I-Corps: Portable Autonomous Biomarker Sampling Technology (PABST)

我们体内的化学物质是医学诊断和检测的下一个前沿。目前对患者健康的医学测试主要是在家中(即在医院或医生办公室)进行的不频繁的测试。这种在医疗诊断中占主导地位的欠抽样模式导致了在充分了解患者健康方面的持续偏见。在患者出院后，如果没有足够的知识了解患者体内化学物质的变化，以及这种化学物质是如何由于环境压力、药物治疗或其他治疗而发生变化的，就不可能做出患者的“天气报告”。在医生办公室或诊所进行测试，对患者一天或一周的变异性几乎没有洞察力。这个i-Corps团队设计了一种便携式生物标记物自动采样技术，可以安装在马桶上，创建一个智能的非侵入性采样系统，用于家庭中的尿液生物标记物。在一段规定的时间内从尿液中捕获的生物标志物被运往实验室进行分析测试，然后可以了解患者的生化历史，达到医疗保健行业前所未有的详细程度。医生将有一个强大的工具来绘制一个人的身体健康状况图。这项技术最初是为海洋观测而开发的，目的是了解海洋化学和生物的时空变化，现在可以应用于测量人类健康的变化和反应。该项目的目标是促进拟议诊断创新的产品和商业潜力，这是一种便携式生物标记物机器人采样器，可在家中用于尿液中的生物标记物采样。来自家庭的样本可以与基于临床实验室的生物标记物测试相结合，以允许首次对患者进行高频、精确的医学和个人观察。该项目的预期结果是以客户发现为导向，为Biomarker采样器产品和服务制定商业化计划。I-Corps团队预计还将包括使用自动化系统与潜在客户、第三方供应商和外部制造商进行协作演示，以验证和增强当前采样器设计的有效性。工程设计更改将根据客户反馈和演示测试结果进行。同时，该团队将研究家庭自动化系统的当前和未来市场、其分销渠道和潜在的合作机会。根据团队开发的结果，团队将确定适当的业务战略，将自动化系统推向市场。在项目结束时，该团队希望拥有一个可扩展的自动化核心，有效地实现关键生物标志物的自动化定量采样，准备在实验室进行分析，以实现独特的、行业变化的“患者天气”报告。

Chemistry in our bodies is the next frontier for medical diagnostics and testing. Current medical testing of patients for their health is dominated by infrequent testing out of the home (i.e. at the hospital or doctor's office). This under-sampling paradigm which has dominated healthcare diagnostics has led to a persistent bias in fully understanding patient wellness. A patient "weather report" cannot be done without sufficient knowledge of the changes of the patient's internal chemistry and how that chemistry is changing due to environmental stress, drug therapy or other treatments on a patient after they leave the hospital. Testing at the doctor's office or clinic yields minimal insight into variability of a patient throughout the day or over the week. This I-Corps team has devised a Portable Biomarker Autonomous Sampling Technology that can be attached to a toilet to create an intelligent non-invasive sampling system for urine biomarkers in the home. The biomarkers captured from urine over the course of some prescribed period are shipped to a lab for analytical testing and the biochemical history of the patient can be then understood to a level of detail never before allowed in the healthcare industry. Doctors will have a powerful tool to chart a person's physical well-being. The technology was originally developed for ocean observations to gain understanding of the spatial and temporal change of the chemistry and biology of the oceans and now can be applied to measuring human health changes and responses.The goal of the project is to advance both the product and the business potential of the proposed diagnostic innovation which is a portable biomarker robotic sampler for in-the-home use for biomarker sampling in urine. Samples from the home can be coupled to clinical laboratory-based biomarker testing to allow for high frequency, precision medicine and personal observations of a patient for the first time. An expected outcome of this project is the customer-discovery guided development of a commercialization plan for the Biomarker Sampler products and services. The I-Corps team expects to also include collaborative demonstrations using the automation system with potential customers, third party vendors, and outside manufacturers to validate and enhance the effectiveness of the current sampler design. Engineering design changes will occur based on customer feedback and demo-testing results. In parallel, the team will research the current and future markets for the in-home automation system, its distribution channels, and potential partnership opportunities. Based on the outcomes of the team's development, the team will determine the appropriate business strategy to move the automation system to market. At the end of the project, the team expects to have a scalable automation core that effectively enables automated quantitative sampling of key biomarkers ready for analysis in the laboratory to allow for unique, industry changing "patient weather" reporting.