Luminex Corporation Submits FDA 510(k) Submissions for ARIES™ System and ARIES™ HSV 1&2 Assay
AUSTIN, Texas, July 14, 2015 /PRNewswire/ -- 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: http://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 http://www.luminexcorp.com/.
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward- looking statements in this release include statements regarding the development and testing progress of our pipeline products, including ARIES and related assays, and the regulatory approvals thereof. The words "believe", "expect", "intend", "anticipates", "confident", "will", "could", "should", and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, our ability to launch products on time, the timing of regulatory approvals, the outcome of clinical trials as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Contacts:
Luminex Investor Contact
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO
[email protected]
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing
[email protected]
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SOURCE Luminex Corporation
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