Luminex secures FDA clearance and CE-IVD Mark for ARIES M1 System

6 July 2016 (Last Updated July 6th, 2016 18:30)

US-based medical technology company Luminex has secured US Food and Drug Administration (FDA) clearance and CE-IVD mark for its new in-vitro diagnostic system, the ARIES M1 System.

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US-based medical technology company Luminex has secured US Food and Drug Administration (FDA) clearance and CE-IVD mark for its new in-vitro diagnostic system, the ARIES M1 System.

The ARIES M1 System is a fully integrated, sample to answer platform designed to perform real-time PCR assays.

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.

"We are now adding another system based on customer feedback, and in doing so, expanding our market reach.

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

"And, with the acquisition of NSPH behind us, we can focus on continuing to move products in our pipeline towards commercialisation and realising the value in our newly acquired asset."

The ARIES M1 System replicates the functionalities of Luminex's higher throughput ARIES System, incorporated with features such as an intuitive system interface, STAT or batch testing, and true walkaway capability.

The device extracts, amplifies and detects nucleic acid targets from a variety of sample types.

The low throughput ARIES M1 System features one module to run one to six different assays according to the ARIES Universal Assay Protocol.

"The device extracts, amplifies and detects nucleic acid targets from a variety of sample types."

The higher throughput ARIES System provides two independent modules, each supporting one to six cassettes, allowing for both STAT and Batch testing of IVD and homebrew assays using MultiCode Reagents when using a universal assay protocol.

The device can be easily integrated into the modern laboratory infrastructure.

It uses an internal barcode scanner to minimise operator errors.

The system features an integrated touchscreen PC which eliminates the need for a separate computer, standalone keyboard, and mouse thereby saving space.


Image: ARIES M1 System. Photo: courtesy of PRNewsFoto / Luminex Corporation.