Luminex's new in vitro diagnostic system, ARIES M1 System receives US FDA clearance & CE-IVD Mark
Luminex Corporation 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.
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 today's 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.
The ARIES Systems are sample to answer molecular diagnostic platforms designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES uses internal barcode scanning and other advanced features to minimize operator errors. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space. The low throughput ARIES M1 System provides one module with the ability to run one to six different assays according to the ARIES Universal Assay Protocol. The higher throughput ARIES System provides two independent modules, each which support from 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.