A research team led by Professor Ju-Hwan Park of the Department of Bio-Fermentation and Convergence at Kookmin University and Professor David Issadore of the University of Pennsylvania (UPENN) has jointly developed GDEVA, a single EV ultra-high sensitivity and large-scale analysis platform that can identify rare subpopulations of extracellular vesicles (EVs) in blood. This study was published in the prestigious nanotechnology journal ACS Nano (IF: 15.8).

Extracellular vesicles (EVs) in blood are gaining attention as important biomarkers for the early diagnosis and treatment response prediction of intractable diseases such as cancer and immune disorders. In particular, ultra-high-sensitivity, multi-parameter, and large-scale analysis at the single EV level is considered a core technology for realizing personalized precision medicine. However, existing exosome analysis technologies have limitations in terms of sensitivity, throughput, and multiplexing, making it difficult to precisely distinguish rare exosome subtypes in blood. To address these technical challenges, the research team conducted the study with the goal of developing a platform applicable in clinical settings.

GDEVA (Gel-based Digital single-molecule–single EV Assay) is a hydrogel-based exosome digital quantification analysis platform technology. By selectively labeling proteins expressed on the surface of single exosomes, encapsulating them in hydrogel beads, and simultaneously amplifying protein signals at the single-particle level through in situ cleavable RCA (rolling circle amplification), the technology enables digital quantification analysis of biomarkers at the single exosome level.

The research team utilized the ‘GDEVA’ technology to analyze cancer/immune-related biomarkers at the single exosome level in the plasma of skin cancer patients, thereby demonstrating the ability to precisely analyze even rare exosome subtypes present in extremely low quantities in blood. This is evaluated as a foundational technology that can significantly contribute to predicting cancer immunotherapy responses and precise diagnosis.

Professor Ju-Hwan Park said, “This research is a result of the convergence of microfluidic precision diagnostic technology and cutting-edge nanobiotechnology, solving the technical challenge of ultra-high-sensitivity mass analysis of single exosomes. It can be applied to a wide range of fields, including not only cancer but also autoimmune, infectious, and degenerative diseases, enabling the realization of personalized precision medicine.”

This research was conducted with support from the Ministry of Environment's Eco-Biomaterial Advanced Talent Cultivation Specialized Graduate School Program (Director Park Yong-chul).

Paper Title: Agarose Microgel-Based In Situ Cleavable Immuno-Rolling Circle Amplification for Multiplexed Single-Molecule Quantitation on Single Extracellular Vesicles DOI: https://doi.org/10.1021/acsnano.5c04207