AUSTIN, Texas, June
1, 2016 /PRNewswire/ -- Luminex Corporation (NASDAQ:
LMNX) today announced that it has received CE-IVD status
under the European Directive on In Vitro Diagnostic Medical Devices
for the ARIES® Flu A/B & RSV Assay. Designed
for use with the FDA cleared and CE-IVD marked
ARIES® System, the ARIES® Flu A/B
& RSV Assay is a rapid and accurate method for the detection
and differentiation of three key respiratory pathogens: influenza A
virus, influenza B virus, and respiratory syncytial virus (RSV)
using a sample to answer platform.
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"The ARIES® Flu A/B & RSV Assay provides a rapid,
automated and cost-effective way to inform actionable treatment
decisions and manage outbreaks in markets accepting CE marking for
clinical use," said Thomas Pracht, Luminex's Managing Director
for EMEIA. "Combined with our comprehensive respiratory test menu,
we believe the ARIES® Flu A/B & RSV Assay provides
the most flexible and complete clinical algorithm for improved
patient outcomes."
This is the second assay this year for which Luminex has
received CE-IVD marking for use on the new ARIES®
System. The company received CE-IVD marking for the
ARIES® HSV 1&2 Assay in March 2016, and FDA clearance
in October 2015, along with clearance of the
ARIES® instrument system.
To learn more or request a demo, please
visit: http://www.luminexcorp.com/ARIES.
About the ARIES® System and Flu A/B
& RSV 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® Flu A/B & RSV Assay is a polymerase
chain reaction (PCR) based qualitative in vitro diagnostic test for
the direct detection and differentiation of influenza A virus,
influenza B virus, and respiratory syncytial virus (RSV) nucleic
acid from nasopharyngeal swabs (NPS) specimens from patients with
signs and symptoms of respiratory tract infection in conjunction
with clinical and laboratory findings.
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 technologies are 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:
Investor Contact
Harriss Currie,
512.219.8020
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing
cvalle@luminexcorp.com