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

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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.