Luminex Receives CE-IVD Mark
News Jun 02, 2016
Luminex Corporation has announced that it has received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices for the ARIES® Flu A/B & RSV Assay. Designed for use with the FDA cleared and CE-IVD marked ARIES® System, the ARIES® Flu A/B & RSV Assay is a rapid and accurate method for the detection and differentiation of three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform.
The ARIES(R) Flu A/B & RSV Assay is a rapid, accurate method for the detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) from nasopharyngeal swab (NPS) specimens using the ARIES(R) System.
"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," said Thomas Pracht, Luminex's Managing Director for EMEIA. "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."
This is the second assay this year for which Luminex has received CE-IVD marking for use on the new ARIES® System. The company received 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.