Roche announced CE marking for its Cobas hepatitis D test and plans to launch in countries that accept the designation. The test is designed to detect and quantify hepatitis D virus RNA using fully automated Cobas 5800, 6800, and 8800 systems. Hepatitis D can only infect individuals already carrying hepatitis B, and co-infection or super-infection can lead to liver failure and liver cancer. Roche’s commercialization plan targets high-throughput settings that depend on automation to sustain turnaround time and testing capacity. The CE clearance supports expansion of viral diagnostics infrastructure in Europe, where HD management increasingly depends on reliable molecular quantification to inform clinical decision-making.