This Phase II SBIR builds upon the activities of R43-AT006634, "VerOFy: A New Tool to Improve Productivity and Reduce Costs for Stress Research". Technology for an integrated sample collection system was developed which non-invasively measures salivary cortisol levels within minutes of sample collection;this is a substantial improvement over traditional immunoassays in which cortisol concentrations are not returned for days to months. This innovation is expected to have a large impact on stress research as cortisol changes frequently and critical information about stress is lost during this measurement specific time-delay. VerOFy(R) is also innovative as it decreases costs compared to traditional protocols which require samples to be assayed regardless of their utility. Thus, real-time point-of-care cortisol measurement using the VerOFy(R) technology represents a substantial productivity improvement and major cost reduction for stress research. Phase I activities were accomplished well within the allotted Project timeframe. Furthermore, the technology was advanced substantially beyond initial goals by testing the system with pilot samples from human participants and developing the technology into a fully quantitative format capable of measuring salivary cortisol in real-time in conjunction with a complementary innovation for signal line analysis, known as the Lightbox Image Analysis Module (LIAMTM) portable reader. These added activities were pursued in order to comprehensively respond to Phase I critiques. Proposed Phase II activities extend these activities substantially further by (1 finalizing quality control of the VerOFy(R) device (e.g., determining recovery, sensitivity, precision, etc);(2) validating the LIAMTM reader for real-time quantitative cortisol results by streamlining the reader process and exploring user-friendly technological advances with a smartphone application;and (3) validating both the VerOFy(R) and LIAMTM with human participants in an established setting as well as six beta-sites strategically selected to represen each region of the US and cover a range of expertise for product evaluation. In parallel to these research activities, a detailed commercialization plan is described in which this technology can be feasibly marketed, building from the prior experience of the investigative team and advisory board of researchers and relevant experts. By the end of phase II, the goal is to have a fully operational VerOFy(R) device to allow stress researchers to individualize protocols for each individual and rapidly determine stress responsively via salivary cortisol. Future directions illustrate plans to move the technology forward beyond the Research Use Only application, as the team has accomplished with prior technology. VerOFy(R) opens up new, unexplored possibilities within the stress field. The impact of this technology can be tremendous as the annual economic toll of stress-related illnesses and health problems exceed $200 billion in the US and the NIH funded $83 million of stress-related research which utilizes salivary cortisol already in 2012 alone.
NIH funds millions of stress-related research which relies on the biomarker cortisol as an indicator of stress responsivity and health risk. Current cortisol detection methods makes it impossible to individualize experimental protocols or provide feedback to the participant or researcher as cortisol assay results are not obtained for days to months. The present proposal uses an innovative salivary diagnostic device and reader to quantitatively measure salivary cortisol in real-time and lower stress-related research costs.