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

描述（由申请人提供）：本阶段II SBIR基于R43-AT 006634“VerOFy：一种提高生产力和降低压力研究成本的新工具”的活动。开发了一种集成样品收集系统的技术，该系统在样品收集的几分钟内非侵入性地测量唾液皮质醇水平;这是对传统免疫测定的实质性改进，在传统免疫测定中皮质醇浓度在几天到几个月内不会返回。这一创新预计将对压力研究产生重大影响，因为皮质醇经常变化，并且在这种测量特定的时间延迟期间丢失了有关压力的关键信息。VerOFy（R）也是创新的，因为与传统的方案相比，它降低了成本，传统的方案需要对样品进行分析，而不管它们的效用如何。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显著生产力提高和主要成本降低。第一阶段的活动在规定的项目时间内顺利完成。此外，该技术通过使用人类参与者的试点样本测试系统并将该技术发展为能够实时测量唾液皮质醇的完全定量格式，并结合用于信号线分析的补充创新，即Lightbox图像分析模块（LIAMTM）便携式阅读器，大大超出了最初的目标。开展这些补充活动是为了全面回应第一阶段的批评意见。拟议的第二阶段活动通过（1）完成VerOFy（R）器械的质量控制（例如，确定回收率、灵敏度、精确度等）;（2）通过简化读取器过程和探索智能手机应用程序的用户友好技术进步，验证LIAMTM读取器的实时定量皮质醇结果;以及（3）在已建立的环境中用人类参与者验证VerOFy（R）和LIAMTM，以及六个β-战略性地选择代表美国每个地区的地点，并涵盖产品评估的一系列专业知识。在开展这些研究活动的同时，还介绍了一项详细的商业化计划，根据调查小组和研究人员及有关专家咨询委员会以往的经验，这项技术可以在市场上得到切实可行的推广。到第二阶段结束时，目标是拥有一个全面运作的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反应。未来的发展方向说明了将该技术向前推进的计划，超出了仅供研究使用的应用程序，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，仅在2012年，美国国立卫生研究院就资助了8300万美元的与压力相关的研究。

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.