SBIR Phase I: 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/commercial impact of this SBIR Phase I project will commercialize a new technology for accurate, portable, and inexpensive measurement of blood clotting tests routinely performed on patients who suffer from conditions such as atrial fibrillation, deep vein thrombosis, or have a mechanical heart valve replacement. These conditions affect millions of patients in the US alone in an annual market worth more than $3 B worldwide. However, many of the state-of-practice technologies cannot accurately or conveniently perform multiple blood clotting tests on the same system, causing clinically significant problems for patients and raising the cost and inconvenience of routine testing. The technology in this project fundamentally enables these various blood clotting tests to be performed in a single portable, test-strip system. This will potentially lead to cheaper and more convenient blood clot testing for medical professionals and millions of patients; improve medical care by bringing accurate and multiple blood clotting tests to a single portable device; bring competition to devices which rely on older technologies; and foster small business and job growth in an emerging technology landscape that has the potential to address a 3 billion dollar, worldwide market. The proposed project will enable the first-of-its-kind implementation of a point of care (POC) direct, mechanical test in a meter and strip format, to more closely replicate the mechanical methods which fundamentally underlie all blood clotting tests in the clinical laboratory. As a mechanical measurement, the strip will measure physical properties of the clotting whole blood sample and account for the confounding factors affecting point of care blood clotting tests, such as hematocrit for prothrombin time / international normalized ratio measurement. As a broad-spectrum hemostasis platform technology, multiple blood coagulation tests can be brought to the portable point of care format, including thromboelastography (TEG), activated partial thromboplastin time (aPTT), activated clotting time (ACT), and prothrombin time / international normalized ratio (PT/INR) tests. This SBIR Phase I project will demonstrate the feasibility of a commercial blood coagulation test, realizing a mechanical, strip-based, portable POC blood coagulation platform 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.