Luminex Corporation Receives U.S. FDA Clearance for New, Front Line Respiratory Viral Panel Test

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
[email protected]
512.219.8020

Investors:
Matthew Scalo
Sr. Director, Investor Relations
Luminex Corporation
[email protected]
512.219.8020

Media:
Mimi Torrington
Director, Marketing Communications
Luminex Corporation
[email protected]
512.219.8020

Leslie Denson
Porter Novelli
[email protected]
512.241.2233

SOURCE Luminex Corporation

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