New Test for Venus Thromboembolic Disease

An immunoassay has been developed to detect the presence of urinary fibrinopeptide B (FPB) as a marker for venous thromboembolic disease (VTE) and also to monitor the effectiveness of anticoagulant therapy.

The test offers advantages over existing noninvasive tests for VTE, which lack the ability to detect active thrombosis and have limited clinical specificity, says Igen International, Inc. (Gaithersburg, MD, USA), which developed the new test. Current methods include venous and arterial imaging, which are expensive and invasive procedures that require the injection of dyes. The new test is based on the Origen technology of Igen. Preliminary studies have confirmed that urine FPB levels can be used to screen patients with suspected VTE and to monitor treatment. VTE includes such conditions as deep vein thrombosis (DVT) and pulmonary embolism.

The immunoassay will be used to test patients for the presence of FPB in an ongoing multicenter clinical trial involving more than 2,000 patients, sponsored by the Canadian Institutes of Health Research (CIHR). The principal investigator is Dr. Timothy A. Morris, the inventor of the technology and an associate professor of pulmonary and critical care medicine at the University of California, San Diego, Medical School (UCSD, USA).

"The collaboration with UCSD has enabled us to address the prevalence of venous thromboembolism and its physiologic ramifications: DVT and pulmonary embolism,” noted Samuel J. Wohlstadter, chairman and CEO of Igen.





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