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

描述（申请人提供）：本1期NIH SBIR提案旨在支持一项跨学科计划，该计划涉及Oasis Diagnostics（R）Corporation，麦迪逊生物诊断有限责任公司，和新奥尔良大学，他们寻求合作展示一种创新的唾液收集和分析系统，（VerOFy（R））用于在临床实验室中测量真实的时间应激反应的采样点测量皮质醇水平。 创新的VerOFy（R）快速口腔液检测平台（US PN 7，618，591）是一个集成的样本采集和实验室处理系统，通过连接到免疫色谱测试条的专有吸收垫收集唾液，在测试条上产生一系列信号线，这些信号线与样本采集后几分钟内获得的唾液样本中不同的皮质醇水平相关。压力相关的研究蓬勃发展，每年由NIH资助2200万美元。在压力荷尔蒙皮质醇可以在唾液中非侵入性地测量之后，取得了实质性的研究进展。唾液皮质醇可以说是最常见的生物标志物，用于针对压力相关疾病的广泛研究方案。目前的建议追求压力研究的重大进展，具有推动该领域发展的潜力，就像唾液测试一样。使用VerOFy（R）技术的真实的时间点护理皮质醇测量能力代表了压力反应研究的显著生产力提高和成本降低。我们估计，NIH每年用于这项研究的2200万美元中的30%到50%在目前的实践中可能产生很少或可疑的研究效益，并且可能通过使用VerOFy（R）设备而节省。VerOFy（R）在压力研究和相关领域开辟了新的、未经探索的可能性，为每个人定制或个性化方案，包括快速确定压力无反应者。它进一步代表了一个标准化的方法来测量皮质醇在压力相关的研究的机会。这项创新的成本和时间效益将扩展到NIH资助的2200万美元的研究项目，这些项目依赖于测量皮质醇水平来确定压力反应，为NIH资助的压力相关研究带来大幅成本降低和生产力提高。第1阶段将证明VerOFy（R）技术对皮质醇标准对照溶液的验证。该计划的第二阶段将证明这种新方法在改善研究结果和降低压力相关研究成本方面的有效性。 公共卫生相关性：NIH资助了2200万美元的压力相关研究，这些研究依赖于测量生物标志物皮质醇作为压力反应的指标。当前皮质醇检测方法的变化使得不可能个性化实验方案和比较不同研究项目的结果。本提案使用创新的唾液诊断设备（VerOFy（R））来标准化皮质醇测量并降低与压力相关的研究成本。

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 Test Platform (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.