NEW YORK (GenomeWeb) — Luminex announced yesterday that it has begun clinical and analytical studies of its Aries sample-to-answer molecular diagnostics system and associated herpes simplex virus (HSV) I and II assay, with plans to seek US and European approval for the products later this year.
Unveiled in late 2013, Aries is designed as a lower-throughput alternative to the company's higher-throughput infectious disease panels for use by clinical labs. Luminex had originally planned to launch the system in Europe in 2014 and in the US this year, and introduce assays for Clostridium difficile, HSV I and II, combined influenza A/influenza B/respiratory syncytial virus, norovirus, and group B Streptococcus.
In October, however, the firm disclosed that it had pushed back this timeline in order to conduct the clinical trials necessary to secure regulatory approvals.
"We continue to advance along our projected launch schedule, and expect to initiate clinical trials for additional Aries assays in the coming months," Luminex President and CEO Homi Shamir said in a statement.
Luminex said that the clinical studies are being conducted at several labs in the US and that it plans to submit the Aries system and the HSV assay to the US Food and Drug Administration this summer.