Announcement • Mar 30
Roche Launches the Cobas MPX-E Assay, A New 4-In-1 Donor Screening Test Roche announced that the cobas MPX-E assay, a qualitative in-vitro test for the detection and discrimination of Human Immunodeficiency Virus (HIV 1 and 2) and Hepatitis C, B, and E viruses, is now available in countries accepting the CE mark. The cobas MPX-E test provides four critical results (for HIV, HCV, HBV, and HEV) in a single test, increasing laboratory efficiency and decreasing healthcare costs. The new test delivers faster turnaround times and allows labs to implement Hepatitis E (HEV) screening without requiring additional instrumentation. This assay is designed for use on the fully automated cobas x800 systems, enabling high-throughput screening with up to 8 hours of walk-away time. This new assay represents a significant advancement in donor screening by consolidating the detection of four major viral targets into a single, efficient workflow. By identifying these pathogens simultaneously, the cobas MPX-E assay helps laboratories streamline their operations while enhancing the safety of blood and blood products for patients. The cobas MPX-E assay is designed to meet the evolving needs of modern laboratories and, through increased sensitivity and specificity, help to prevent HEV transmission through blood transfusions. Hepatitis E (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. Additionally, the new test features dual-target detection for HIV-1 group M, targeting two independent regions of the viral genome to improve sensitivity and ensure reliable results even in the presence of mutations. Nucleic Acid Testing (NAT) blood screening is approximately CHF 800 million globally with an expected Compound Annual Growth Rate of 2% from 2024 to 2029. 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 cobas MPX-E assay is a multiplex real-time PCR test for the simultaneous detection and discrimination of HIV, HCV, HBV, and HEV 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 at the same time. The assay offers flexible testing options, allowing laboratories to test for all four targets or select single targets based on their specific screening requirements. 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. For laboratories currently screening for HEV, 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. Announcement • Mar 24
Roche Launches the Cobas Eplex Respiratory Pathogen Panel 3 Roche announced the launch of the cobas eplex respiratory pathogen panel 3 (RP3), a new diagnostic test designed to detect a broad spectrum of viruses and bacteria that cause respiratory illness. The new test detects up to 250 viruses and bacteria, including SARS-CoV-2, influenza, Bordetella pertussis, and RSV, in a single patient sample. Rapid results enable doctors to make fast, confident and critical treatment decisions that are vital for high-risk patients. Designed for the cobas eplex system, the test is easy to use and available around the clock, helping hospitals manage surges in respiratory cases. Differential diagnosis of respiratory infections can be complex because many of the viruses and bacteria associated with respiratory infections may cause very similar symptoms. For vulnerable populations, including the elderly, young children, and those with weakened immune systems, a respiratory infection can quickly become life-threatening. The cobas eplex RP3 panel provides critical support to healthcare providers during peak respiratory seasons, which are the most demanding times of the year. The new test detects more than 20 different viral and bacterial pathogens simultaneously. This helps clinicians quickly pinpoint the exact cause of a patient's illness, allowing them to start the right treatment sooner, implement adequate infection and transmission control measures, and, in some cases, avoid unnecessary antibiotic use and improve patient prognosis. With less than one minute of hands-on time required to start the test, it is incredibly easy for laboratory staff to use. With ease of use and fast time to results, the cobas eplex RP3 panel can help reduce the time patients spend in the emergency room and allows hospitals to better manage isolation beds, keeping infectious patients separate from others. The cobas eplex respiratory pathogen panel 3 is a qualitative in vitro diagnostic test aimed at the simultaneous detection and differentiation of up to 25 viral and bacterial targets. It runs on the cobas eplex system, a platform designed to simplify laboratory workflow with features like automated result reporting and external control tracking & monitoring. Like the RP2 panel, the RP3 panel detects common pathogens, such as influenza virus A and B, RSV, SARS-CoV-2, plus new pathogens including Bordetella parapertussis and Chlamydia pneumoniae that can cause severe illness in high risk patients. The cobas eplex RP3 panel also has updated inclusivity for influenza virus and SARS-CoV-2 to ensure coverage of current and recently circulating strains. This test is also the first in the cobas eplex family to feature flexible syndromic testing, giving the option to labs to customise up to 5 distinct panels based on local prevalence needs or unique patient presentations. 
