Colorimetric Diagnostic Strip for Monitoring Weight-gain Metabolic Biomarker in Saliva

Guild BioSciences proposes to develop a self-contained, low-cost, disposable, easy to use, colorimetric test strip that enables soldiers to measure/monitor salivary Adiponectin protein, a unique biomarker whose decreased circulating level is an indicator of weight-gain metabolic processes. The proposed test strip requires no special training to operate and results can be visibly read within ten minutes. To ensure the sensitive detection of the salivary Adiponectin at ng/mL level, innovative strip architecture and in-situ signal amplification will be integrated into the test strip. Specific efforts in Phase I will be directed to characterize the nature of adiponectin in human saliva by multiple biochemical methods. The performance of the prototype strip will be evaluated by measuring the Adiponectin level of human saliva samples from a human specimen repository. In Phase II, we will optimize and validate the test strip, investigate the correlation of Adiponectin level in saliva and blood, determine the cult-off value by analyzing a large number of clinical saliva samples, and refine manufacturing processes in preparation of mass production and commercialization.