Luminex Corporation Gets FDA Approval and CE-IVD Mark for Its ARIES M1 System

Luminex Corporation

revealed that it received FDA approval, as well as, CE-IVD marking for a fresh in vitro diagnostic system, the ARIES M1 System. According to the company, it was meant for lower throughput clinical labs. The company added that its ARIES M1 System was a fully integrated, sample to answer platform for performing real-time PCR assays. Luminex said that the System was designed to give power to satellite clinical laboratories to take advantage of the same benefits as its higher throughput ARIES System, with features like STAT or batch testing, an intuitive system interface, and true walkaway capability. The company added that the system detects, amplifies, and extracts nucleic acid targets from a different sample types. The system could process a maximum of six different samples. The company indicated that at a time, it could take up one to six assays. Once the cassettes were loaded onto the instrument, the company said that results could b generated without any more technical intervention. Luminex's President and CEO, Homi Shamir, commented, "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." He added that "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." Shares of the company fell 0.83 percent on Tuesday.