I-Corps: Secure and Compliant Smartphone Readable Diagnostics via Machine Intelligible Matrix Assays

这个I-Corps项目的更广泛的影响/商业潜力使日常用户能够参与一种称为“自我量化”的新医疗趋势。“自我量化可以让个人更深入地了解自己的身体状态，使他们能够采取更积极和精确的方法来优化自己的健康。 我们的创新为低成本、消费者规模的自我量化提供了一种方法。我们的技术同时为健康平台提供商提供安全、合规的自量化数据传输服务。 我们确定了四个主要客户群，包括1）专业诊断开发人员，2）数字和移动的“自我量化”健康提供商，包括智能手机健康/健身移动的应用程序，3）学术/企业临床研究人员和4）流行病学家。 这些客户群充当将使用产品的最终用户的分销渠道。 在商业上，我们的产品将渗透到2020年460亿美元的移动的健康市场。 广泛地说，随着该技术的广泛使用和扩展，包括对各种预防性、疾病和稳态生物标志物的患者去识别化监测，当前的医疗保健监测计划将通过地球物理数据得到增强，从而改善疾病和健康跟踪。 这将使预测分析的全面实施，增强研究人员跟踪，监测和最终预测全球健康和疾病的方式。这个I-Corps项目旨在对“自我量化”用户和数字健康平台提供商进行彻底的客户发现过程，以确定最有价值的产品参数，然后将我们的创新产品转化为市场准备产品。 我们的创新提供了一个无缝平台，使消费者能够通过跟踪家中的生物标志物来“自我量化”。 这项活动将为研究和预测/相关的健康结果产生有用的数据。我们的交钥匙解决方案使任何移动的健康平台都能够将智能手机兼容的快速诊断测试（RDT）纳入其产品组合，同时利用我们的软件服务将智能手机可读的诊断结果安全地传输到符合政府法规的在线数据库。 这方面将是一种使能技术，可用于不断扩大的移动的健康技术生态系统中的其他用途。我们的RDT将使用侧流检测夹心方法，利用元型抗体和金纳米颗粒合成。在存在尿液生物标志物的情况下，将形成专有的智能手机可理解的模式。我们的方法的技术实现使用金纳米技术过程和协议。 例如，用于生成核-壳磁性纳米颗粒的基本合成工艺和方案将用于合成纳米酶纳米技术，该技术包括我们提出的智能手机可读快速诊断测试。该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的知识价值和更广泛的影响审查标准进行评估来支持。

The broader impact/commercial potential of this I-Corps project empowers everyday users to participate in a new healthcare trend called 'self-quantification.' Self-quantification allows individuals to obtain a deeper understanding of the state of their body, empowering them towards more proactive and precise approaches to optimize their health. Our innovation provides an approach for low-cost, consumer scale self-quantification. Our technology simultaneously provides the health platform providers a secure, compliant transmission service for self-quantified data. We have identified four primary customer segments which include 1) professional diagnostic developers, 2) digital and mobile 'self-quantification' health providers which include smartphone health/fitness mobile applications, 3) academic/corporate clinical investigators and 4) epidemiologists. These customer segments act as distribution channels to the end users who will use the product. Commercially, our product will penetrate a $46 billion 2020 mobile health market. Broadly, with widespread use and the expansion of this technology to include the patient de-identified monitoring of a variety of prophylactic, disease and homeostatic biomarkers, current healthcare surveillance programs would be enhanced with geophysical data, improving both disease and wellness tracking. This would enable the full implementation of predictive analytics, enhancing the way researchers track, monitor and eventually predict wellness and disease worldwide.This I-Corps project seeks to perform a thorough customer discovery process of 'self-quantification' users and digital health platform providers to identify the most valuable product parameters before formulating our innovation into a market-ready product. Our innovation provides a seamless platform which empowers consumers to 'self-quantify' by tracking biomarkers at home. This activity will generate useful data for research studies and predictive/correlative health outcomes. Our turnkey solution enables any mobile health platform with the ability to incorporate smartphone-compatible rapid diagnostic testing (RDT) into its product portfolio while utilizing our software service to securely transmit smartphone-readable diagnostic results to online databases in accordance with government regulations. This aspect will be an enabling technology for other uses in the expanding mobile health technology ecosystem. Our RDT will use a lateral flow assay sandwich approach utilizing metatype antibodies and gold nanoparticle synthesis. Proprietary smartphone-intelligible patterns will be formed in the presence of urinary biomarkers. The technological implementation of our approach uses gold nanotechnology processes and protocols. For example, the underlying, fundamental synthesis processes and protocols used to generate core-shell magnetometallic nanoparticles will be utilized in the synthesis of nanozyme nanotechnology which comprises our proposed smartphone-readable rapid diagnostic test.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.