Roche Launches cobas MPX-E Assay: Revolutionary 4-in-1 Blood Screening Test Enhances Global Blood Supply Safety
核心洞察
Roche has launched the cobas MPX-E assay (搜索), a groundbreaking 4-in-1 donor screening test that simultaneously detects HIV (搜索), Hepatitis C (搜索), B, and E viruses in a single workflow, now available in CE mark countries.
The new assay addresses a critical global health need, as Hepatitis E (搜索) alone accounts for an estimated 20 million infections and 70,000 deaths annually worldwide, with many carriers remaining asymptomatic.
The test runs on fully automated cobas x800 systems with up to 8 hours of walk-away time, offering laboratories faster turnaround times and cost-effective HEV (搜索) screening implementation without requiring additional instrumentation.
Roche announced the launch of its cobas MPX-E assay (搜索), a qualitative in-vitro test that represents a significant advancement in donor screening by consolidating the detection of four major viral targets into a single, efficient workflow. The test is now available in countries accepting the CE mark and simultaneously detects Human Immunodeficiency Virus (HIV (搜索) 1 and 2) and Hepatitis C (搜索), B, and E viruses.
"Safe, timely access to blood products is a cornerstone of modern healthcare," said Matt Sause, CEO of Roche Diagnostics. "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 Critical Global Health Needs
The cobas MPX-E assay (搜索) is designed to meet the evolving needs of modern laboratories and help prevent HEV (搜索) transmission through blood transfusions through increased sensitivity and specificity. Hepatitis E (搜索) (HEV) alone accounts for an estimated 20 million infections and 70,000 deaths annually worldwide. Because many carriers are asymptomatic, robust screening is the only way to manage risks to the blood supply.
The new test features dual-target detection for HIV-1 group M (搜索), targeting two independent regions of the viral genome to improve sensitivity and ensure reliable results even in the presence of mutations.
Technical Specifications and Laboratory Integration
The cobas MPX-E assay (搜索) is a multiplex real-time PCR test for the simultaneous detection and discrimination of HIV (搜索), HCV (搜索), HBV, and HEV (搜索) 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.
The assay runs on the fully automated cobas x800 systems (cobas 6800/8800 and cobas 5800), which are already used by laboratories worldwide to run more than 10 million tests per month. 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.
Operational Benefits and Market Impact
The assay offers flexible testing options, allowing laboratories to test for all four targets or select single targets based on their specific screening requirements. For laboratories currently screening for HEV (搜索), 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.
Nucleic Acid Testing (NAT) blood screening represents approximately 800 million CHF globally with an expected Compound Annual Growth Rate of +2% from 2024 to 2029. The cobas MPX-E test provides four critical results in a single test, increasing laboratory efficiency and decreasing healthcare costs while delivering faster turnaround times.