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Dade Behring Receives FDA Clearance for Use of Its Stratus(R) CS Acute Care(TM) D-Dimer Assay As an Aid in the Diagnosis of Venous Thromboembolism (VTE) (Deep Vein Thrombosis or Pulmonary Embolism)

Posted on: Wednesday, 28 September 2005, 18:00 CDT

Dade Behring (NASDAQ:DADE) has received clearance from the U.S. Food and Drug Administration (FDA) for the use of its Stratus(R) CS Acute Care(TM) 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 this method on the Dade Behring Stratus(R) CS System.

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 Dade Behring's Stratus(R) CS Acute Care(TM) D-dimer assay, aids in the diagnosis of VTE.

According to the American Public Health Association, VTE is the number one cause of unexpected hospital death and fatal PE may be the most common preventable cause of hospital deaths(5). PE is the third most common cause of death in the U.S. with at least 650,000 cases occurring annually(6).

"The ability to use the D-dimer test as an aid in the diagnosis of VTE, DVT or PE provides another significant offering to hospital laboratories worldwide," said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. "Receiving FDA clearance for the 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, as an aid in the diagnosis of venous thromboembolism (DVT or PE)."

With 2004 revenues of nearly $1.6 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_Facts and_Figures_2001-2002 (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). Accessed January 31, 2002.

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

5. American Public Health Association. Deep Vein Thrombosis: Advancing Awareness to Protect Patient Lives. February 26, 2003.

6. Feied C, et al. Pulmonary embolism. Available at: http://www.emedicine.com/EMERG/topic490.htm.

Source: Business Wire

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