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

描述（由申请人提供）：第二阶段 SBIR 建立在 R43-AT006634“VerOFy：提高生产力和降低压力研究成本的新工具”活动的基础上。开发了集成样本采集系统技术，可在样本采集后几分钟内非侵入性地测量唾液皮质醇水平；与传统的免疫测定法相比，这是一个重大改进，在传统的免疫测定法中，皮质醇浓度在几天到几个月内都不会返回。这项创新预计将对压力研究产生重大影响，因为皮质醇会频繁变化，并且在测量特定时间延迟期间会丢失有关压力的关键信息。 VerOFy(R) 还具有创新性，因为与传统方案相比，它降低了成本，传统方案需要对样品进行分析，而不管其用途如何。因此，使用 VerOFy(R) 技术进行实时护理点皮质醇测量代表了压力研究生产力的显着提高和成本的大幅降低。第一阶段的活动在指定的项目时间内顺利完成。此外，通过使用人类参与者的试点样本测试该系统，并将该技术开发为能够实时测量唾液皮质醇的完全定量格式，并结合信号线分析的补充创新（称为灯箱图像分析模块（LIAMTM）便携式阅读器），该技术大大超出了最初的目标。开展这些新增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以下方式进一步扩展这些活动：(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) 通过简化读取器流程并通过智能手机应用程序探索用户友好的技术进步来验证 LIAMTM 读取器的实时定量皮质醇结果；(3) 在既定环境中与人类参与者一起验证 VerOFy(R) 和 LIAMTM 以及战略性选择的六个测试站点在开展这些研究活动的同时，还描述了一项详细的商业化计划，根据研究团队和研究人员顾问委员会以及相关专家的先前经验，我们的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为每个人制定个性化方案，并通过唾液皮质醇快速确定压力。 VerOFy(R) 团队已在压力领域取得了突破性成果，使该技术超越了仅限研究用途的应用范围。该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，而且仅 2012 年，NIH 就已资助了 8300 万美元的压力相关研究。

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.