Luminex Corporation Submits FDA 510(k) Submissions for ARIES™ System and ARIES™ HSV 1&2 Assay
AUSTIN, Texas — Luminex Corporation (NASDAQ: LMNX) today announced that it has submitted 510(k) applications to the FDA for the company’s ARIES™ System and ARIES™ HSV 1&2 Assay. The company anticipates receiving FDA clearance and CE-IVD marking before the end of the year.
“The FDA submission for the ARIES platform represents the culmination of years of development work. In ARIES, we believe we have a truly differentiated product that will resonate quite favorably with laboratory customers,” said Homi Shamir, President and CEO of Luminex. “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.”
“We really like the ARIES System’s random batch design. ARIES is robust, flexible, with the right throughput. The ability to mix and match assays in the same run is a great fit for our workflow,” said Dr. Anami Patel, Technical Director of LeBonheur Children’s Hospital, an early access site for ARIES. “ARIES is very easy to operate and has some novel, attractive features in the software. In addition, the paperless reporting combined with the fast assay turnaround time makes ARIES a good solution to support our physicians by delivering high quality patient care.”
Clinical trials for the ARIES C. difficile Assay and the ARIES Group B Streptococcus (GBS) Assay are progressing, and the company expects to launch clinical trials for additional ARIES products prior to the end of the year.
About ARIES
ARIES is a sample to answer system designed to deliver superior laboratory performance, increase laboratory efficiency, and fit seamlessly into today’s lean laboratory environment. ARIES uses internal barcode scanning and other advanced features to minimize operator errors. Two independent magazine modules each support from one to six cassettes, allowing for both STAT and Batch testing. Simultaneous IVD and Laboratory Developed Tests (LDTs) can operate through a common Universal Assay Protocol. An integrated touch-screen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse; thus maximizing valuable bench space.
To learn more or request a demo, visit: https://www.luminexcorp.com/ARIES
About Luminex Corporation
Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex’s technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit https://www.luminexcorp.com/.

