D-dimer assay for Siemens Stratus CS Acute Care Diagnostic System is the only test available in U.S. with clinically-validated PE exclusion claim in the point-of-care setting
Tarrytown, NY, July 18, 2011 – The Siemens Healthcare Diagnostics D-dimer assay for the company’s Stratus® CS Acute Care™ Diagnostic System has been cleared by the FDA to exclude pulmonary embolism (PE) in conjunction with a non-high clinical pretest probability (PTP) assessment model in point of care. Currently, this is the only assay available in the U.S. to achieve this clinical validity for use in the point-of-care setting.
Studies show that elevated D-dimer levels, which are indicative of reactive fibrinolysis,1 correlate with a variety of clinical conditions, including pulmonary embolism.2 PE results when a blood clot from another part of the body, such as the arms or legs, breaks loose (embolizes) and travels through the blood stream to the lungs, where it can block the pulmonary artery. It is estimated that about half a million people develop an acute pulmonary embolism in the U.S. each year, and when left untreated, PE can be fatal. Unfortunately, diagnosing PE can be challenging, as symptoms are non-specific and vary from person to person.
The expanded use of the Stratus CS system D-dimer test to quickly exclude PE helps physicians at the point of care provide a more timely assessment in acute situations. Combining a sensitivity of 97 percent and an even higher negative predictive value (NPV) of 98 percent with the proven precision and speed of the Stratus CS system allows clinicians to have greater confidence, translating to better patient management. Further, results are available in as little as 14 minutes, and testing can be run on the same tube as other Stratus assays, eliminating the need to collect additional tubes or split samples.
“Clinicians in acute care are challenged to make timely decisions that can literally mean the difference between life and death for their patients,” said David Stein, Ph.D., CEO, Point of Care Business Unit, Siemens Healthcare Diagnostics. “Siemens is excited to be the first company to offer a test for PE exclusion at the point of care to help these physicians obtain the fast, accurate results that they need to guide critical clinical decision-making.”
Earlier this year, Siemens received FDA clearance for PE and deep venous thrombosis (DVT) exclusion claims for its INNOVANCE® D-dimer blood test, demonstrating the company’s continuing commitment to advancing diagnostic solutions.
The Stratus CS analyzer provides quantitative assays for fast, cost-effective evaluation. In addition to the D-dimer PE exclusion claim, the Stratus CS system offers a comprehensive assay menu that covers the spectrum of acute care assays. More information about the Stratus CS system can be found at: www.siemens.com/stratus.
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Budzynski AZ, et al. Blood. 1979; 54: 794.
- Graaf FVD, et al. Exclusion of Deep Vein Thrombosis with D-Dimer Testing. Thrombosis and Haemostasis 2000; 83:191-198.
The Siemens Healthcare Sector is one of the world’s largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 48,000 employees worldwide and operates around the world. In fiscal year 2010 (to September 30), the Sector posted revenue of 12.4 billion euros and profit of around 750 million euros. For further information please visit: www.siemens.com/healthcare
Contact: Susan Drew
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