BASEL, Switzerland, March 30, 2026
Roche has announced the launch of its cobas® MPX-E assay, a next-generation 4-in-1 multiplex diagnostic test designed to enhance the safety and efficiency of blood donor screening worldwide. The assay simultaneously detects HIV, Hepatitis B (HBV), Hepatitis C (HCV), and Hepatitis E (HEV) in a single workflow, marking a significant advancement in in-vitro diagnostics and laboratory automation. The innovation is expected to improve screening accuracy, reduce turnaround times, and streamline laboratory operations, addressing critical global healthcare needs related to blood safety.
4-in-1 Multiplex Testing Enhances Blood Safety
The cobas MPX-E assay introduces a multiplex real-time PCR technology capable of detecting four major viral pathogens simultaneously, eliminating the need for multiple separate tests. This integrated approach not only improves laboratory efficiency but also significantly enhances the safety of blood transfusions, a cornerstone of modern healthcare systems.
One of the key innovations is the inclusion of Hepatitis E (HEV) detection, a virus responsible for an estimated 20 million infections and 70,000 deaths annually worldwide, often remaining undiagnosed due to asymptomatic carriers. By enabling HEV screening without additional instrumentation, the assay provides laboratories with a cost-effective and scalable solution to address previously unmet diagnostic needs.
Additionally, the assay incorporates dual-target detection for HIV-1, improving sensitivity and ensuring accurate detection even in cases of viral mutation. This advancement is crucial for maintaining high diagnostic reliability in evolving viral landscapes, reinforcing the assay’s role in safeguarding blood supplies globally.
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Clinical Evidence Demonstrates Strong Efficacy and Safety
The CHMP’s recommendation is based on robust Phase II/III clinical trial data, including a randomized, placebo-controlled, triple-blind study involving patients aged 12 years and older diagnosed with APDS. The trial demonstrated statistically significant improvements in immune dysregulation and immunodeficiency markers, validating the drug’s ability to address the underlying cause of the disease rather than just managing symptoms.
One of the key innovations is the inclusion of Hepatitis E (HEV) detection, a virus responsible for an estimated 20 million infections and 70,000 deaths annually worldwide, often remaining undiagnosed due to asymptomatic carriers. By enabling HEV screening without additional instrumentation, the assay provides laboratories with a cost-effective and scalable solution to address previously unmet diagnostic needs.
Additionally, the assay incorporates dual-target detection for HIV-1, improving sensitivity and ensuring accurate detection even in cases of viral mutation. This advancement is crucial for maintaining high diagnostic reliability in evolving viral landscapes, reinforcing the assay’s role in safeguarding blood supplies globally.
Automation and Efficiency Drive Laboratory Performance
Designed for use on Roche’s fully automated cobas x800 systems, including the cobas 6800/8800 and cobas 5800 platforms, the MPX-E assay enables high-throughput screening with minimal manual intervention. Laboratories can benefit from up to eight hours of walk-away time, allowing staff to focus on other critical tasks while maintaining continuous testing operations.
The assay’s flexible testing configuration allows laboratories to either run all four targets simultaneously or select specific targets based on their operational requirements. This flexibility supports a wide range of laboratory environments, from high-volume blood banks to specialized diagnostic centers.
Furthermore, the ability to consolidate multiple tests into a single workflow leads to reduced operational complexity, lower costs, and faster turnaround times, making it a valuable tool in addressing the increasing demand for efficient and scalable diagnostic solutions.
Strategic Impact on Global Diagnostics and Healthcare
The launch of the cobas MPX-E assay reflects Roche’s continued commitment to advancing diagnostic innovation and public health safety. As the global market for nucleic acid testing (NAT) blood screening continues to grow, this new assay positions Roche at the forefront of high-performance molecular diagnostics, with a focus on improving both clinical outcomes and laboratory productivity.
With millions of tests conducted monthly on cobas systems worldwide, the integration of MPX-E into existing infrastructure ensures rapid adoption and scalability across healthcare systems. This is particularly important in regions where blood safety and infectious disease control remain critical challenges.
By combining advanced molecular technology, automation, and multi-target detection, Roche is enabling healthcare providers to deliver safer blood products and more reliable diagnostic results, ultimately improving patient care and reducing the risk of transfusion-transmitted infections.
The introduction of the cobas MPX-E assay represents a major step forward in blood donor screening and infectious disease diagnostics, offering a comprehensive, efficient, and scalable solution for modern laboratories. With its ability to simultaneously detect multiple high-risk pathogens, enhance workflow efficiency, and improve diagnostic accuracy, the assay is poised to play a crucial role in strengthening global healthcare systems and ensuring patient safety.
Source: Roche press release
