SBIR Phase II: High-Throughput and Scalable Nanoparticle Characterization for Life Sciences Applications

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop an instrument platform that will facilitate development and translation of next generation diagnostics and therapeutics that are based on a class of nanovesicles called extracellular vesicles (EVs). EVs, which are nanoparticles shed by cells, are being investigated for early detection of diseases, including cancer, cardiovascular disease, and neurodegenerative disorders, from biofluids without the need of invasive tissue biopsies. The lack of tools and techniques to perform high-throughput characterization of EVs is limiting translation. The platform under development will enable an understanding EVs produced by cells. The global market for nanoparticle analysis instrumentation in the life sciences is estimated at $5.9 Billion. The EV market, which is a subset of this market, is rapidly growing, with a predicted compound annual growth rate (CAGR) of 47.3% over the next five years. Biological nanoparticles are playing an increasing role in life science applications and better, target-specific, faster tools are needed to characterize them in a high-throughput way. This SBIR Phase II project will complete the development of an instrument platform to enable Extracellular Vesicle (EV) measurements and characterization. The platform will include a customer configurable consumable, eliminating the requirement for an expensive custom robotic arrayer step, removing barriers to end-user adoption and decentralizing discovery. Also, long-term shelf-life of the consumable will be established. In addition, improvements into the imaging platform will enable visualization of the smallest nanoparticles, relaxing the complexity and cost of the platform and providing a functional advantage over competitive offerings. The platform will automate much of the workflow, reducing operator hands-on time. The resulting platform will enable EV measurements with 5X-to-30X less sample volume, detect 100X-to-10,000X less concentrated targets, and increase throughput by using a workflow that bypasses purification requirements needed by other techniques. The completion of these objectives will result in a life science research tool for researchers and industry working on EV-based diagnostics and therapeutics. 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.