Luminex Corporation Receives U.S. Food and Drug Administration Clearance for xTAG(TM) Respiratory Viral Panel

  
    
  
  
    
      Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed 
      solutions, today announced that it has received 510(k) clearance from 
      the U.S. Food and Drug Administration (FDA) for its xTAG™ 
      Respiratory Viral Panel (RVP). xTAG RVP is the first 
      FDA-cleared assay to simultaneously detect and identify 12 viruses and 
      viral subtypes that together are responsible for more than 85 percent of 
      respiratory viral infections.
    
    
      xTAG RVP is a groundbreaking test that, with a single patient sample, 
      can assess the presence or absence of 12 viral targets and provide 
      qualitative results in a few hours. Traditional testing for this many 
      viruses requires multiple individual diagnostic tests to be performed on 
      a patient sample and can take several days to provide a thorough 
      diagnosis. The speed and reliability of xTAG RVP will help physicians 
      provide appropriate treatment, and prevent inappropriate antibiotic use 
      that has contributed to the creation of “superbugs.”
    
    
      With a non-invasive, painless swab, xTAG RVP tests for:
    
    
      
        Influenza A, influenza A-H1, influenza A-H3 and influenza B, which 
        cause the majority of flu cases in the U.S.;
      
      
        Adenovirus, which is responsible for approximately 10 percent of 
        respiratory infections and a subtype of which the Centers for Disease 
        Control (CDC) have recently identified as causing multiple deaths;
      
      
        Respiratory syncytial virus (RSV) A and B, the most common cause of 
        bronchiolitis and pneumonia in infants and children;
      
      
        Metapneumovirus, a recently-discovered virus that causes flu-like 
        symptoms and is thought to be the second leading cause of respiratory 
        infection in children;
      
      
        Parainfluenza 1, 2, and 3, which can cause upper or lower respiratory 
        infections in adults and children and, are thought to be responsible 
        for about half of croup cases and 10-15 percent of bronchiolitis and 
        bronchitis cases; and
      
      
        Rhinovirus, which causes the common cold.
      
    
    
      Created by Luminex Molecular Diagnostics in Toronto, and built on Luminex’s 
      flexible xMAP technology, xTAG RVP represents a number of “firsts.” 
      It is the first multiplexed nucleic acid test for respiratory viruses 
      cleared for in vitro diagnostic use by the FDA. It also is the first 
      test of any kind cleared to detect human metapneumovirus, the first test 
      cleared for influenza A subtyping, and the first molecular test cleared 
      for adenovirus.
    
    
      “Because the symptoms of respiratory disease 
      overlap tremendously, it can be very difficult to determine whether an 
      illness is caused by a virus, and if so, which specific virus, or 
      bacteria,” said Christine C. Ginocchio, 
      Ph.D., Director, Microbiology/Virology and Molecular Diagnostics at 
      North Shore-LIJ Health System Laboratories. “The 
      xTAG RVP provides results on a broad range of viral pathogens, which 
      will assist in the diagnosis of respiratory infections and help 
      physicians recommend the appropriate treatment quickly. The test also 
      tells us what types of viruses are circulating in our communities, which 
      can assist physicians and public health officials in preventing 
      outbreaks.”
    
    
      xTAG RVP’s unique ability to detect influenza 
      A subtypes H1 and H3 will allow it to play an important role in the 
      pandemic influenza monitoring plans of the U.S. Department of Health and 
      Human Services and the World Health Organization. The test will allow 
      public health officials to distinguish H1 and H3 subtypes, which 
      represent the vast majority of Influenza A subtypes, from rarer 
      subtypes. This way, the few samples that do test positive for Influenza 
      A but cannot be identified as H1 nor H3 subtypes can be flagged for 
      further investigation by the CDC or local public health labs.
    
    
      Luminex’s xTAG RVP is the 43rd 
      xMAP-based product to receive 510(k) clearance by the FDA. xMAP is a 
      multiplexing technology that can simultaneously deliver up to 100 
      individual tests within a single sample.
    
    
      “The approval of the Luminex xTAG RVP 
      is a critical milestone in the diagnosis, treatment and control of the 
      respiratory viruses that impact millions of individuals every year,” 
      said Patrick Balthrop, President and CEO of Luminex. “In 
      addition to helping improve the surveillance of viruses – 
      both in hospitals and community wide – this 
      test can significantly improve patient care. In a matter of hours, 
      rather than days, xTAG RVP can determine whether a patient has a 
      cold, the flu or another virus, allowing a doctor to prescribe an 
      effective treatment much more quickly.”
    
