Roche’s Hepatitis D Virus test, the first fully automated diagnostic tool for identifying the most severe form of viral hepatitis

Roche has unveiled the cobas HDV test for use on its cobas 5800, 6800, and 8800 systems, a diagnostic tool for detecting and quantifying Hepatitis D Virus RNA in countries accepting the CE mark. Running on Roche’s widely deployed cobas platforms, the test is designed to help healthcare providers identify infected patients and monitor their care more effectively alongside newly emerging treatment options.

“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, which is estimated to affect around 12 million people globally, operates as a satellite virus, meaning it can only take hold in individuals already carrying the Hepatitis B virus. This dependency gives rise to two distinct patterns of infection: co-infection, where both viruses are acquired simultaneously, and super-infection, where Hepatitis D develops in someone already living with chronic Hepatitis B. Co-infection has been linked to roughly one in five cases of liver disease, while super-infection carries an even greater risk, with over 90% of cases becoming chronic and accelerating the pace of liver damage.

Despite how serious the condition can be, testing has historically depended on manual methods or laboratory-developed assays that lack consistency. The cobas HDV test addresses this gap as the first high-throughput, fully automated HDV assay to reach the market, delivering a reliable and scalable solution at a particularly critical moment given that specific treatments for Hepatitis D are now becoming available in many markets and require precise monitoring to confirm they are working effectively.

The assay operates on the cobas 5800, 6800, and 8800 automated platforms, which are already embedded in laboratories around the world, making integration into existing workflows straightforward. By removing the manual steps from the testing process, laboratories can produce accurate results more quickly and efficiently, giving clinicians the timely information they need to make informed decisions for their patients.

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Related Topics and Keywords

Hepatitis, Hepatitis D Virus, Roche, viral hepatitis