Fully Automated Test Advances Hepatitis D Diagnosis and Monitoring

Because hepatitis D depends on co-infection or superinfection with hepatitis B virus, clinicians need reliable assays to confirm active infection and assess treatment response. Access to standardized, scalable testing has often been limited by manual methods or variable laboratory-developed tests. A newly launched test now provides fully automated, high-throughput detection and quantification of hepatitis D virus RNA to support diagnosis and ongoing management

Roche has introduced the cobas HDV test for use on the cobas 5800/6800/8800 systems in countries that accept the CE mark. The assay is intended for the detection and quantification of Hepatitis D virus (HDV) RNA to aid clinicians in diagnosing infection and monitoring response to therapy. It is described as the first high-throughput, fully automated HDV assay on the market, expanding access to consistent, standardized testing as new treatments become available.

The cobas HDV test runs on the fully automated cobas 5800/6800/8800 molecular platforms already deployed in clinical laboratories worldwide. By integrating HDV quantification into these systems, laboratories can incorporate testing within existing workflows without additional standalone processes. The automated workflow is designed to improve consistency while enabling faster and more efficient result delivery to support timely clinical decisions.

Roche states that the assay will be available in countries that recognize the CE mark. The company positions the test for both initial identification of infected individuals and follow-up quantification to monitor therapeutic response over time. These applications align with growing clinical demand for standardized HDV viral load assessment as disease-specific therapies become available in more markets.

HDV is characterized in the release as the most aggressive form of viral hepatitis and is estimated to affect nearly 12 million people globally. Because HDV requires Hepatitis B virus (HBV) to replicate, infection may occur as a co-infection (simultaneous HDV and HBV) or as a super-infection in individuals with chronic HBV. Super-infection is described as particularly dangerous, with a high likelihood of chronicity and more rapid progression to liver damage.

“This is an important advancement of our commitment to improving outcomes for people living with liver disease. 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,” said Matt Sause, CEO of Roche Diagnostics.