Roche Launches First Automated cobas HDV Test

Roche has launched the cobas HDV test, the first high-throughput, fully automated hepatitis D virus (HDV) RNA assay on the market. Announced on 15 July 2026 as CE-marked, the assay runs on Roche’s cobas 5800, 6800 and 8800 systems and lands at a critical moment as new treatments for hepatitis D become available across multiple markets, creating clinical demand for consistent detection and treatment monitoring.

Hepatitis D affects approximately 12 million people worldwide and is considered the most aggressive form of viral hepatitis, often progressing to liver failure and hepatocellular carcinoma faster than other hepatitis types. HDV is a ‘satellite virus’ that can only infect people who already carry the hepatitis B virus. Co-infection with both viruses can account for around one in five cases of liver disease, while super-infection with HDV in patients with chronic hepatitis B is particularly aggressive, becoming chronic in over 90% of cases. Testing has historically relied on manual methods or lab-developed tests with variable consistency.

The cobas HDV test delivers detection and quantification of HDV RNA on the same fully automated cobas 5800/6800/8800 platforms that Roche uses across its established virology portfolio. Existing users can integrate the assay into their current workflows without hardware changes, an important operational consideration for centralised diagnostic laboratories. Matt Sause, CEO of Roche Diagnostics, framed the launch as another step in Roche’s commitment to improving outcomes for people living with liver disease, and as a platform for supporting the emerging class of HDV-specific therapies with the precise monitoring they require.

The commercial signal is Roche building the diagnostic infrastructure for the emerging HDV therapy market at exactly the moment specific treatments are reaching clinicians. With bulevirtide from Gilead already approved in the EU and additional HDV programmes advancing in the pipelines of Eiger BioPharmaceuticals and others, an automated companion diagnostic strengthens Roche’s virology diagnostics franchise against Abbott and QIAGEN in molecular infectious disease testing.

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