Phase II of VerOFy: A New Tool to Improve Productivity for Stress Research

描述（由申请人提供）：本二期SBIR建立在R43-AT006634“VerOFy：一种提高应力研究生产率和降低成本的新工具”的基础上。开发了一种集成样品采集系统技术，该系统在样品采集后几分钟内无创测量唾液皮质醇水平；这是对传统免疫测定法的实质性改进，在传统免疫测定法中，皮质醇浓度在几天到几个月内不会返回。这一创新有望对压力研究产生重大影响，因为皮质醇变化频繁，在测量特定的时间延迟期间，有关压力的关键信息会丢失。VerOFy(R)也具有创新意义，因为与传统方案相比，它降低了成本，传统方案要求对样品进行分析，而不管其效用如何。因此，使用VerOFy(R)技术的实时护理点皮质醇测量代表了压力研究的实质性生产力提高和主要成本降低。第一阶段的活动在分配的项目时间框架内完成得很好。此外，该技术的进步大大超过了最初的目标，通过对系统进行测试，从人类参与者身上获得试点样本，并将该技术发展成为一种完全定量的格式，能够实时测量唾液皮质醇，并与信号线分析的互补创新相结合，被称为Lightbox图像分析模块（LIAMTM）便携式阅读器。进行这些增加的活动是为了全面回应第一阶段的批评。拟议的第二阶段活动将这些活动进一步扩展，通过(1)最终确定VerOFy(R)设备的质量控制（例如，确定回收率、灵敏度、精度等）；(2)通过简化读取流程和探索智能手机应用程序中用户友好的技术进步，验证LIAMTM读取器的实时定量皮质醇结果；(3)验证VerOFy(R)和LIAMTM在既定环境中的人类参与者以及战略选择的代表美国每个地区的六个beta站点，并涵盖产品评估的一系列专业知识。在这些研究活动的同时，还描述了一项详细的商业化计划，其中根据调查小组和研究人员及有关专家咨询委员会的先前经验，这项技术可以切实销售。在第二阶段结束时，目标是拥有一个完全可操作的VerOFy(R)设备，使压力研究人员能够针对每个个体制定个性化方案，并通过唾液皮质醇快速确定压力反应。未来的方向说明了将技术向前推进的计划，而不仅仅是研究用途的应用，因为该团队已经完成了先前的技术。VerOFy(R)在应力场中开辟了新的、未开发的可能性。这项技术的影响可能是巨大的，因为美国每年因压力相关疾病和健康问题造成的经济损失超过2000亿美元，仅在2012年，美国国立卫生研究院就资助了8300万美元用于利用唾液皮质醇的压力相关研究。

DESCRIPTION (provided by applicant): 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.