R&D
Roche launches first fully automated high-throughput Hepatitis D test in CE mark markets
The new test is designed to help healthcare providers identify HDV infections earlier
- By IPP Bureau
| July 16, 2026
Roche has launched the cobas HDV test for use on its cobas 5800/6800/8800 systems in countries accepting the CE mark, marking the introduction of the first fully automated, high-throughput diagnostic assay for the detection and quantification of Hepatitis D Virus (HDV) RNA.
The new test is designed to help healthcare providers identify HDV infections earlier and monitor patients more effectively, supporting clinical decision-making as new treatment options for the disease become increasingly available.
"This is an important advancement of our commitment to improving outcomes for people living with liver disease," said Matt Sause, CEO of Roche Diagnostics. "With the cobas HDV test, we are providing clinicians with a reliable tool to aid in the identification of infected individuals and to monitor their response to treatment."
Hepatitis D is a severe viral infection that affects an estimated 12 million people worldwide and can only occur in individuals already infected with the Hepatitis B virus (HBV). The virus may develop as either a co-infection with HBV or as a super-infection in people with chronic Hepatitis B.
While co-infection is linked to roughly one in five cases of liver disease, super-infection is particularly dangerous, with more than 90% of cases progressing to chronic disease and rapidly increasing the risk of liver damage.
Until now, HDV testing has largely relied on manual methods or laboratory-developed assays that may produce inconsistent results. Roche said its new cobas HDV test addresses this gap by providing a standardized, automated solution that can be integrated into laboratories already using the cobas 5800/6800/8800 systems.
The automated workflow is expected to improve laboratory efficiency while enabling faster, accurate test results, helping clinicians make timely treatment decisions and monitor patient response as HDV-specific therapies become more widely available.
