SBIR Phase I: High-Throughput Nanoparticle Characterization for Life Sciences Applications

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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.