NEW YORK (GenomeWeb) – Luminex announced today that it has received CE-IVD marking for its Aries Flu A/B & RSV assay, clearing it for sale in Europe.
The assay runs on the Aries platform, a real-time PCR-based sample-to-answer system that detects and amplifies nucleic acids. It is designed to detect influenza A virus, influenza B virus, and respiratory syncytial virus nucleic acid from nasopharyngeal swabs specimens.
The assay is the second Aries test that has received European approval this year, following the CE marking of the Aries system and Herpes Simplex Virus (HSV) 1&2 assay in March. The Aries system and HSV assay were approved in the US in October 2015, and the flu and RSV assay was recently submitted to the US Food and Drug Administration.