AUSTIN, Texas, April 27, 2015 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today 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.
About Clostridium difficile
C. difficile is a major cause of hospital-acquired diarrhea, often associated with antibiotic usage, elderly patients and those staying in long-term care facilities.1 This pathogen causes serious morbidity for nearly half a million Americans and kills 30,000 patients each year.2 Traditional immunoassays lack adequate sensitivity to detect cases, which can cause an infection control challenge and increased burden on hospital staff. Molecular diagnostic solutions allow hospital laboratories to quickly and accurately diagnose symptomatic patients.
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 support from one to six cassettes each, allowing for STAT and Batch testing. Simultaneous IVD and Laboratory Developed Tests (LDTs) operate through a common Universal Assay Protocol. An integrated 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 progress of our pipeline products, including ARIES and related assays and the regulatory approvals thereof. The words "believe", "expect", "intend", "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.
1. Prevent and Manage Infections Safely: C. difficile. Advancing Excellence in America's Nursing Homes (Internet). Cited 2015 April. Available from: https://www.nhqualitycampaign.org/files/AE_Factsheet_for_Leadership_Infections.pdf
2. C. diff infections. Centers for Disease Control and Prevention (Internet). Cited 2015 April. Available from: http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_infect.html
Luminex Investor Contact
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing
SOURCE Luminex Corporation