Igen International Inc announced that its proprietary test for the diagnosis of venous thromboembolic (VTE) disease, commonly known as blood clots, will be used in an ongoing multi-center clinical trial sponsored by Canadian Institutes of Health Research (CIHR). The study will test for the presence of urinary fibrinopeptide B (FPB) as a marker for active VTE, as well as a tool to monitor the effectiveness of anti-coagulant therapy. Preliminary studies and data have confirmed that urine FPB levels can be used to screen patients with suspected VTE and to monitor patients following treatment.

The Company has exclusive commercialization rights for clinical tests utilizing urine- and blood-based FPB for the diagnosis of all diseases including VTE, which encompasses such conditions as deep vein thrombosis (DVT) and pulmonary embolism. It is currently estimated that as many as 600,000 cases of DVT and pulmonary embolism occur in the United States each year with fewer than half of these cases ever being diagnosed and treated. About 100,000 to 200,000 people die from pulmonary embolisms each year in the United States and approximately 80% of these fatal cases go undiagnosed. The Company estimates that the market potential in the United States for an approved VTE diagnostic could be as large as $200 million annually.

The CIHR study will involve over 2000 patients, of which more than 500 have already been enrolled, at five centers including the University of California, San Diego and four Canadian centers. This study was designed to advance the promising results of recently completed preclinical studies conducted by 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. Dr. Morris is a principal investigator for this study and the Company has been sponsoring his research efforts involving an Origen based FPB diagnostic for VTE disease.

Deep vein thrombosis occurs when a blood clot forms in the veins of the leg, and pulmonary embolism results when such a clot dislodges and blocks blood flow through the lungs, leading to respiratory distress. Risk factors for VTE disease include: sluggish blood flow resulting from immobility (e.g., bed rest or extended periods of sitting), obesity, congestive heart failure and/or venous obstruction; trauma (e.g., surgery and childbirth); advancing age; diabetes; cancer; and inherited deficiencies in natural anticoagulant proteins. Since symptoms associated with pulmonary embolism, such as chest pain and shortness of breath, are not specific to the disorder, it is often not diagnosed.

A sensitive and specific urine- or blood-based test for diagnosing both DVT and pulmonary embolism offer significant advantages for use in integrated health care over existing non-invasive tests for VTE disease, which lack the ability to detect active thrombosis and have limited clinical specificity. The current standards for diagnosing VTE disease, venous and arterial imaging, are expensive and invasive procedures that require the injection of potentially harmful dyes. Some of the potential applications of a blood- or urine-based test for VTE disease management would be the screening of high- risk patients, early disease detection, and the monitoring of patients who have already been diagnosed with VTE disease and are receiving anticoagulant therapy.