Luminex Grabs FDA Clearance for ARIES C. difficile Assay
Sample to answer test provides detection of both toxin A and B
AUSTIN, Texas, July 24, 2017 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES®C. difficile Assay, a moderate complexity, sample to answer test for rapid detection of C. difficile. The ARIES®C. difficile Assay detects both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce toxin A. This milestone continues the company's track record of a rapid succession of regulatory clearances for assays on the ARIES® Systems, such as Bordetella, GBS and Norovirus CE-IVD earlier this year.
The CDC has classified Clostridium difficile (C. difficile) as an 'Urgent' threat requiring more monitoring and prevention activities, in part because it has become the most common microbial cause of healthcare-associated infections in U.S. hospitals. A 2015 CDC study found that C. difficile caused almost half a million infections among patients in the United States in a single year. An estimated 15,000 annual deaths are directly attributable to C. difficile infections, making it a substantial cause of infectious disease death in the United States.
Dr. Ray Widen, Scientific Director, Esoteric Testing and R&D at Tampa General Hospital, commented: "C. difficile infections have become more frequent, severe and difficult to manage in recent years, increasing our need for better tools to diagnose and treat these debilitating and life threatening infections. This includes the ability to detect both toxin A and B genes of the bacterium. The ARIES®C. difficile Assay was easy to use and performed very well in our lab during the clinical trial. The combination of a simple workflow for ease of training, sample in/answer out capabilities for ease of use, rapid time to result, and flexible batch size, makes the ARIES® System a good fit for routine microbiology laboratories that may not have prior experience with molecular assays."
"With this regulatory approval, we are further broadening our infectious diseases testing portfolio and adding to our rapidly growing menu of targeted assays and customized panels," said Homi Shamir, President and Chief Executive Officer of Luminex. "We are very pleased to offer a new solution to hospitals and molecular testing labs that can help improve their ability to test for these serious infections. From GI to respiratory, blood culture to women's health, we are making a true difference in the delivery of healthcare with the rapid number of high quality products we are bringing to market, including four new tests for the ARIES® System already this year."
The ARIES® System is designed to run in multiple laboratory shifts and allows labs to simultaneously run both IVD and LDT assays in a sample to answer format when using a Universal Assay Protocol. All aspects of testing are automated, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time while enabling easy implementation on weekends and night shifts. The ARIES®C. difficile Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex's comprehensive gastroenterological testing menu that also includes the xTAG® Gastrointestinal Pathogen Panel (GPP), VERIGENE® Enteric Pathogens Test (EP), and the ARIES® Norovirus Assay CE-IVD.
About ARIES® Systems
ARIES® Systems are sample to answer molecular diagnostic systems designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES® uses internal barcode scanning and other advanced features to minimize operator errors. Independent modules support from one to six cassettes, allowing for both STAT and batch testing of IVD assays and laboratory developed tests (LDTs) with MultiCode® Reagents when using a universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.
To learn more or request a demo, visit: http://www.luminexcorp.com/ARIES
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at 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 available market and customer acceptance for ARIES®, future revenue growth anticipated for ARIES®, and the development, testing and regulatory approval progress of our pipeline products, including ARIES® related assays. 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
hcurrie@luminexcorp.com
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing Communications
cvalle@luminexcorp.com
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SOURCE Luminex Corporation