    
      Respiratory viruses are the cause of significant morbidity and mortality 
      in the U.S. each year:
    
    
      
        Respiratory viral infections are the 7th 
        leading cause of death in the United States, claiming the lives of 
        more than 60,000 annually.1
      
      
        Respiratory viruses are responsible for 75-80 percent of doctor visits.2
      
      
        Each year, up to 20 percent of U.S. residents get the flu. More than 
        200,000 people are hospitalized in the U.S. because of influenza and 
        36,000 die annually.3
      
      
        There are 66 million colds in the U.S. every year.4
      
      
        11 million adults and 5.3 million children (2.8 million under the age 
        of 5) are diagnosed with lower respiratory viral infections annually. 
        These viruses lead to the hospitalization of 208,000 adults and 
        430,000 children.5
      
    
    
      Respiratory viruses also are a major cause of lost time from work and 
      school, resulting in significant financial and social losses. Annual 
      direct and indirect costs of these viruses in the U.S. are estimated at 
      more than $10 billion.6
    
    
      Respiratory viruses are responsible for more than 80 percent of 
      respiratory infections.7 In many cases 
      antibiotics are prescribed to treat these viral infections. However, 
      antibiotics cannot change the course of illnesses caused by viruses. 
      With xTAG RVP, physicians will now have valuable information to help 
      them determine what their patients have and whether antibiotics are 
      needed. This test will assist in reducing the overuse of antibiotics, 
      which has contributed to the creation of antibiotic resistant bacteria 
      or superbugs.
    
    
      With FDA 510(k) clearance, xTAG RVP is now available for 
      diagnostic use in the U.S. and can be purchased through Luminex 
      Molecular Diagnostics and Fisher HealthCare, part of Thermo Fisher 
      Scientific Inc. (NYSE: TMO). xTAG RVP has received CE mark 
      certification, allowing Luminex to market the product in Europe.
    
    
      For more information on the xTAG RVP, please visit www.luminexcorp.com.
    
    
      Luminex will host a conference call to discuss xTAG RVP today, Thursday, 
      January 3, 2008, at 4:30 Eastern Time. The conference call will be 
      webcast live and will be accompanied by a slide presentation, both of 
      which may be accessed at http://www.luminexcorp.com. 
      Simply log on to the web at the address above, go to the Company section 
      and access the Investor Relations link. Please go to the website at 
      least 15 minutes prior to the call to register, download and install any 
      necessary audio/video software.
    
    
      About Luminex Corporation
    
    
      Luminex Corporation develops, manufactures and markets proprietary 
      biological testing technologies with applications throughout the 
      diagnostic and life sciences industries. The Company's xMAP® 
      multiplex solutions include an open-architecture, multi-analyte 
      technology platform that delivers fast, accurate and cost-effective 
      bioassay results to markets as diverse as pharmaceutical drug discovery, 
      clinical diagnostics and biomedical research, including the genomics and 
      proteomics research markets. The Company's xMAP technology is sold 
      worldwide and is already in use in leading clinical laboratories as well 
      as major pharmaceutical, diagnostic and biotechnology companies. Further 
      information on Luminex Corporation or xMAP technology can be obtained at 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. The words "believe," 
      "expect," "intend," "estimate," "anticipate," "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 or projected 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, market demand and acceptance of Luminex's products, the 
      Company's dependence on strategic partners for development, 
      commercialization and distribution of products, concentration of the 
      Company's revenue in a limited number of strategic partners, 
      fluctuations in quarterly results due to a lengthy and unpredictable 
      sales cycle and bulk purchases of consumables, Luminex's ability to 
      scale manufacturing operations and manage operating expenses, gross 
      margins and inventory levels, potential shortages of components, 
      competition, the timing of regulatory approvals, the implementation, 
      including any modification, of the Company's strategic operating plans, 
      risks and uncertainties associated with implementing our acquisition 
      strategy and the ability to integrate acquired companies, including Tm 
      Bioscience Corporation, or selected assets into our consolidated 
      business operations, including the ability to recognize the benefits of 
      our acquisitions, 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.
    
    
      1 Centers for Disease Control. About the Flu; 
      Influenza: The Disease. November, 2004. http://www.cdc.gov/flu/about/disease/htm. 
      Accessed June 2006.
    
    
      2 Hing E, Cherry DK, Woodwell DA. National 
      Ambulatory Medical Care Survey: 2004 Summary. Advance Data from Vital 
      and Health Statistics; No. 374. Hyattsville, Maryland: National Center 
      for Health Statistics. 2006.
    
    
      3 Centers for Disease Control. About the Flu; 
      Influenza: The Disease. November, 2004. http://www.cdc.gov/flu/about/disease/htm. 
      Accessed June 2006.
    
    
      4 National Center for Health Statistics data, 
      1994.
    
    
      5 National and regional estimates on hospital 
      use for all patients from the HCUP Nationwide Inpatient Sample (NIS); 
      The 2007 Infectious Disease Testing Market, the Venture Planning Group; 
      in-house calculations based on peer-reviewed literature.
    
    
      6 White House Government National Strategy for 
      Pandemic Influenza.
    
    
      7 Hodinka, R., 2005. William Beaumont Hospital’s 
      14th Annual Symposium on DNA Technology in the 
      Clinical Laboratory, “The Spread of 
      Respiratory Viruses.”