BASEL, Switzerland, July 14, 2026
Roche has introduced the cobas® Hepatitis D Virus (HDV) test, the first fully automated, high-throughput molecular diagnostic assay designed to detect and quantify HDV RNA in patients infected with Hepatitis D Virus. Available in countries recognizing the CE mark, the assay runs on Roche’s cobas® 5800, 6800, and 8800 systems, providing laboratories with a standardized solution to diagnose HDV and monitor treatment response as new therapies for the disease become available.
First Fully Automated HDV Assay Addresses Major Diagnostic Gap
Hepatitis D is considered the most severe form of viral hepatitis, affecting an estimated 12 million people worldwide. Because HDV can only infect individuals already carrying Hepatitis B Virus (HBV), patients often experience accelerated progression to cirrhosis, liver failure, and liver cancer compared with other viral hepatitis infections. Until now, HDV testing has largely relied on manual or laboratory-developed methods that may vary in performance. Roche’s new assay provides the first fully automated, high-throughput testing solution, enabling more consistent and accessible diagnosis across routine clinical laboratories.
Automated Workflow Supports Faster Clinical Decision-Making
The cobas HDV test integrates directly into Roche’s widely deployed automated molecular diagnostic platforms, allowing laboratories to incorporate HDV testing into existing workflows without additional infrastructure. By automating RNA detection and quantification, the system delivers reliable and efficient results that help clinicians identify infected patients, assess viral burden, and monitor response to emerging antiviral therapies. The assay is designed to improve laboratory productivity while supporting timely clinical decision-making.
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Expanding Access to Advanced Hepatitis Diagnostics
Roche stated that the launch reflects its ongoing commitment to advancing infectious disease diagnostics through automated molecular testing. As specific therapies for Hepatitis D become increasingly available, accurate viral monitoring is expected to play an essential role in patient management. By providing standardized HDV RNA testing on globally established cobas systems, Roche aims to improve access to high-quality diagnostics and support better outcomes for patients living with one of the most aggressive forms of viral hepatitis.
Source: Roche,press release
