The cobas MPX-E assay is now available in CE-mark accepting countries, offering labs a scalable, automated solution for multiplex nucleic acid testing.
Roche has launched the cobas MPX-E assay, a qualitative in vitro test designed to simultaneously detect and discriminate human immunodeficiency virus (HIV 1 and 2) and Hepatitis C, B, and E viruses in a single workflow. The assay is now available in countries accepting the CE mark, consolidating four major viral targets into one screening process to help laboratories improve efficiency while safeguarding blood and blood product safety.
“Safe, timely access to blood products is a cornerstone of modern healthcare,” says Matt Sause, chief executive officer of Roche Diagnostics, in a release. “With the launch of the cobas MPX-E test, we will help ensure that patients receive the safe blood products they need by providing a fully integrated solution that includes the most critical viral pathogens and improves lab efficiency.”
Addressing the HEV Screening Gap
A key feature of the new assay is its inclusion of Hepatitis E virus (HEV) screening. HEV accounts for an estimated 20 million infections and 70,000 deaths annually worldwide, according to Roche. Because many carriers are asymptomatic, the company notes that robust screening remains the only reliable method for managing HEV risk in the blood supply.
For laboratories already screening for HEV, Roche says the cobas MPX-E assay offers faster turnaround times. For those looking to implement HEV screening for the first time, the assay is designed to do so without requiring additional floor space or instrumentation — an important consideration for labs operating under space and budget constraints.
Dual-Target HIV Detection and Flexible Testing Options
The cobas MPX-E assay also features dual-target detection for HIV-1 group M, targeting two independent regions of the viral genome. According to Roche, this approach is intended to improve sensitivity and ensure reliable results even in the presence of viral mutations — a persistent challenge in nucleic acid testing for HIV.
Laboratories can test for all four targets simultaneously or select individual targets based on their specific screening requirements, offering flexibility for operations with varied testing protocols. The ready-to-load reagents and automation support up to eight hours of walk-away time, allowing laboratory staff to focus on other critical tasks.
Runs on Existing cobas x800 Infrastructure
The assay is designed for use on the cobas x800 family of systems, including the cobas 6800/8800 and cobas 5800 platforms. Roche reports that these systems are already deployed in laboratories worldwide, collectively processing more than 10 million tests per month. The ability to run the cobas MPX-E assay on existing instrumentation may lower the barrier to adoption for labs looking to expand their donor screening capabilities without investing in new equipment.
A Growing Market for NAT Blood Screening
The launch comes as the global nucleic acid testing blood screening market continues to expand. According to data from the FY24 IQVIA Diagnostics market book cited by Roche, the market is valued at approximately 800 million CHF globally, with an expected compound annual growth rate of 2% from 2024 to 2029.
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