Triage® D-Dimer Test aids in assessment of PE and DVT.
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Triage® D-Dimer Test aids emergency physicians in assessment and evaluation of patients suspected of having thromboembolic events, including pulmonary embolism (PE) and deep vein thrombosis (DVT). Portable, point-of-care diagnostic test provides D-dimer results in ~15 min and can be used in emergency department or at patient's bedside. It uses immunoassay technology and 3B6 D-dimer antibody. Test is run on Triage MeterPlus.
Original Press Release:
Biosite(R) Incorporated Announces Availability of Triage(R) D-Dimer Test
SAN DIEGO, February 17 -- New Test Aids Emergency Physicians in Diagnosing Highly Lethal Conditions
Biosite(R) Incorporated (Nasdaq: BSTE), a research-based provider of novel, rapid medical diagnostics, today announced the launch of its new, rapid, quantitative Triage(R) D-Dimer Test, extending availability of the test to the United Kingdom, Ireland, Australia, New Zealand, Hong Kong, South Africa and the Caribbean. The Triage D-Dimer Test aids in the assessment and evaluation of patients suspected of having thromboembolic events, including pulmonary embolism (PE) and deep vein thrombosis (DVT), which are common and potentially lethal conditions. The test was recently launched in the United States.
Portable and easy-to-use, this point-of-care diagnostic test provides D-dimer results in approximately 15 minutes and can be used in the emergency department or at a patient's bedside. The test uses highly sensitive immunoassay technology and the highly specific 3B6 D-dimer antibody. (1)(2)(3) The Triage D-Dimer Test is run on the widely used Triage MeterPlus and correlates with other ELISA-based D-dimer tests.
"Pulmonary embolism is a time-critical and potentially life threatening condition. Because patients often present with vague symptoms, PE represents a clinical and diagnostic challenge," said Ken Buechler, Ph.D., Biosite's president and chief scientific officer. "We believe the Triage D-Dimer Test, used at the point-of-care, can help emergency department physicians rapidly evaluate patients suspected of having a thromboembolic event, which should result in better patient care."
In a recent single center study published in the "Annals of Emergency Medicine," a point-of-care clinical protocol for the evaluation of PE using a commercially available rapid whole-blood immunochromatographic test for D-dimer doubled the number of patients evaluated for PE and decreased length of stay in the emergency department, without increasing the need for vascular imaging.(4)
Currently, more cases of PE are missed than are actually diagnosed because of vague and non-specific symptoms. PE is the third most common cause of death in the United States, with at least 650,000 cases occurring annually. It is the first or second most common cause of unexpected death in most age groups. The highest incidence of recognized PE occurs in hospitalized patients. Autopsy results show as many as 60 percent of patients dying in the hospital have had a PE, but the diagnosis has been missed in about 70 percent of the cases(5).
In November 2003, Biosite signed an agreement with Brisbane-based biotechnology company Agenix Limited for a license to D-dimer technology and the commercial supply of the 3B6 D-dimer antibody.
About Biosite Incorporated
A leader in the drive to advance diagnosis, Biosite Incorporated is a research-based company dedicated to the discovery and development of novel protein-based diagnostics that improve a physician's ability to diagnose debilitating and life-threatening diseases. Through combined expertise in diagnostic discovery and commercialization, Biosite is able to access potential markers of disease, identify proteins with high diagnostic utility, develop and commercialize products and educate the medical community on new diagnostic approaches, thereby benefiting patients. Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of U.S. hospitals and in more than 50 international markets for toxicology screening and diagnosis of infectious and cardiovascular disease. Information on Biosite can be found at www.biosite.com.
Biosite(R), Triage(R) and New Dimensions in Diagnosis(R) are registered trademarks of Biosite Incorporated. The Company's logo is a trademark of Biosite Incorporated.
3B6 D-dimer The Essential Element(TM) is a trademark of AGEN(R) Biomedical LTD.
(1) Dempfle, C-E, Zips S, Ergul H, Heene D and the FACT Study Group, The Fibrin Assay Comparison Trial (FACT), J Thromb Haemost 2001: 85: 671-8.
(2) Stein and Hull et al, D-dimer for the Exclusion of Acute Venous Thrombosis and Pulmonary Embolism, Ann Intern Med. April 2004
(3) Philip S. Wells, Evaluation of D-dimer in the Diagnosis of Suspected Deep-Vein Thrombosis, NEJM, 2003
(4) J. Kline, et al. Ann Emerg Med. 2004; 44:490-502.
(5) Feied CF: Pulmonary embolism. In: Rosen and Barken, eds, Emergency Medicine Principles and Practice, 4th ed. 1998; 3: Chapter 111.
Web site: www.biosite.com
