The broader impact/commercial potential of this Small Business Technology Transfer (STTR) project is the development of a widely deployable, inexpensive and accessible diagnostic platform that can rapidly detect infectious diseases in clinical and non-clinical locations, including settings with minimal infrastructure. While the platform technology itself is applicable to the detection of a wide number of pathogenic agents such as viruses, bacteria, and parasites, this proposal optimizes, evaluates, and demonstrates functionality and feasibility for Sexually Transmitted Infections (STIs). The development of this technology will aid widespread screening efforts involving early diagnosis of infectious diseases, inform optimal patient treatment, and potentially act as a test-of-cure. The accessible and rapid DNA-based diagnostic platform proposed in this project, bypasses centralized laboratory testing, and eliminates systemic inefficiencies within traditional healthcare infrastructure. Potentially, this would expand the reach of the medical community and improve access to healthcare. Nowhere is this ability needed more than in the global infectious disease diagnostic market, which generates $12.4B and currently dominated by outdated technologies that have poor performance. A consumer-oriented, rapid DNA diagnostic test would be a disruptive paradigm shift, and would address many of the current challenges in infectious disease management and control. This STTR Phase I project proposes to develop a rapid, accessible, and inexpensive DNA-based diagnostic test for the detection of infectious diseases. Current nucleic acid amplification tests (NAATs) rely on immobile benchtop equipment that is constrained to centralized diagnostic laboratories, often necessitating experienced technicians to operate, and a period of at least 24 hours to report results. Consequently, the prolonged time for results leads to the presumptive diagnosis of at-risk individuals, excessive administration of antibiotics, and patient loss due to lack of follow up. A rapid NAAT, deployable at the point-of-care with results reported in less than 45 minutes, would represent a paradigm shift in the diagnosis of several infectious diseases. To this end, the proposed platform has been miniaturized, and all the necessary steps required to perform NAAT have been integrated into a disposable, self-powered, and instrumentation-free platform. The proposed approach operates in settings with minimal resources such as a public clinic, yet has advanced capabilities for the multiplexed detection of strain variants and genomic markers of drug-resistance, while providing highly sensitive and specific detection in less than 45 minutes. In this proposal, we will further develop the sample preparation module, integrate the nucleic acid amplification reaction into the platform, and validate instrumentation-free readout capabilities.
