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

VerOFy 第二阶段：提高压力研究生产力的新工具

• 批准号: 8523632
• 负责人: Paul Desmond Slowey
• 金额: $ 73.39万
• 依托单位: OASIS DIAGNOSTICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8523632
• 关键词: Acute; Biological Assay; Biological Markers; Biotin; Blinded; Budgets; Buffers; Child; Clinical; Clinical Protocols; Collection; Computer software; Computers; Critiques; Data; Data Collection; Detection; Development; Devices; Discipline; Economics; Engineering; Enzymes; Evaluation; Feedback; Filtration; Funding; Future; Goals; Grant; Hand; Health; Human; Hydrocortisone; Image; Image Analysis; Immunoassay; Individual; Individual Differences; Institutes; Laboratories; Lateral; Letters; Marketing; Measurement; Measures; Medical; Mental Health; Mentally Ill Persons; Methods; Minority; Modeling; National Center for Complementary and Alternative Medicine; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; National Institute of Drug Abuse; National Institute of Mental Health; National Institute on Alcohol Abuse and Alcoholism; Outcome; Participant; Performance; Phase; Population; Problem behavior; Process; Product R; Production; Productivity; Protocols documentation; Quality Control; Reader; Reading; Recovery; Reporting; Research; Research Activity; Research Personnel; Research Support; Risk; Saliva; Salivary; Sampling; Shipping; Ships; Signal Transduction; Site; Small Business Innovation Research Grant; Stress; System; Technology; Telephone; Testing; Time; United States National Institutes of Health; absorption; acute stress; base; commercialization; cost; cross reactivity; dissemination research; experience; file format; human subject; impression; improved; innovation; meetings; new technology; physical conditioning; point of care; prototype; public health relevance; response; saliva diagnostic; sample collection; stressor; time use; tool; user-friendly

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.

描述（由申请人提供）：此II阶段SBIR建立在R43-AT006634的活动上，“ Verofy：提高生产率并降低压力研究成本的新工具”。开发了集成样品收集系统的技术，这些技术在样本收集后的几分钟内非侵入性测量唾液皮质醇水平；这是对传统免疫测定的实质性改进，在几天到几个月中，皮质醇浓度未返回。预计由于皮质醇经常变化，并且在此测量特定时间延迟期间丢失了有关压力的关键信息，因此预计这一创新对压力研究会产生很大的影响。 Verofy（R）也具有创新性，因为与传统协议相比，它降低了成本，这些协议需要对样品进行测定，而无论其效用如何。因此，使用Verofy（R）技术的实时护理皮质醇测量代表了压力研究的实质性提高和重大成本。第一阶段的活动在分配的项目时间范围内完成。此外，通过使用人类参与者的试验样品测试系统，并将技术开发为完全定量的格式，该技术的发展范围超出了初始目标，该系统能够与信号线分析的互补创新进行实时测量唾液皮质醇，称为Lightbox Image Analysis（Liamtm）Portable Portable Reader。为了全面回应第一阶段的批评，进行了这些附加的活动。拟议的II期活动通过（1个最终确定Verofy（R）设备的质量控制（例如，确定恢复，敏感性，精度等）；（2）验证LIAMTM读取器通过简化读取器流程和探索智能手机应用程序（和3）有效的（3）有效的（3），以实时定量的皮质溶液结果；（在既定的环境以及六个在战略上选择代表美国每个地区的β地点，并涵盖了与这些研究活动并行的产品评估的范围。每个人的方案，并通过唾液皮质醇迅速响应地确定压力。未来的方向说明了将技术向前推进仅限研究应用程序的计划，因为该团队在先前的技术方面取得了成就。 Verofy（R）在应力场内打开了新的未开发的可能性。这项技术的影响可能是巨大的，因为在美国，与压力有关的疾病和健康问题的年度经济损失超过了2000亿美元，NIH资助了8300万美元与压力有关的研究，仅在2012年就利用了唾液皮质醇。