The broader impact / commercial potential of this Small Business Innovation Research (SBIR) Phase I Project is to reduce time-to-diagnosis for COVID-19 through the development of a novel all-electronic single-molecule molecular diagnostics platform. The proposed technology has the potential to eliminate sample processing bottlenecks that have resulted in delayed diagnosis. The system's form-factor is compact and widely deployable, enabling point-of-care and/or near-point-of-care test settings. The system comprise a reader unit and disposable test-chips. This will enable rapid testing. This Small Business Innovation Research (SBIR) Phase I project will advance a prototype of a all-electronic single-molecule molecular diagnostics platform and demonstrate direct detection of SARS-CoV-2 RNA. Prototype completion will involve integrating our single-molecule biosensors onto application-specific integrated circuitry and optimizing the chemical functionalization process to enable single-molecule detection. Processes will be developed for controlled RNA fragmentation, required for direct RNA detection. Direct detection will eliminate the need to perform extensive enzymatic processing required in quantitative Reverse-Transcription Polymerase-Chain-Reaction (qRT-PCR)-based systems. Efficient data processing algorithms will be designed and implemented in the data acquisition hardware to accelerate diagnosis.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.
