Austin, Texas-based Luminex Corporation is initiating clinical and analytical trials focused on their ARIES System and ARIES HSV 1&2 Assay, a sample method created to improve laboratory performance, efficiency and environment through error reduction. Luminex expects to submit the product to both the U.S. Food and Drug Administration (FDA) and the European authorities sometime this year.
Luminex announced in a press release it was beginning a series of ARIES studies in several clinical laboratories throughout the United States. ARIES was designed to minimize errors from lab operators using internal bar code scanning, as well as other advanced methods. In vitro diagnostics (IVD) and Laboratory Developed Tests (LDTs) work at the same time using a common Universal Assay Protocol, while an integrated PC eliminates the requirement to use a separate computer, stand-alone keyboard or mouse.
“We are excited to announce the start of ARIES clinical trials as planned, which represents a key milestone in our commercial launch schedule,” stated the president and CEO of Luminex, Homi Shamir. “Because we designed ARIES to be an easy to use solution that solves many of the problems and challenges laboratories face each day, we are highly optimistic in the market potential for this innovative platform. We continue to advance along our projected launch schedule, and expect to initiate clinical trials for additional ARIES assays in the coming months. With ARIES, we are solidifying a platform which we expect will accelerate growth for years to come,” added Shamir, noting that the company is planning to submit ARIES to the FDA this summer.
The company is focused on providing novel solutions to enhance health and advance science, using its xMAP open-architecture multi-analyte platform, MultiCode real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, which are expected to reduce costs and improve research outcomes of companies working on clinical diagnostic, pharmaceutical drug development, biomedical research or personalized medicine.
Luminex has presented the ARIES system for the first time to test infectious diseases during the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), which took place in Barcelona, Spain, from May 10-13, 2014. At the time, Luminex said that the system boasts a “scalable throughput, easy to use design, and networked data management software will deliver rapid results with a simple workflow.” The system’s launch featured 5 assays: the Flu A/B and RSV, HSV 1&2, Norovirus and Clostridium difficile (C. diff).