Luminex Receives FDA Clearance for Aries M1 System

Luminex Corporation has announced it has received FDA clearance and CE-IVD marking for a new in vitro diagnostic system, the ARIES® M1 System. Designed for lower throughput clinical labs, the ARIES® M1 System is a fully integrated, sample to answer platform for performing real-time PCR assays. ARIES(R) Systems are crafted to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into lean laboratory.

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, with features such as an intuitive system interface, STAT or batch testing, and true walkaway capability. The system extracts, amplifies and detects nucleic acid targets from a variety of sample types. Once the cassettes are loaded onto the instrument, results are generated without additional technical intervention.

The system can process up to six different samples, and one to six assays, at a time. "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 lean laboratory. We are now adding another system based on customer feedback, and in doing so, expanding our market reach," said Homi Shamir, President and Chief Executive Officer of Luminex.

"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 commercialization and realizing the value in our newly acquired asset." The new system will be on display at the upcoming AACC Annual Scientific Meeting & Clinical Lab Expo which is happening July 31–August 4 in Philadelphia, PA.