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Luminex wins FDA and CE-IVD mark approval for Aries M1 in vitro diagnostic system

MDBR Staff Writer Published 07 July 2016

Luminex has secured clearance from the US Food and Drug Administration (FDA) and CE-IVD status for its new Aries M1 in vitro diagnostic system.

Aries

Suitable for lower throughput clinical labs, the new sample to answer system has been developed to carry out real-time PCR assays.

The new system includes the features of the firm's higher throughput Aries system, which extracts, amplifies and detects nucleic acid targets from a variety of sample types.

Results are generated without additional technical intervention, once the cassettes are loaded onto the instrument.

Aries system holds capacity to process up to six different samples, and one to six assays, at a time. It uses internal barcode scanning and other features to reduce operator errors.

The low throughput Aries M1 system includes one module that can run one to six different assays, according to the Aries universal assay protocol.

The higher throughput Aries system includes two independent modules, enabling to each support from one to six cassettes.

It allows for both STAT and Batch testing of IVD and homebrew assays using MultiCode reagents when using a universal assay protocol.

Luminex president and CEO Homi Shamir said: "In developing the Aries family of systems, we listened closely to the needs of our customers and crafted these products to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory.

"Luminex now has the broadest offering of low-plex and high-plex sample to answer systems for clinical laboratories performing molecular diagnostic testing."


Image: The Aries M1 system is designed to empower satellite clinical laboratories to take advantage of the same benefits as Luminex's higher throughput Aries system. Photo: courtesy of Luminex Corporation.