SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovative Research (SBIR) project is to develop a detection technology that enables scientists and researchers to better understand biological particles circulating in biofluids. This improved understanding would lead to new disease diagnostics that could improve patient outcomes and reduce healthcare costs. The technology being developed allows high-throughput detection and characterization of exosomes, which are nanovesicles produced by cells and released in all biological fluids (e.g., blood, saliva, and urine). Exosomes are being investigated for early detection of diseases, including cancer, cardiovascular, and neurodegenerative disorders, from biofluids without the need of invasive tissue biopsies. Early detection of disease from a simple blood or urine test allows discovery of disease at an earlier point making treatments more effective and reduces the need for costly and invasive procedures that could cause further complications. Furthermore, the same technology being developed also may be used to aid in the manufacturing of next-generation therapeutics that use exosomes to combat cancer, cardiovascular and neurodegenerative diseases. This SBIR Phase I project proposes to develop a customer-configurable cartridge that will allow customization of biological probes to identify and measure specific populations of exosomes based on their surface markers. Exosomes, which are nanoparticles (50-200 nm) shed by cells into biological fluids, are being investigated for early detection of diseases, including cancer, cardiovascular, and neurodegenerative disorders. Exosomes, which are biologically active, may be found at high concentrations compared to other biomarkers, but their small size makes them very difficult to characterize with current techniques. This proposal is to create a high-throughput platform to address exosome characterization requirements through two development aims: 1) Develop, validate, and demonstrate a disposable microfluidic device that will allow customers to configure the assay for characterization of specific populations of exosomes, and 2) enable robust detection and identification of the smallest populations of low-index exosome nanoparticles, down to 50 nm, allowing complete exosome sizing in a high-throughput platform. The completion of these objectives will result in a product to be sold to researchers working on nanoparticle-based diagnostics and therapeutics.

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.