Roche Supports Hepatitis D Diagnosis and Treatment Monitoring With New Automated Assay

Roche Supports Hepatitis D Diagnosis and Treatment Monitoring With New Automated Assay

(IN BRIEF) Roche has introduced the cobas HDV test, the first high-throughput, fully automated assay for detecting and quantifying Hepatitis D Virus RNA. The test runs on the cobas 5800, 6800 and 8800 systems and is available in countries accepting the CE mark. Hepatitis D affects an estimated 12 million people worldwide and is considered the most severe form of viral hepatitis. It can only infect people who already have Hepatitis B and can occur either as a co-infection or super-infection, with super-infection carrying a high risk of becoming chronic and causing accelerated liver damage. Roche said the new test gives clinicians a reliable tool to identify infected individuals and monitor treatment response, while helping laboratories replace less consistent manual or lab-developed testing approaches with a fully automated workflow.

(PRESS RELEASE) BASEL, 14-Jul-2026 — /EuropaWire/ — Roche has introduced the cobas® HDV test for use on its cobas® 5800, 6800 and 8800 systems, offering healthcare providers a fully automated diagnostic solution for detecting and measuring Hepatitis D Virus RNA.

The test is available in countries that accept the CE mark and is designed to support clinicians in identifying patients with Hepatitis D and monitoring their response to treatment.

Hepatitis D is considered the most aggressive form of viral hepatitis and affects an estimated 12 million people worldwide. The disease can lead to liver failure and liver cancer more rapidly than other forms of viral hepatitis, making accurate and accessible testing an important part of patient care.

The cobas HDV test is the first high-throughput, fully automated HDV assay available on the market. Roche said the test addresses the need for a consistent and widely accessible diagnostic solution, particularly as new treatments for Hepatitis D become available in more markets.

Matt Sause, Chief Executive Officer of Roche Diagnostics, said the launch reflects Roche’s focus on 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 Sause.

Hepatitis D is a satellite virus, meaning it can only infect people who already have Hepatitis B Virus. It can occur as a co-infection, when a person is infected with both Hepatitis B and Hepatitis D at the same time, or as a super-infection, when Hepatitis D develops in someone already living with chronic Hepatitis B.

Roche noted that co-infection may account for around one in five cases of liver disease, while super-infection is particularly dangerous, with more than 90% of cases becoming chronic and progressing more rapidly to liver damage.

Despite the severity of Hepatitis D, testing has often relied on manual methods or laboratory-developed tests, which can vary in consistency. By introducing a fully automated assay, Roche aims to help laboratories improve reliability, efficiency and access to HDV testing.

The cobas HDV test runs on Roche’s cobas 5800, 6800 and 8800 systems, which are already used in laboratories worldwide. The automation of the testing process allows laboratories to integrate HDV testing into existing workflows and deliver accurate results more efficiently.

Roche said the new assay will help clinicians make timely decisions for patients, both during diagnosis and while monitoring treatment response.

About Hepatitis D
Hepatitis D leads to faster progression toward liver failure, cirrhosis, and liver cancer compared to other forms of hepatitis. Symptoms can be severe and include jaundice (yellowing of the skin and eyes), extreme fatigue, abdominal pain, and nausea. The virus is transmitted through contact with infected blood or bodily fluids. Because it requires Hepatitis B to replicate, vaccination against Hepatitis B is the most effective way to prevent Hepatitis D infection.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] World Health Organization factsheet on Hepatitis D, July 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d
[2] The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis. Stockdale, Alexander J. et al. Journal of Hepatology, Volume 73, Issue 3, 523 – 532
[3] Bardak AE, Ozturk NB, Gurakar M, Sequeira L, Yildiz E, Ozmert EH, Idilman R, Gurakar A. Updates on Recent Advancements in Hepatitis D Virus Treatment. Viruses. 2025 Aug 10;17(8):1100. doi: 10.3390/v17081100. PMID: 40872814; PMCID: PMC12390690.

Media Contact:

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

SOURCE: Roche