monday that it plans to launch its combo SARS-CoV-2 and influenza A/B rapid antigen test for professional use upon receiving CE marking.
The firm said in a statement it plans to launch the test, in partnership with South Korean firm SD Biosensor, in countries accepting the CE mark at the start of January. It also intends to file for Emergency Use Authorization with the US Food and Drug Administration in early 2022.
Roche has previously launched its SARS-CoV-2 Rapid Antigen Tests, SARS-CoV-2 Antigen Self Test Nasal, and SARS-CoV-2 Rapid Antibody Test in CE-marked countries with the South Korean company.
The new qualitative test differentiates between SARS-CoV-2 and influenza A/B using a nasopharyngeal swab sample, providing results within 30 minutes, and doesn't require an instrument. It is intended for use by healthcare professionals within the first five days of symptom onset, the firm said.
It has a sensitivity of 84.85 percent and a specificity of 98.59 percent for SARS-CoV-2, the company said. For influenza A, it has a positive percent agreement of 81.16 percent and relative specificity of 100 percent, while for influenza B it has a PPA of 100 percent and relative specificity of 99.04 percent.
The Basel, Switzerland-based company also noted that the test's performance isn't affected by the Omicron variant of SARS-CoV-2, based on initial in silico investigations using currently available sequences of the variant.
"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," Roche Diagnostics CEO Thomas Schinecker said in a statement.