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

描述（由申请人提供）：该i期NIH SBIR提案是为了支持一个跨学科项目，涉及Oasis Diagnostics(R) Corporation, Madison Biodiagnostics， LLC和New Orleans大学，他们寻求合作演示一种创新的唾液收集和分析系统（VerOFy(R)），用于在临床实验室测量实时应激反应的采样点测量皮质醇水平。创新的VerOFy(R)快速口腔液体测试平台（US PN 7,618,591）是一个集成的样本收集和实验室处理系统，通过连接到免疫层析试纸的专有吸收垫收集唾液，在样品收集的几分钟内，在试纸上产生一系列与获得的唾液样本中不同皮质醇水平相关的信号。美国国立卫生研究院每年为压力相关研究提供2200万美元的资金。在压力激素皮质醇可以在唾液中无创测量后，研究取得了实质性进展。唾液皮质醇可以说是针对压力相关疾病的广泛研究方案中最常用的生物标志物。目前的提案在压力研究方面取得了重大进展，具有推进该领域的潜力，就像唾液测试一样。使用VerOFy(R)技术的实时护理点皮质醇测量能力代表了压力反应性研究的实质性生产力提高和成本降低。我们估计，在美国国立卫生研究院每年用于这项研究的2200万美元中，有30%到50%在目前的实践中可能产生很少或可疑的研究效益，而使用VerOFy(R)设备可能会节省成本。VerOFy(R)在压力研究和相关领域开辟了新的、未探索的可能性，为每个人量身定制或个性化方案，包括快速确定压力无反应者。它进一步为压力相关研究中皮质醇测量的标准化方法提供了机会。这项创新的成本和时间效益将扩展到美国国立卫生研究院资助的2200万美元的研究项目，这些项目依赖于皮质醇水平的测量来识别压力反应，为美国国立卫生研究院资助的压力相关研究带来实质性的成本降低和生产力提高。第一阶段将演示VerOFy(R)技术对皮质醇标准控制溶液的验证。该项目的第二阶段将证明这种新方法在提高研究成果和降低压力相关研究成本方面的有效性。

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.