Skip to main content

Luminex Receives FDA Clearance, CE-IVD Mark for Aries M1 System

NEW YORK (GenomeWeb) – Molecular diagnostics developer Luminex announced today that it has received clearance from the US Food and Drug Administration as well as CE-IVD marking for its in vitro diagnostic system, the Aries M1.

The M1 is a lower-throughout version of the company's Aries System, and is designed for use in smaller satellite labs. It extracts, amplifies, and detects nucleic acid targets from a variety of sample types, and can process up to six different samples and up to six PCR-based 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," said President and CEO Homi Shamir in a statement. "Luminex now has the broadest offering of low-plex and high-plex sample-to-answer systems for clinical laboratories performing molecular diagnostic testing."

Luminex received 510(k) clearance from the FDA for the Aries System and Aries Herpes Simplex Virus (HSV) 1&2 Assay in October 2015, and CE-IVD marking for the system and assay in March. In June, it also received CE-IVD marking for its Aries Flu A/B & RSV assay, and has submitted it for FDA clearance as well.