SBIR Phase I: Development of a rapid, point-of-care coagulation test for the investigation and treatment of COVID-19-related coagulopathy.

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a rapid, point-of-care device that allows for the precision management of blood clotting (coagulation) disorders and therapies. The proposed technology will support the development of a fully-automated reader system, along with single-use disposable cartridges, to enable clinical testing of COVID-19 patients with blood clotting issues. Due to the severe inflammation that occurs during COVID-19 disease, these patients often require frequent testing for blood clotting disorders. The proposed technology will rapidly identify patients that are more likely to form blood clots, and it can help evaluate the effectiveness of their current regimens; this will have impact beyond the current pandemic.This Small Business Innovation Research (SBIR) Phase I project allows for the determination of coagulation factor-specific inhibition and/or deficiency and real-time monitoring of response to treatment. The development of a point-of-care, portable, small volume coagulation assay that can be used for anticoagulant management using a precision-medicine approach would enable the identification of coagulation factor-specific inhibition, and, therefore, prove to be an essential tool in the diagnosis and treatment of coagulation disorders. This diagnostic would also be able to be used in non-COVID-19 anticoagulant management, aiding the identification and quantification of anticoagulants in an emergency and surgical setting and in other high-risk patients, such as neonates.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.