SBIR-STTR Award

BIOTHERM, Inc. proposes to design and develop a portable system, analogous to a handheld glucose meter, to permit rapid, convenient blood coagulation testing on freshly drawn samples from patients undergoing anticoagulant therapy. This cost-effective system would better help meet the needs of patients and provide for earlier release from hospitals. The use of such a system in the physician's office, in a free-standing ambulatory care facility, and in the home offers the potential for more rapid test turnaround time and consequently better control of therapy in patients with thromboembolic problems. During Phase I, a prototype reagent system together with an electronic measurement device will be fabricated, tested, and analyzed for feasibility. The system will be based on a sensitive coagulation monitoring technique.National Heart, Lung, and Blood Institute (NHLBI)

A phase I SBIR program has been completed to design and develop a prototyp system to permit convenient blood coagulation testing on freshly drawn samples from patients undergoing anticoagulant therapy. The study was based upon knowledge gained during the past two years with a sensitive monitoring system for blood coagulation reactions. A prototype reagent containing element together with an electronic measurement device was fabricated, tested, and analyzed for feasibility by Biotherm, Inc. This system has demonstrated the potential for rapid test turnaround time, greater convenience, and consequently better control of therapy in patient with thromboembolic disease. Further development during phase II will focus on: design and fabrication of preproduction prototypes; placement o these prototypes in clinical settings; acquisition of additional test data including data obtained by nonlaboratory trained personnel such as nurses; and evaluation of feasibility of use in hospital and physicians' office applications. Testing in clinical environments will be performed in conjunction with the North Carolina Memorial Hospital, University of North Carolina, Chapel Hill.

Thesaurus Terms:
Benzo-Alpha-Pyrones, Warfarin Biomedical Engineering, Instrumentation Clinically Oriented Biomedical Systems Automated, Computer Processing Of Clinical Data Biomedical Systems Automated, Patient Monitoring (Monitoring Devices) Blood And Re Disorders Chemotherapy Blood Coagulation, Anticoagulants Blood Coagulation, Fibrinolytic Agents Blood Coagulation Tests Blood Coagulation Tests, Prothrombin Time Blood (Hematologic) Tests Cardiovascular Disorders, Thrombosis Computer Programming Diagnostic Tests, Rapid Diagnosis Heart Disorders Chemotherapy, Fibrinolytic Therapy Human, Clinical Indicators And Reagents Optics, Colorimetry Optics, Light Scattering Polysaccharides, Glycosaminoglycans, Heparin Therapy Evaluation, HumanNational Heart, Lung and Blood Institute (NHLBI)