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

这个小企业创新研究（SBIR）第一阶段项目建议开发一种低成本的仪器平台，用于装载和成像数字PCR设备。微流控技术在医疗、诊断和研究应用方面具有巨大的潜力，但通常存在较高的成本和更复杂的工作流程，限制了广泛的实施。具体来说，微流体技术使dPCR领域成为可能，与基于“实时”测量的定量PCR相比，dPCR提供了更好的定量，但由于其相对较高的成本，dPCR仍然是一个利基市场。通过将简单的自数字化（SD）微流控装置与基于低成本量产仪器技术的平台相结合，将大大降低相关社区实施和采用的障碍。该项目将利用现有商业平台的原理来开发并行数字化和成像仪器原型。功能原型将验证这一成本效益的途径，并为进一步商业化提供坚实的基础。该项目的广泛影响和商业潜力，如果成功，将产生第二代dPCR平台，在价值几亿美元的dPCR市场中具有直接竞争力，并有可能改变价值数十亿美元的qPCR市场。由于SD设备的简单、封闭的系统工作流程和使其与qPCR具有竞争力的价格结构，它将提供dPCR提供的高精度定量的广泛访问。此外，该平台提供的灵活性将允许在单个平台上执行各种各样的实验。应用范围从需要大样本量的高灵敏度分析，到需要区分浓度非常接近的样品的高分辨率分析，再到高通量分析。用户友好的成本效益的dPCR平台可以促进一系列应用的研究和诊断，包括癌症研究，病毒和细菌诊断，以及个性化或患者特异性药物。

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.