Luminex Receives CE-IVD Mark for ARIES System and ARIES HSV 1&2 Assay
AUSTIN, Texas, March 21, 2016 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received CE-IVD marking for the ARIES® System and ARIES® HSV 1&2 Assay. The ARIES® System and ARIES® HSV 1&2 Assay previously received FDA clearance in October 2015 and were subsequently launched in the U.S. market.
"We are excited to have received a CE-IVD mark for the ARIES® System and ARIES® HSV 1&2 Assay and look forward to rapidly launching this revolutionary system in Europe," said Thomas Pracht, Managing Director, EMEIA, Luminex Corporation. "We believe that ARIES® will answer many of our clinical laboratory customers' needs to increase efficiency and reduce errors while delivering accurate and timely data to improve patient care."
About the ARIES® System and HSV 1&2 Assay
The ARIES® System is a sample to answer molecular diagnostic system 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. Two independent modules each support from one to six cassettes, allowing for both STAT and Batch testing of IVD and homebrew assays using MultiCode® Reagents when using a common Universal Assay Protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.
The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (rt-PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1&2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients, or in cerebrospinal fluid (CSF) from patients suspected of HSV infections of the central nervous system. The test is indicated for use with symptomatic individuals to aid in the diagnosis of HSV infections. The assay is not intended to be used for prenatal screening. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System.
About Herpes Simplex Virus 1 and 2 (HSV 1&2)
HSV-1 is a contagious infection, which is common and endemic throughout the world. The virus causes lifelong infection, and there is no cure, although treatment can reduce symptoms. It is mainly transmitted through oral-oral contact and causes "cold sores." HSV-2 infection is widespread and mainly sexually transmitted. It is estimated that up to 20 million people are newly infected with HSV-2 each year. HSV-2 causes genital herpes, characterized by the occasional appearance of painful genital ulcers. In addition, HSV 1&2 are common causes of viral meningitis and encephalitis, which are inflammation of the membranes surrounding the brain and spinal cord or brain, respectively. Prescription antivirals to treat herpes simplex include acyclovir, famciclovir, and valacyclovir. Serious complications occur most often in unborn babies, newborns, and people who have a long-term illness such as cancer or HIV/AIDS, or have a weakened immune system.
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 available market 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
cvalle@luminexcorp.com
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SOURCE Luminex Corporation
