Austin-based Luminex, a biotechnology company that develops, manufactures and markets innovative biological testing technologies with applications throughout the diagnostic and life science industries, recently announced that it has submitted 510(k) applications to the US Food and Drug Administration for the company’s Aries platform and HSV 1 & 2 Assay.
The Ariex platform is designed as a cartridge-based, sample-to-answer diagnostic test that utilizes real-time PCR to analyze nucleic acid targets. Luminex is originally known for its xMAP® and xTAG® Technologies, which enable large numbers of biological tests to be conducted and analyzed quickly, cost-effectively and accurately. While Aries comes with a built-in touchscreen computer and has been found to produce a higher throughput than its predecessor platform, the xTag, it still cannot produce similar multiplexing.
“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.”
The company disclosed that it expects to receive the US FDA’s approval and CE-IVD marking before the end of the year. Clinical tests using Aries’ Clostridium difficile and Group B Streptococcus assays are already underway, and Luminex is intent on launching several more clinical trails for different assays by the end of 2015.
To learn more about what Luminex is working on, visit http://luminexcorp.com.
In a previous report on groundbreaking assays, the University of Texas MD Anderson Cancer Center at Houston and NanoString Technologies, Inc., a Seattle, Washington based publicly-held provider of life science tools for translational research and molecular diagnostic products, have announced a multi-year collaboration with the objective of accelerating the development and adoption of a new assay method based on NanoString’s nCounter Analysis System — an automated platform that uses a novel digital barcoding chemistry to deliver high-precision multiplexed assays across a number of important research applications.