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

描述(申请人提供)：该第二阶段SBIR建立在R43-AT006634的活动基础上，“VerOFy：一种提高生产力和降低压力研究成本的新工具”。开发了一种集成样本收集系统的技术，它可以在样本收集后几分钟内非侵入性地测量唾液皮质醇水平；这比传统的免疫分析方法有了很大的改进，在传统的免疫分析方法中，皮质醇浓度要几天到几个月才能恢复。这一创新预计将对压力研究产生巨大影响，因为皮质醇经常变化，在这种测量特定的时间延迟期间，关于压力的关键信息会丢失。VerOFy(R)还具有创新性，因为与传统协议相比，它降低了成本，因为传统协议要求对样品进行检测，而不管其用途如何。因此，使用Verofy(R)技术的实时护理点皮质醇测量对于压力研究来说代表着生产力的显著提高和成本的大幅降低。第一阶段的活动在分配的项目时限内顺利完成。此外，这项技术的进步大大超过了最初的目标，方法是用来自人类参与者的试点样本测试该系统，并将该技术开发成能够实时测量唾液皮质醇的全定量格式，同时还结合了信号线分析的补充创新，称为Lightbox图像分析模块(LIAMTM)便携式阅读器。开展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、精密度等)；(2)通过简化阅读器流程并探索智能手机应用程序中用户友好的技术进步，验证LIAMTM阅读器的实时定量皮质醇结果；以及(3)在既定的环境中与人类参与者一起验证Verofy(R)和LIAMTM，以及战略性地选择代表美国每个地区并涵盖一系列产品评估专业知识的六个测试点。在这些研究活动的同时，还描述了一项详细的商业化计划，根据该计划，这种技术可以根据调查小组和研究人员顾问委员会和相关专家的先前经验进行可行的市场推广。到第二阶段结束时，目标是拥有一种完全运行的Verofy(R)设备，使压力研究人员能够为每个人制定个性化的方案，并通过唾液皮质醇快速确定压力。未来的方向说明了将该技术向前推进的计划，超越了仅供研究使用的应用程序，就像团队使用先前的技术所完成的那样。Verofy(注册商标)在应力场中开辟了新的、尚未探索的可能性。这项技术的影响可能是巨大的，因为在美国，与压力相关的疾病和健康问题每年造成的经济损失超过2000亿美元，而美国国立卫生研究院仅在2012年就资助了8300万美元的与压力相关的研究，这些研究利用了唾液皮质醇。

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.