US-based biotechnology company Luminex has secured CE-IVD mark approval for Aries system and Aries HSV 1&2 assay.
Both the units received approval from the US Food and Drug Administration last October, and are currently available in the US market.
Luminex EMEIA managing director Thomas Pracht said: "We are excited to have received a CE-IVD mark for the Aries system and Aries RIES HSV 1&2 assay and look forward to rapidly launching this revolutionary system in Europe.
"We believe that Aries will answer many of our clinical laboratory customers’ needs to increase efficiency and reduce errors while delivering accurate and timely data to improve patient care."
The Aries system is designed to increase laboratory efficiency and provide accurate results. It uses internal barcode scanning and other advanced features to reduce operator errors.
Two independent modules each support from one to six cassettes, helping in both Stat and Batch testing of IVD and homebrew assays.
They leverage multicode reagents when using a common universal assay protocol.
The Aries HSV 1&2 assay is a real-time polymerase chain reaction (rt-PCR) based qualitative in vitro diagnostic test, which is indicated for use with symptomatic individuals to assist in the HSV infections.
It was developed for the direct detection and typing of herpes simplex virus (HSV 1&2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients or in cerebrospinal fluid (CSF) from patients suspected of HSV infections of the central nervous system.
The company said that the assay is indicated for use on the Aries system.
Image: Aries is a sample to answer system crafted to increase laboratory efficiency and produce accurate results. Photo: courtesy of Luminex Corporation.