NEW YORK (GenomeWeb) – Luminex announced today that it has received medical device licenses from the Medical Devices Bureau of Health Canada's Therapeutic Products Directorate for the Aries System and Aries Herpes Simplex Virus (HSV) 1&2 Assay.
"We are excited to receive medical device licenses for the Aries System and the Aries HSV 1&2 Assay in Canada," Todd Bennett, vice president of global sales and customer operations, said in a statement. "We look forward to rapidly launching this revolutionary system there. We are confident that the Aries System will answer many of our Canadian clinical laboratory customers' needs by increasing efficiency, reducing errors, and delivering accurate and timely data to improve patient care."
The system and assay were cleared for use by the US Food and Drug Administration last October, and launched shortly thereafter. Luminex formally introduced it at the 2015 Association for Molecular Pathology annual meeting in Austin, Texas.
The real-time PCR-based sample-to-answer Aries system detects and amplifies nucleic acids. It uses cartridges, internal barcode scanning, and other features to minimize operator errors and has a built-in touchscreen computer to save benchtop space. At that time, the company said it planned to expand the Aries test menu, and had begun running clinical trials for Clostridium difficile and Group B Streptococcus assays.