VerOFy: A New Tool to Improve Productivity and Reduce Costs for Stress Research

DESCRIPTION (provided by applicant): This Phase 1 NIH SBIR proposal is for support of an interdisciplinary program involving the Oasis Diagnostics(R) Corporation, Madison Biodiagnostics, LLC, and the University of New Orleans who seek to collaboratively demonstrate an innovative saliva collection and analysis system (VerOFy(R)) for measurement of cortisol levels at the point of sampling for measurement of real time stress response in the clinical laboratory. The innovative VerOFy(R) Rapid, Oral Fluid TestPlatform (US PN 7,618,591) is an integrated sample collection and laboratory processing system that collects saliva by means of a proprietary absorbent pad connected to immunochromatographic test strips that produce a series of signal lines on the test strips correlating with varying cortisol levels in the acquired saliva sample within minutes of sample collection. Stress related research burgeoned to 22 million funded by NIH per year. Substantial research advancements were made after the stress hormone cortisol could be noninvasively measured in saliva. Salivary cortisol is arguably the most common biomarker used in a broad range of research protocols targeted at stress related illnesses. The present proposal pursues a significant advancement in stress research with the potential for advancing the field much like saliva testing did. Real time point of care cortisol measurement capability using the VerOFy(R) technology represents a substantial productivity improvement and cost reduction for stress responsiveness research. We estimate that between 30% and 50% of the 22 million expended for this research each year by NIH may produce little or questionable research benefit in current practice and would be potentially saved by use of the VerOFy(R) device. VerOFy(R) opens up new, unexplored possibilities within the stress research and related fields to tailor or individualize protocols for each individual including the rapid determination of stress non-responders. It further represents an opportunity for a standardized approach to cortisol measurements in stress related research. The cost and time benefits of this innovation will extend to 22 million of NIH funded research programs which rely upon the measurement of cortisol levels to identify stress responsiveness, bringing substantial cost reductions and productivity improvements to NIH funded stress related research. Phase 1 will demonstrate validation of the VerOFy(R) technology against standard control solutions of cortisol. Phase 2 of this program will demonstrate the effectiveness of this new method in improving research results and lowering the costs of stress related research. PUBLIC HEALTH RELEVANCE: NIH funds 22 million of stress related research which is dependent upon measurement of the biomarker cortisol as an indicator of stress response. Variation in current cortisol detection methods makes it impossible to individualize experimental protocols and compare results from different research programs. The present proposal uses an innovative salivary diagnostic device (VerOFy(R)) to standardize cortisol measurements and to lower stress related research costs.