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Luminex's ARIES Norovirus Assay Receives CE-IVD Marking

Luminex Corporation has announced that it has received CE-IVD marking for the ARIES Norovirus Assay, an easy to use, sample to answer test for rapid detection and differentiation of norovirus genogroup I and II from stool specimens of individuals with symptoms of acute gastroenteritis.

The CDC reports that norovirus is estimated to be the most common cause of acute gastroenteritis worldwide, and each year, norovirus causes over 200,000 deaths and a global economic burden of more than $60 billion.

As the fifth CE-marked assay for use on Luminex's ARIES Systems, the Norovirus Assay adds to a growing menu of tests for the ARIES platform. The system is designed to run in multiple laboratory shifts and allows labs to simultaneously run both IVD and LDT assays in a sample to answer format when using a Universal Assay Protocol.

"We are very excited to add the simple and cost-effective Norovirus Assay to our expanding menu of assays for ARIES," said Thomas Pracht, managing director of Luminex Europe. "The ARIES Norovirus Assay offers excellent performance for high confidence in results and reduced hands-on time compared to other molecular assays. Further, by enabling rapid and accurate diagnosis even outside office hours, the assay can expedite appropriate infection control measures."

ARIES Systems automate all aspects of testing, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time while enabling easy implementation on weekends and night shifts. The ARIES Norovirus Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex's comprehensive gastroenterological testing menu that also includes the xTAG Gastrointestinal Pathogen Panel (GPP), VERIGENE Enteric Pathogens Test (EP), and the ARIES C. difficile Assay (RUO).

The ARIES Norovirus Assay is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The assay also aids in the detection and identification of norovirus infections in the context of outbreaks.

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