Project Summary
Today, researchers and clinicians, in academia and industry, lack the tools and technologies needed to
accurately characterize, differentiate, and sort extracellular vesicles (EVs); currently available technologies were
simply not developed to characterize entities smaller than 200 nanometers in size. While the importance of EVs
in directing cargo delivery for intercellular communication is well known, the inability to profile the true distribution
of their biophysical properties is the main hindrance to understanding the mechanisms of action, identifying
disease-specific biomarkers, and harnessing the therapeutic potential of EV-based nanomedicine. During this
Phase I STTR program, Electronic BioSciences (EBS), a company with a successful track record of
commercializing nanopore-based analytical technology and the associated high-performance, low-noise
electronics, will collaborate with Distinguished Professor Henry S. White at the University of Utah, who is a
foremost expert in nanopores, mass transport and electroanalytical characterization, to develop and demonstrate
an entirely new technology capable of state-of-the-art, comprehensive EV characterization and sample profiling
at the single-vesicle level. Furthermore, the ability to quickly assess individual EVs will enable the ability to sort
and isolate specific EV subpopulations for further downstream characterization and/or utilization. During this
project, a prototype system will be built and the feasibility of comprehensively characterizing and sorting/isolating
specific EV populations will be demonstrated and validated. The resulting system will have the ease-of-use,
throughput, and price point of a high-throughput, “low-resolution” flow-cytometer, but the resolution of state-of-
the-art microscopy techniques, such as scanning or transmission electron microscopy (SEM or TEM,
respectively) or atomic force microscopy (AFM). The advantage of the proposed technology will be the
development of a system enabling the ability to identify and sort/isolate precisely defined populations of
biological- and medical-significance nanoscale (<200 nm) entities using high-dimensional (multiparameter) data,
which will have applications far beyond EVs, including but not limited to characterizing other nanostructures
important in drug delivery and gene therapy nanomedicines such as lipid nanoparticles for vaccines, exosome-
based therapeutics, lentivirus, virus-like particles, and polymer-based nanocapsules. Thus, the successful
completion of this program will result in a broadly applicable tool able to bring precision to bear on these smallest
of couriers and enable the characterization/classification urgently needed to advance the fields of EVs and
nanomedicine.