Luminex Corporation has announced that testing at the clinical trial sites for the ARIES® HSV 1&2 Assay is now complete. The next steps, including site to site reproducibility testing, followed by data analysis and assembly of the data package for submission to the FDA, are now underway. In addition, the company has commenced clinical and analytical studies to evaluate the ARIES Clostridium difficile (C. difficile) Assay.
"We are very pleased with the progress we are making on the ARIES launch schedule. The system has met all of our expectations during the clinical trials phase for the initial launch assay, allowing us to rapidly complete the testing at the trial sites for the HSV 1&2 Assay," said Homi Shamir, President and CEO of Luminex. "The start of clinical trials for the ARIES C. difficile Assay, the second assay in the ARIES pipeline, represents another milestone for Luminex. Given our progress to date, and our growing momentum, we are confident in our ability to maintain the current timelines for commercial launch of the ARIES platform scheduled for the fourth quarter of this year."
Luminex expects its FDA submission for the ARIES platform and ARIES HSV 1&2 Assay to occur in the summer of 2015. The clinical trials for the ARIES C. difficile Assay are being conducted at several clinical laboratories in the U.S.