AUSTIN, Texas, July 19, 2011 /PRNewswire/ -- Luminex Corporation
(Nasdaq: LMNX) announced today that it has received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) for its
xTAG Respiratory Viral Panel FAST (RVP FAST). This front line test
has the potential to significantly change the way respiratory viral
testing is performed and complements the company's existing
respiratory portfolio.
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Laboratories and healthcare providers are looking for ways to
improve efficiency while managing increasingly complex disease
states. The value of multiplexed testing for respiratory viruses is
well established with Luminex as the market leader in providing
comprehensive multiplexed testing for respiratory viruses. The
addition of xTAG RVP FAST assay to Luminex's RVP growing product
portfolio brings additional testing options to diagnostic
laboratories looking for a front line assay targeting eight
essential respiratory pathogens and delivering up to 96 patient
results in a few hours.
"Providing faster results from a broad panel makes it easier for
physicians to quickly identify appropriate treatment. Better
patient outcomes have the potential to reduce hospitalizations and
the associated burden on the healthcare system," said Rodney Arcenas, Ph.D., Clinical Scientist,
Molecular Microbiology and Immunology for Memorial Healthcare
System in Hollywood, Florida.
"A streamlined and scalable assay that produces results in
shorter time is important in effectively managing fluctuating
patient volumes and seasonal spikes typically associated with
respiratory viral illnesses."
xTAG RVP FAST panel includes:
- Respiratory Syncytial Virus (RSV)
- Influenza A:
- Non-specific influenza A
- H1 subtype
- H3 subtype
- Influenza B
- Metapneumovirus (hMPV)
- Adenovirus
- Entero-Rhinovirus
With minimal hands-on-time from laboratory staff, xTAG RVP FAST
offers clinical and diagnostic laboratories the ability to rapidly
provide actionable patient results to physicians. In addition to
cost and time savings for the laboratory, earlier detection and
differentiation between viral and bacterial infections facilitate
appropriate physician treatment decisions, improving patient care
and helping to reduce healthcare costs.
"Clearance of xTAG RVP Fast allows us to provide clinical
laboratories with a new diagnostic tool to help manage their
patients with influenza-like illness," said Patrick Balthrop president and CEO of Luminex.
"Luminex is recognized for its leadership in the area of infectious
disease multiplexing assays, and particularly in respiratory viral
testing and we are pleased to provide a range of testing options
that meet our customers' needs and ultimately improve healthcare
for patients worldwide."
In addition to xTAG RVP FAST, Luminex's growing family of
molecular diagnostic products for infectious diseases include:
- xTAG RVP which received FDA approval in January 2008 as the first respiratory viral panel
testing for 12 viruses including H1N1 and was awarded the 2010 Prix
Galien Award for Best Medical Technology.
- xTAG Gastrointestinal Pathogen Panel (GPP) which
received CE mark approval in May 2011
and was recently used as a first-line screen in the management of
the E. coli outbreak in Europe.
- MultiCode-RTx Herpes Simplex Virus (HSV) 1&2, the
first FDA approved PCR-based qualitative test for detection and
typing of HSV-1 or HSV-2.
The xTAG RVP FAST panel is built on the versatile Luminex®
100/200™ platform that makes available a broad menu of applications
and will be commercially available from Abbott Molecular
Diagnostics and Fisher Healthcare.
More information will be available at the upcoming AACC meeting
in Atlanta at Luminex Booth #1645
or by contacting Luminex at 512.219.8020, or visiting
www.luminexcorp.com.
About Luminex Corporation
Luminex is committed to applying its passion for innovation to
advancing healthcare and research worldwide. We are
transforming global healthcare and life-science research through
the development, manufacturing, and marketing of proprietary
instruments and assays utilizing our xMAP open-architecture,
multi-analyte platform and our MultiCode real-time polymerase chain
reaction (PCR) and multiplex PCR-based technologies that deliver
cost-effective and rapid results to clinicians and researchers.
Our technology is commercially available worldwide and in use
in leading clinical laboratories as well as major pharmaceutical,
diagnostic, biotechnology and life-science companies. We are
meeting the needs of customers in markets as diverse as clinical
diagnostics, pharmaceutical drug discovery, biomedical research
including genomic and proteomic research, personalized medicine,
bio-defense research and food safety. For further information
on Luminex Corporation and the latest advances in multiplexing
using award winning technology please visit our website at
http://www.luminexcorp.com.
Contacts
Corporate:
Harriss T. Currie
Chief Financial Officer and Vice President, Finance
Luminex Corporation
hcurrie@luminexcorp.com
512.219.8020
Investors:
Matthew Scalo
Sr. Director, Investor Relations
Luminex Corporation
mscalo@luminexcorp.com
512.219.8020
Media:
Mimi Torrington
Director, Marketing Communications
Luminex Corporation
mtorrington@luminexcorp.com
512.219.8020
Leslie Denson
Porter Novelli
Leslie.Denson@porternovelli.com
512.241.2233
SOURCE Luminex Corporation