Roche introduces first fully automated cobas Hepatitis D Virus test to diagnose the most severe form of viral hepatitis

Roche has introduced the cobas^® Hepatitis D Virus (HDV) test for use on the cobas^® 5800/6800/8800 systems in countries accepting the CE mark. This high-throughput, fully automated molecular diagnostic assay detects and quantifies HDV RNA, enabling clinicians to identify patients with the most aggressive form of viral hepatitis and monitor their response to newly available treatments.

First fully automated, high-throughput HDV assay

Until now, HDV testing has often relied on manual methods or laboratory-developed tests that can vary in performance and consistency. The cobas HDV test is the first high-throughput, fully automated HDV assay available on the market, designed to address the urgent need for a standardised, widely accessible diagnostic solution.

By providing a consistent and scalable approach to HDV RNA detection and quantification, the cobas HDV test supports accurate diagnosis and ongoing monitoring of patients with hepatitis D. This is particularly important as specific HDV treatments become available in many markets, requiring precise viral load measurements to assess treatment response and guide clinical decisions.

Seamless integration on cobas 5800/6800/8800 systems

The cobas HDV test runs on the fully automated cobas 5800/6800/8800 systems, which are already widely implemented in clinical laboratories around the world. These molecular testing platforms enable laboratories to integrate HDV testing into existing workflows without major changes to infrastructure.

Automation of the testing process allows laboratories to deliver accurate and reproducible results quickly and efficiently. Faster turnaround times support clinicians in making timely decisions for patients with advanced liver disease, where early intervention can be critical.

Addressing the global burden of hepatitis D

Hepatitis D affects nearly 12 million people worldwide and is recognized as the most severe form of viral hepatitis, progressing more rapidly to liver failure, cirrhosis, and liver cancer than other hepatitis viruses.

HDV is a unique satellite virus that can only infect individuals who already have hepatitis B virus (HBV). It can present as a co-infection, where a person acquires HBV and HDV at the same time, or as a super-infection, where HDV infects someone with pre-existing chronic hepatitis B.

Co-infection may account for around 1 in 5 cases of liver disease, while super-infection is particularly dangerous, with over 90% of cases becoming chronic and accelerating liver damage. Because HDV relies on HBV to replicate, vaccination against hepatitis B remains the most effective strategy to prevent hepatitis D infection.

Supporting better outcomes in liver disease

By expanding access to HDV testing on a widely used, automated platform, Roche aims to support hepatologists, infectious disease specialists, and clinical laboratories in improving the diagnosis and management of hepatitis D. The combination of standardized testing and emerging targeted therapies has the potential to significantly improve outcomes for people living with this severe form of viral hepatitis.

“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.”

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