Roche announced on June 18, 2024, that its Elecsys HCV Duo immunoassay has received CE Mark approval, allowing its commercial launch in countries accepting the CE Mark. The Elecsys HCV Duo is designed for the simultaneous detection of hepatitis C virus (HCV) antigens and antibodies in human serum and plasma.

This dual marker approach enables earlier detection of HCV infection compared to antibody-only tests, supporting timely diagnosis and intervention. The assay is compatible with Roche’s cobas e analyzers, facilitating integration into existing laboratory workflows.

With this approval, laboratories across Europe and other CE Mark-accepting regions can now access a new tool for improving HCV screening and diagnosis, aligning with global efforts to combat viral hepatitis.