SBIR Phase I: Developing Low-Cost Instrumentation for Self-Digitization-Based Digital PCR

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a low cost instrumentation platform for loading and imaging digital PCR devices. Microfluidic technology has enormous potential to impact medical, diagnostic and research applications, but generally suffers from higher costs and more complicated workflow that limits broad implementation. Specifically, microfluidics has enabled the field of dPCR, which offers superior quantification compared to quantitative PCR based on "Real-time" measurements, however dPCR has remained a niche market due to its relatively higher cost. By coupling the simple self-digitization (SD) microfluidic devices with a platform based on low-cost mass-producible instrumentation technology it will greatly reduce the barrier to implementation and adoption by the relevant communities. This project will utilize principles from existing commercial platforms to develop a parallelized digitization and imaging instrument prototype. A functional prototype would validate this cost efficient pathway and provide a strong foundation for further commercialization. The broader impact/commercial potential of this project, if successful, would result in a second generation dPCR platform that would be directly competitive within the several $100 million dPCR market, and could potentially transform the multibillion dollar qPCR market. It will provide widespread access to the high precision quantification offered by dPCR, due to the simple, closed system workflow of SD devices and a price structure that would make it competitive with qPCR. Additionally, the flexibility this platform offers would allow for a diverse set of experiments to be executed on a single platform. Applications ranging from high sensitivity assays, requiring large sample volumes, to high resolution assays, needing to differentiate samples very close in concentration, to high throughput assays would be available. A user friendly cost effective dPCR platform could facilitate research and diagnostics across a range of applications including cancer research, viral and bacterial diagnostics, and personalized or patient specific medicine.