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Luminex Receives CE Mark for Aries Acute Gastroenteritis Assay

NEW YORK (GenomeWeb) – Luminex today said that it has received CE marking for the Aries Norovirus Assay, a sample-to-answer test for rapid detection and differentiation of norovirus genogroup I and II from stool specimens of people with symptoms of acute gastroenteritis.

The assay, a real-time PCR-based qualitative in vitro diagnostic test, is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information, Luminex said. It also aids in the detection and identification of norovirus infections in the context of outbreaks, the firm added.

Thomas Pracht, managing director of Luminex Europe, said in a statement that the assay provides "excellent performance for high confidence in results and reduced hands-on time compared to other molecular assays."

The Aries platform automates testing from sample preparation through analysis, providing answers in less than two hours. 

The norovirus assay is part of a Luminex gastroenterological testing menu that also includes the xTAGgastrointestinal pathogen panel, Verigene enteric pathogens test, and the research-use-only Aries C. difficile assay.

It's the fifth assay CE marked for use on Luminex's Aries system, which is designed to run in multiple laboratory shifts and enable labs to run both IVD and laboratory-developed assays.

Norovirus is among the most common causes of acute gastroenteritis, and is the source of more than 200,000 deaths each year, along with being a global economic burden of more than $60 billion, Luminex said, citing statistics from the Centers for Disease Control and Prevention.