SBIR-STTR Award

We propose a next-generation reader system for Rapid Diagnostic Tests using lateral flow immunoassay cartridges. The system includes a rugged and lightweight reader that is built on a cellphone platform, a centralized data server, and bio-surveillance application software. The server communicates with readers securely over Internet, cellular and other networks. Reader design aims to provide the ultimate in accuracy, sensitivity, operability, light weight and cost, as well as the ability to read cartridges of different formats and for different indications. Using this system it will be possible to provide affordable rapid diagnostics in remote places and to collect real-time geo maps about the distribution of health conditions, spread of epidemics and biothreats.

Rapid screening of chemical/biological threats and infectious diseases is a challenging task especially in remote locations due to the lack of appropriate laboratory infrastructure and advanced instrumentation. In such resource-scarce settings, wireless, robust, accurate, and easy-to-use diagnostics tools are required to enable real-time monitoring of various medical conditions, point-of-care applications and global disease surveillance. In this Phase II proposal, we aim to continue with the advanced development of a cell-phone based rapid diagnostic test reader platform and further enhance its hardware and software capabilities. In Phase I, feasibility of this cell-phone based spatiotemporal disease surveillance platform has been demonstrated, delivering a number of prototypes with encouraging system performance. Wirelessly integrated into remote database and servers, this platform enables digital quantitative evaluation of rapid diagnostic tests (lateral flow immuno-chromatographic assays) using a snap-on hardware attachment and software application on cell-phone devices. Phase II will provide opportunity for industrial level optimization, further performance improvements and fabrication of the platform toward advanced development and commercialization. As a result of fast progress during Phase I Holomic already commercialized a Pilot Reader in order to test the market and develop business relationship. Phase II will result in a @Clinic Reader for professional point-of-care applications and a @Home Reader for consumers and patient self monitoring. These readers are market-leading with performance, features, ease of use, and affordability.

Keywords:
Rapid Diagnostic Reader, Rapid Diagnostic Tests, Lateral Flow Immunoassay, Point-Of-Care, Remote Patient Monitoring, Telemedicine, Disease Surveillance, Consumer Health