Roche Advances Molecular Diagnostics Portfolio with Integrated cobas MPX-E Solution for Modern Blood Screening

Roche Advances Molecular Diagnostics Portfolio with Integrated cobas MPX-E Solution for Modern Blood Screening

(IN BRIEF) Roche has launched the cobas MPX-E assay, a multiplex molecular diagnostic test capable of detecting HIV, Hepatitis B, Hepatitis C, and Hepatitis E simultaneously in a single workflow. Available in CE mark–accepting markets, the assay is designed to improve blood donor screening by increasing efficiency, reducing costs, and enhancing safety. It incorporates advanced features such as dual-target detection for HIV-1 to ensure high sensitivity and reliability, even in the presence of viral mutations. The test runs on Roche’s automated cobas x800 systems, enabling high-throughput operations with up to eight hours of walk-away time. It also provides a convenient and cost-effective solution for laboratories looking to introduce or improve HEV screening, a critical need given the virus’s global impact and often asymptomatic nature.

(PRESS RELEASE) BASEL, 30-Mar-2026 — /EuropaWire/ — Roche has introduced a new addition to its molecular diagnostics portfolio with the launch of the cobas® MPX-E assay, now available in markets recognizing the CE mark. The test is a qualitative in-vitro diagnostic solution capable of simultaneously detecting and distinguishing four major viral pathogens—HIV (types 1 and 2), Hepatitis B, Hepatitis C, and Hepatitis E—within a single workflow, marking a notable step forward in blood donor screening.

By combining multiple targets into one assay, the cobas MPX-E enhances operational efficiency in laboratories while contributing to improved safety in blood transfusion practices. The ability to identify these viruses concurrently reduces the need for multiple individual tests, helping laboratories streamline processes and lower overall costs.

Matt Sause, CEO of Roche Diagnostics, emphasized the importance of reliable and timely blood screening, noting that ensuring safe access to blood products remains fundamental to modern healthcare systems. The new assay is positioned as a comprehensive and integrated solution designed to improve both testing performance and laboratory productivity.

The cobas MPX-E assay addresses emerging diagnostic needs by incorporating highly sensitive and specific detection capabilities, particularly for Hepatitis E (HEV), a virus responsible for an estimated 20 million infections and approximately 70,000 deaths annually worldwide. Given that many HEV infections are asymptomatic, routine screening is essential to mitigate risks associated with blood transfusions.

A key technical feature of the assay is its dual-target detection approach for HIV-1 group M, which examines two separate regions of the viral genome. This design increases detection reliability, even in cases where viral mutations might otherwise affect test accuracy.

Designed for use on the fully automated cobas® x800 systems—including cobas® 6800/8800 and cobas® 5800—the assay supports high-throughput screening environments. These systems are widely adopted globally, collectively processing more than 10 million tests each month. The new test allows laboratories to operate with up to eight hours of walk-away time, reducing manual intervention and enabling staff to focus on other critical tasks.

In addition to improving efficiency, the cobas MPX-E assay delivers faster turnaround times for laboratories already performing HEV screening. For facilities not yet screening for HEV, the assay offers a practical and cost-effective entry point, as it can be implemented without requiring additional equipment or laboratory space.

The global market for Nucleic Acid Testing (NAT) in blood screening is valued at approximately 800 million Swiss francs, with projected steady growth over the coming years. Within this context, the introduction of the cobas MPX-E assay reflects ongoing efforts to enhance diagnostic capabilities while supporting scalable and efficient laboratory operations.

About the cobas MPX-E assay
The cobas MPX-E assay is a multiplex real-time PCR test for the simultaneous detection and discrimination of HIV, HCV, HBV, and HEV in distinct channels. It is designed for use on the cobas x800 family of systems, offering a scalable solution that allows multiple tests to be run simultaneously at the same time. The assay offers flexible testing options, allowing laboratories to test for all four targets or select single targets based on their specific screening requirements. The ready-to-load reagents and automation allow for up to eight hours of walk-away time, freeing up laboratory staff for other critical tasks.

For laboratories currently screening for HEV, this assay offers faster turnaround times. For those looking to implement HEV screening, the cobas MPX-E provides a cost-effective solution that does not require additional floor space or instrumentation

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] Klöhn M, Schrader JA, Brüggemann Y, Todt D, Steinmann E. Beyond the Usual Suspects: Hepatitis E Virus and Its Implications in Hepatocellular Carcinoma. Cancers (Basel). 2021 Nov 22;13(22):5867. doi: 10.3390/cancers13225867. PMID: 34831021; PMCID: PMC8616277.
[2] FY24 IQVIA Diagnostics market book

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SOURCE: Roche