SBIR-STTR Award

This phase I NIH SBIR proposal seeks support for an interdisciplinary partnership between Oasis Diagnostics® and Iowa State University who collaboratively seek to develop a novel tool that can measure and quantify levels of the sex hormone testosterone in saliva within minutes of collection: VerOFy® testosterone. The FDA has urged caution regarding clinical use of T replacement therapy, calling for more research and greater differentiation of clinical vs experimental application, noting that “low T” is often treated without being measured once or more frequently. We share this cautionary tone and designed VerOFy® testosterone to better understand how T works endogenously in the body and changes in response to situational context at the moment, at the point of care, and non-invasively using saliva specimens. Currently, it is impossible to uncover T changes until days to weeks later, which poses a critical barrier to research or monitoring applications. The present proposal targets T in order to make a strong impact on risky decision making research. Risky decisions, especially in young populations, impact on mental and physical health outcomes, such as drug initiation and abuse, risky sex, accidents and early mortality. The applications for POC T testing go well beyond the implications for decision making in the research community, and the true size of the market is much larger with applications in the fields of neurobiology, neuroendocrinology, psychobiology, gender development, professional sports teams, sports medicine, fitness, stress and wellness. Rapid, quantitative salivary T measurement may be convenient for novel applications on the physiology of competitive sports and performance enhancement. The commercial potential is estimated to be high based on a growing billion-dollar hormone testing industry and a burgeoning wellness market. The product to be developed is a rapid point-of-care, non-invasive Testosterone (T) assay. This technology, based upon the VerOFy® proprietary technology, is comprised of (a) the Super·Sal™ Extra Saliva Collection device, (b) the analyte-specific LFT cartridge and (c) the LIAM™ (Litebox Image Analysis Module) reading device with portability to mobile technologies. This builds from our prior success in developing VerOFy® cortisol which shows that this team can feasibly deliver SBIR-relevant results. No other commercial entity has created an LFIA point-of-care platform that provides immediate results for T from saliva. Quantitative T assessment in saliva at the POC is innovative in itself; we further propose innovations. We will expand detection of single analytes into a unique saliva multiplex assay format which simultaneously and delivers T and C results within minutes. This opens up the opportunity for further salivary point-of-care biomarker panels with near instant results. We will enhance product mobility for individual multipoint monitoring through Bluetooth compatibility and customizable algorithms available to the user through a Smart Phone App. Since T can change dramatically within a short period of time, for research and monitoring purposes, the ability to receive results within minutes is critically important to visualizing T in a physiologically responsive manner. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page

Public Health Relevance Statement:
Project Narrative Billions of dollars and thousands of lives are lost due to health problems resulting, in part, from risky decision- making, especially within young populations such as adolescents. The biomarker testosterone provides insight into the neurobiology of risky decision-making given that acute testosterone levels profoundly impact decision- making in social contexts. A critical barrier to progress in the field is that current testosterone detection methods are not time-sensitive as turnaround times from laboratories provide results within days to weeks. The present proposal uses an innovative salivary diagnostic device to quantitatively measure salivary testosterone levels in real-time; we then extend application for this point-of-care real-time assay to a multiplex platform to measure cortisol and testosterone and with mobile technology by connecting our reader with mobile “smartphones” via Bluetooth and designing customizable algorithms to immediately return interpretable results to the researcher.

Project Terms:
Accidents; Acute; addiction; Address; Adolescent; Aggressive behavior; Aging; Algorithms; antibody conjugate; Attention; base; behavior influence; Biological Assay; Biological Markers; biomarker panel; Bluetooth; Buffers; Car Phone; Cellular Phone; Clinical; Collection; Communities; Computer software; cost; Coupled; cross reactivity; Decision Making; design; Detection; Development; Devices; Diagnostic; Ecological momentary assessment; Empirical Research; Ensure; Feedback; fitness; Gender; Gonadal Steroid Hormones; Health; Hormones; Human; Hydrocortisone; Image Analysis; Immunoassay; improved; Individual; Industry; industry partner; innovation; insight; Internet; Iowa; Laboratories; Lateral; Link; male; Measurement; Measures; Mental Health; Methodology; Methods; Mind; mobile application; mobile computing; mobility enhancement; Monitor; mortality; National Institute of Drug Abuse; Nature; Neurobiology; Neuroendocrinology; new technology; novel; Outcome; Participant; Performance; Persons; Pharmaceutical Preparations; Phase; physical conditioning; Physiological; Physiology; point of care; Population; portability; Principal Investigator; Process; programs; Protocols documentation; prototype; psychobiology; Reader; Reading; Relapse; Reporting; Research; Research Personnel; response; Risk; Risk Behaviors; Saliva; saliva diagnostic; Salivary; salivary immunoassay; Sampling; Series; sex; Small Business Innovation Research Grant; smartphone Application; social; Social Environment; Specimen; Sports; Sports Medicine; steroid hormone; Steroids; Strategic Planning; Stress; success; Technology; temporal measurement; Test Result; Testing; Testosterone; testosterone replacement therapy; Time; tool; United States National Institutes of Health; Universities; user-friendly;