Applications and Methods for Continuous Monitoring of Physiological Chemistry

Point of care (POC) diagnostic devices are a well established market but have significant growth opportunities. Stable off-the-shelf biological recognition elements available in a form that can be readily incorporated into POC devices will be essential for wide spread use and deployment. Other than glucose oxidase, stable active oxidase enzymes are not available. Pinnacle has developed intellectual property (patent PCT/US11/51193) that provides a general solution for the use of cofactors to maximize the activity of oxidase enzymes used in diagnostic devices. We have also discovered that fusion proteins can dramatically enhance the stability of oxidases without compromising catalytic activity. Using high throughput screening of fusion proteins, directed evolution and large scale protein production in E.coli, we are developing a platform methodology for the optimization of existing (e.g. histamine, lactate), and the creation of new (e.g.cortisol) oxidases. Pinnacle Technology manufactures, sells and warranties biosensors for the detection of glucose, glutamate, lactate, and alcohol in animals. With the Richter and Gao laboratories at the University of Kansas, we have successfully cloned, expressed, purified and characterized oxidases for biosensors. The enzymes produced will be available for direct sale, or as biosensors. World-wide total biosensor sales are expected to reach $14 billion by 2016.