Roche has announced the availability of its cobas MPX-E assay, a qualitative in-vitro diagnostic test designed to simultaneously detect and differentiate HIV-1, HIV-2, Hepatitis B, C, and E viruses. Now accessible in CE mark–accepting countries, the assay marks a significant advancement in blood donor screening by integrating multiple viral targets into a single, streamlined workflow.
The cobas MPX-E assay enhances laboratory efficiency while strengthening the safety of blood and blood products. By consolidating testing for four major pathogens, it reduces operational complexity and improves turnaround times, addressing the growing demand for reliable and scalable diagnostic solutions.
According to Matt Sause, CEO of Roche Diagnostics, the launch supports safer and more timely access to blood products by offering a fully integrated solution that improves both detection capabilities and lab productivity.
A key feature of the assay is its enhanced sensitivity and specificity, particularly for Hepatitis E virus (HEV), which accounts for an estimated 20 million infections and 70,000 deaths globally each year. Since many HEV carriers remain asymptomatic, advanced screening solutions are critical to safeguarding blood supplies.
The assay also incorporates dual-target detection for HIV-1 group M, improving reliability even in the presence of viral mutations. Built on multiplex real-time PCR technology, it enables simultaneous detection of multiple pathogens while allowing laboratories the flexibility to test individual targets as needed.
Designed for use on Roche’s fully automated cobas x800 systems—including cobas 5800, 6800, and 8800—the assay supports high-throughput testing environments, with laboratories globally already running over 10 million tests per month on these platforms. Automation features, including ready-to-load reagents and up to eight hours of walk-away time, help optimize workforce efficiency.
With the global nucleic acid testing (NAT) market valued at approximately CHF 800 million and projected to grow at a CAGR of 2 Percent from 2024 to 2029, the launch underscores Roche’s commitment to advancing diagnostics manufacturing through innovation, scalability, and operational efficiency.
Roche continues to leverage its integrated expertise across diagnostics, pharmaceuticals, and digital health to deliver cutting-edge solutions aimed at improving patient outcomes and transforming disease management worldwide.
