NEW YORK (GenomeWeb) – Luminex today announced that it has submitted 510(k) applications to the US Food and Drug Administration for the firm's Aries platform and HSV 1&2 Assay.
Aries is a cartridge-based, sample-to-answer system that uses real-time PCR for detection and quantification of nucleic acid targets. It offers higher throughput than the firm's earlier-generation xTag platform, but does not offer the same degree of multiplexing. The Aries platform also includes a built-in touchscreen computer.
"In Aries, we believe we have a truly differentiated product that will resonate quite favorably with laboratory customers," Luminex CEO Homi Shamir said in a statement. "As we near the commercial launch of the system, scheduled for later this year, we are excited to enter the next phase of the company's future, with an ever-increasing focus on the molecular diagnostics market, rapidly expanding the Aries menu and driving top-line revenue growth."
Luminex said it anticipates receiving FDA clearance and CE-IVD marking by the end of the year. Clinical trials for Aries Clostridium difficile and Group B Streptococcus assays are in progress and the firm expects to launch trials for more assays by the end of the year.