Luminex Corporation Receives CE-IVD Mark for ARIES® Norovirus Assay

AUSTIN, Texas, June 28, 2017 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that it has received CE-IVD marking for the ARIES^® Norovirus Assay, an easy to use, sample to answer test for rapid detection and differentiation of norovirus genogroup I and II from stool specimens of individuals with symptoms of acute gastroenteritis.

The CDC reports that norovirus is estimated to be the most common cause of acute gastroenteritis worldwide, and each year, norovirus causes over 200,000 deaths and a global economic burden of more than $60 billion.¹

As the fifth CE-marked assay for use on Luminex’s ARIES^® Systems, the Norovirus Assay adds to a growing menu of tests for the ARIES^® platform. The 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.

“We are very excited to add the simple and cost-effective Norovirus Assay to our expanding menu of assays for ARIES^®,” said Thomas Pracht, managing director of Luminex Europe. “The ARIES^® Norovirus Assay offers excellent performance for high confidence in results and reduced hands-on time compared to other molecular assays. Further, by enabling rapid and accurate diagnosis even outside office hours, the assay can expedite appropriate infection control measures.”

ARIES^® Systems automate all aspects of testing, 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^® Norovirus 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^®C. difficile Assay (RUO).

The ARIES^® Norovirus Assay is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The assay also aids in the detection and identification of norovirus infections in the context of outbreaks. For more information, please visit www.luminexcorp.com/norovirus

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, please 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.

References:

Lopman BA, Steele D, Kirkwood CD, Parashar UD (2016) The Vast and Varied Global Burden of Norovirus: Prospects for Prevention and Control. PLoS Med 13(4): e1001999. https://doi.org/10.1371/journal.pmed.1001999

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

The ARIES® Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the identification and differentiation of norovirus genogroup I (GI) and genogroup II (GII) RNA.