Luminex Gets CE-IVD Mark for Its ARIES Flu A/B & RSV Assay

Luminex Corporation LMNX disclosed Wednesday that it received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices for the ARIES Flu A/B & RSV Assay. The company added that it was meant for use with the FDA cleared and CE-IVD marked ARIES System. The company indicated that the ARIES Flu A/B & RSV Assay was a rapid and accurate method for the detection and differentiation of three key respiratory pathogens. They were: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform. Luminex's MD for EMEIA, Thomas Pracht, commented, "The ARIES Flu A/B & RSV Assay provides a rapid, automated and cost-effective way to inform actionable treatment decisions and manage outbreaks in markets accepting CE marking for clinical use. Combined with our comprehensive respiratory test menu, we believe the ARIES® Flu A/B & RSV Assay provides the most flexible and complete clinical algorithm for improved patient outcomes." The company indicated that this was the second assay this year for which it was granted CE-IVD marking for use on the new ARIES System. The company added that it got CE-IVD marking for the ARIES HSV 1&2 Assay in March 2016, and FDA clearance in October 2015, along with clearance of the ARIES instrument system. On Wednesday, the stock traded 0.29 percent higher.