Real-Time Salivary Testosterone and Extension to Mobile Application and Multiple Biomarker Quantification Capability

Program Director Principal InvestigatorLastFirstMiddleSloweyPaul DAbstract This phase I NIH SBIR proposal seeks support for an interdisciplinary partnership between Oasis Diagnosticsand 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 collectionVerOFytestosteroneThe FDA has urged caution regarding clinical use of T replacement therapycalling for more research and greater differentiation of clinical vs experimental applicationnoting thatlow Tis often treated without being measured once or more frequentlyWe share this cautionary tone and designed VerOFytestosterone to better understand how T works endogenously in the body and changes in response to situational context at the momentat the point of careand non invasively using saliva specimensCurrentlyit is impossible to uncover T changes until days to weeks laterwhich poses a critical barrier to research or monitoring applicationsThe present proposal targets T in order to make a strong impact on risky decision making researchRisky decisionsespecially in young populationsimpact on mental and physical health outcomessuch as drug initiation and abuserisky sexaccidents and early mortalityThe applications for POC T testing go well beyond the implications for decision making in the research communityand the true size of the market is much larger with applications in the fields of neurobiologyneuroendocrinologypsychobiologygender developmentprofessional sports teamssports medicinefitnessstress and wellnessRapidquantitative salivary T measurement may be convenient for novel applications on the physiology of competitive sports and performance enhancementThe commercial potential is estimated to be high based on a growing billion dollar hormone testing industry and a burgeoning wellness marketThe product to be developed is a rapid point of carenon invasive TestosteroneTassayThis technologybased upon the VerOFyproprietary technologyis comprised ofathe Super SalExtra Saliva Collection devicebthe analyte specific LFT cartridge andcthe LIAMLitebox Image Analysis Modulereading device with portability to mobile technologiesThis builds from our prior success in developing VerOFycortisol which shows that this team can feasibly deliver SBIR relevant resultsNo other commercial entity has created an LFIA point of care platform that provides immediate results for T from salivaQuantitative T assessment in saliva at the POC is innovative in itselfwe further propose innovationsWe will expand detection of single analytes into a unique saliva multiplex assay format which simultaneously and delivers T and C results within minutesThis opens up the opportunity for further salivary point of care biomarker panels with near instant resultsWe will enhance product mobility for individual multipoint monitoring through Bluetooth compatibility and customizable algorithms available to the user through a Smart Phone AppSince T can change dramatically within a short period of timefor research and monitoring purposesthe ability to receive results within minutes is critically important to visualizing T in a physiologically responsive mannerOMB NoRevApproved ThroughPage Continuation Format PageProject Narrative Billions of dollars and thousands of lives are lost due to health problems resultingin partfrom risky decisionmakingespecially within young populations such as adolescentsThe biomarker testosterone provides insight into the neurobiology of risky decision making given that acute testosterone levels profoundly impact decisionmaking in social contextsA 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 weeksThe present proposal uses an innovative salivary diagnostic device to quantitatively measure salivary testosterone levels in real timewe 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 mobilesmartphonesvia Bluetooth and designing customizable algorithms to immediately return interpretable results to the researcher