SBIR Phase II: CoagCare-A POC Blood Coagulation Diagnostic Platform That Utilizes A Hand-held Meter and Mechanically Sensitive Test Strips for Broad Spectrum Hemostasis Monitoring

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to develop and commercialize a new technology for accurate, portable, and inexpensive measurement of multiple blood clotting parameters. Common tests are routinely performed on patients who suffer from conditions like atrial fibrillation, deep vein thrombosis, or have had heart valve replacement. These conditions affect millions of patients in the US alone and represent $2 B of spending annually. However, many current solutions cannot accurately or conveniently perform multiple blood clotting tests on the same system or sample, causing clinically significant problems for end-users and raising the cost and inconvenience of performing these tests routinely. The technology in this project will enable various blood clotting tests to be performed in a single portable system. This will potentially lead to cheaper and more convenient blood coagulation testing for medical professionals and improve medical outcomes by bringing accurate and multiple tests to a single portable devices. This Small Business Innovation Research (SBIR) Phase II project will develop a technology that will enable the first-of-its-kind implementation of a point of care (POC) direct, mechanical test in a meter and single-use disposable card format, to more closely replicate the mechanical methods that underpin blood clotting tests in the clinical laboratory. As a mechanical measurement, the card will measure physical properties of a clotting whole blood sample and account for confounding factors, such as hematocrit. Specifically, the objective of the project will be to develop a POC, hand-held, battery-operated system that can enable the generation of a viscoelastic curve and associated thromboelastography parameters in less than 10 minutes, a significant improvement over current bulky and labor-intensive solutions with turnaround times of up to 30 minutes or more. Beyond addressing the thromboelastography needs, the proposed broad-spectrum portable hemostasis platform can be extended to other coagulation tests based on fluid mechanical characterization of a blood sample, including prothrombin time, partial thromboplastin time, and activated clotting time. This project will demonstrate the implementation of a blood coagulation test in a portable POC system. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.