Whole Blood Point of Care Metabolic Measurement - SB1

PROJECT SUMMARY Persons of all ages with certain metabolic disorders are at-risk for metabolic crises when a certain metabolite accumulates in the blood. While this metabolite can be measured in a clinical laboratory, currently there is no home-based device to monitor the metabolite that causes the metabolic crises. Patients, their caregivers, and the doctors who specialize in these metabolic disorders strongly believe that a home measurement device would enable significantly improved metabolite control and health outcomes. Through work in Phase II awards from the National Institutes of Health (R44HD107897) and the National Science Foundation (2111884), the company has developed demonstrably excellent technology that enables accurate measurement of the metabolite in a single drop of blood. This proposal is submitted as a Commercialization Readiness Pilot to perform late stage development and commercialization activities needed to overcome key software development, hardware manufacturing, and regulatory challenges necessary to bring the at home product to market.