Roche Launches cobas MPX-E Assay for 4-in-1 Blood Donor Screening

This approach is expected to improve operational efficiency, reduce turnaround time, and lower overall testing costs, while enhancing the safety of blood and blood products.

Roche has launched the cobas MPX-E assay, a multiplex in-vitro diagnostic test designed to detect and differentiate four major blood-borne viruses simultaneously, HIV (types 1 and 2), Hepatitis C (HCV), Hepatitis B (HBV), and Hepatitis E (HEV). The test is now available in countries that accept the CE mark.

The assay consolidates donor screening into a single workflow, enabling laboratories to generate four critical results from a single test. This approach is expected to improve operational efficiency, reduce turnaround time, and lower overall testing costs, while enhancing the safety of blood and blood products.

The cobas MPX-E assay runs on Roche’s fully automated cobas x800 systems, including cobas 6800/8800 and cobas 5800 platforms, which collectively process more than 10 million tests per month globally. The system enables high-throughput screening with up to eight hours of walk-away time, allowing laboratory staff to manage workloads more efficiently.

A key feature of the assay is its ability to integrate HEV screening into routine donor testing without requiring additional instrumentation or lab space. Hepatitis E remains a significant global health concern, with an estimated 20 million infections and 70,000 deaths annually. Since many carriers are asymptomatic, screening plays a critical role in preventing transmission through blood transfusions.

The test also incorporates dual-target detection for HIV-1 group M, targeting two regions of the viral genome to improve sensitivity and maintain accuracy even in the presence of viral mutations.

According to Roche Diagnostics CEO Matt Sause, the assay is designed to support timely and safe access to blood products by combining the detection of key viral pathogens within a single, integrated solution.

The global nucleic acid testing (NAT) blood screening market is valued at approximately 800 million CHF and is projected to grow at a compound annual growth rate of around 2% between 2024 and 2029.

The cobas MPX-E assay offers flexible testing configurations, allowing laboratories to screen for all four viruses simultaneously or select individual targets based on specific requirements, supporting scalability in high-volume testing environments.

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