One-to-One Fusion-Mediated Single Extracellular Vesicle Analysis for Early Screening of Breast Cancer

Single extracellular vesicle (EV) analysis offers transformative potential for early cancer screening. However, its clinical translation remains constrained by the absence of scalable, economically viable, and clinically compatible methodologies, attributable to EVs’ inherent nanoscale dimensions. To address this, we developed an EV and liposome one-to-one fusion (ELOF) technology that enlarges EVs to over 1.0 μm, enabling single EV analysis using conventional clinical equipment such as flow cytometry and fluorescence microscope. When applied to plasma samples collected from patients with potentially cancerous breast lumps, the ELOF-mediated single EV analysis demonstrated that the percentage of EV expressing breast cancer-related proteins effectively distinguished between malignant and benign lumps. The ELOF assay costs less than $0.30 per sample and can be completed within 30 min, underscoring its suitability for large-scale early breast cancer screening.