Dade Behring Receives FDA Clearance for Use of Its Advanced D-Dimer As

    Business Editors

    DEERFIELD, Ill.--(BUSINESS WIRE)--Jan. 4, 2005--Dade Behring (NASDAQ:DADE) has received clearance from the U.S. Food and Drug Administration (FDA) for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (VTE), (deep vein thrombosis (DVT) or pulmonary embolism (PE)). The clearance included performance data with a defined cutoff value for the Dade Behring BCS(R) System and Sysmex(R) CA-1500 System. The assay is also for use on Dade Behring's BCT(R) System, and Sysmex(R) CA-7000 and CA-560 Systems.
    Venous thromboembolism is a serious medical condition, affecting millions of people worldwide every year. With DVT, a blood clot forms in the deep veins of the legs, pelvis or upper extremities, leading to either partially or completely blocked circulation. PE, which occurs when a clot breaks loose (embolizes) and travels to the lungs or pulmonary artery, causes more deaths annually in the U.S. than breast cancer, highway fatalities or AIDS (1-4).
    Symptoms of DVT and its related conditions can vary and may include leg pain and swelling, or, in the case of an embolism, difficulty and pain with breathing. However, in as many as 50 percent of instances of DVT, few or no symptoms are seen. Early diagnosis and treatment are essential. Utilization of pretest probability assessment, together with the Dade Behring Advanced D-Dimer assay, aids in the diagnosis of VTE.
    The Centers for Disease Control and Prevention, along with the American Public Health Association, have been conducting an education campaign to advance public awareness about venous thromboembolism, DVT and PE. The American Heart Association estimates that at least
    600,000 patients develop PE each year, and of these, some 60,000 die. Fatal pulmonary embolism may be the most common preventable cause of hospital death, according to the American College of Chest Physicians(5).
    "Every FDA clearance for a diagnostic test is an important step toward improving the quality of health care," said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. "Having this expanded use for this assay is extremely important to Dade Behring because it provides another important tool for physicians to utilize, along with pretest probability assessment, to aid in the diagnosis of venous thromboembolism (DVT or PE)."

    About Dade Behring

    With 2003 revenues of more than $1.4 billion, Dade Behring is the world's largest company dedicated solely to clinical diagnostics. It offers a wide range of products, systems and services designed to meet the day-to-day needs of labs, delivering innovative solutions to customers and enhancing the quality of life for patients. Additional company information is available on the internet at www.dadebehring.com.

    1. Silverstein M, Heit J, Mohr D, et al. Trends in the Incidence
    of Deep-Vein Thrombosis and Pulmonary Embolism: A 25-Year
    Population-Based Study. Arch Internal Med. 1998;158:585-593.

    2. National Highway and Traffic Safety Association. Fatality
    Analysis Reporting System (FARS) Web-Based Encyclopedia.
    Available at: http://www-fars.nhtsa.dot.gov. Accessed January
    31, 2002.

    3. American Cancer Society. Breast cancer facts and figures,
    2001-2002. Available at: http://www.cancer.org/eprise/main/docroot/stt/content/STT_1x_Breast_ Cancer_Factsand_Figures_2001-2002. Accessed January 31, 2002.

    (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)

    4. Centers for Disease Control Report. HIV/AIDS Surveillance
    Report 2001. Volume 13, Number 2.

    5. Hirsh J., Hoak J., Management of Deep Vein Thrombosis and
    Pulmonary Embolism. Circulation. 1996;93:2212-2245.

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CONTACT: Dade Behring Deirdra Dougherty, 302-631-6872

KEYWORD: ILLINOIS INDUSTRY KEYWORD: BANKING MEDICAL DEVICES SOURCE: Dade Behring

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