SBIR-STTR Award

A number of clinical trials have recently demonstrated that anti-coagulant drugs such as Warfarin, are highly effective at preventing strokes and heart attacks in at-risk population groups. However, these drugs can cause uncontrolled bleeding and other undesirable side effects. Thus, frequent monitoring of blood coagulation rates by prothrombin time tests is required for safe treatment. This requires the patient to visit a clinic every few weeks for testing, at considerable expense and inconvenience. The availability of a simple, accurate, low cost home test would facilitate wider use of anti-coagulant treatments and potentially improve the standard of care for anti-coagulated patients. This project will explore technology that would enable such home tests. It is based on combining the technology of optically active Thrombin substrates (which enable simple prothrombin time tests) with the dry reagent technology commonly used to make low-cost strip/meter-based home blood glucose tests for diabetics. Thrombin substrates with the specificity and optical characteristics appropriate for these tests will be synthesized, and incorporated into prototype reagents. The properties of these reagents will be evaluated with a prototype meter. The performance characteristics of the system will be assessed in comparison studies with clinical materials from UCSF.Awardee's statement of the potential commercial applications of the research:This research has high commercial potential, as the market for this product includes several million cardiac patients with an estimated market size exceeding $500 million/year in the U.S.National Heart, Lung and Blood Institute (NHLBI)

A large number of clinical trials have demonstrated that anti-coagulant drugs, such as Warfarin, are highly effective at preventing strokes and heart attacks in at-risk population groups. However, these drugs can cause uncontrolled bleeding and other undesirable side effects. Thus, frequent monitoring of blood coagulation rates by prothrombin time tests is required for safe treatment. This requires the patient to visit a clinic every few weeks for testing, at considerable expense and inconvenience. The availability of a simple, accurate, low cost home test would facilitate wider use of anti-coagulant treatments and potentially improve the standard of care for anticoagulated patients. We will develop such a test by incorporating fluorescent thron bin substrate technology into a simple, dry reagent test strip to produce a low cost strip/meter system similar to the home blood glucose systems widely used by diabetics. This approach was successful, and working prototypes were produced. In phase II, the studies will continue, and focus on: optimization of the test strip and meter, scale-up issues, calibration, human factors studies, control solution development, and extensive clinical trials. The studies, together with Phase III studies, will be used to seek FDA certification of the system.Awardee's statement of the potential commercial applieations of the research:The research will lead to a physician prescribed, low cost home test for prothrombin time. These tests will be used to monitor patients on oral anticoagulant therapy. This should lower medical costs, and improve patient care.National Heart, Lung, and Blood Institute (NHLBI)