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