Development of extracellular vesicles in diagnostics and therapeutics: From extracellular vesicles to precision medicine

Extracellular vesicles (EVs) are membrane-bound vesicles released by various cell types and contain biologically active molecules that participate in key physiological and pathological processes. EVs play crucial roles in intercellular communication, immune regulation, tissue repair, and disease progression, particularly in cancer, neurodegenerative disorders, and cardiovascular conditions. Because of their structural stability and ability to evade immune detection, EVs are potential noninvasive biomarkers and therapeutic delivery vehicles. Advances in isolation and purification techniques have further supported their application in precision medicine, with research indicating EVs provide insight into disease mechanisms and therapeutic responses. EVs also facilitate the transfer of nucleic acids, proteins, and lipids between cells, thereby modulating gene expression and cellular activities. Their emerging role as biomarkers for diagnosis and outcome prediction, especially in cancer and neurodegenerative diseases, are areas of active investigation. Despite these promising applications, several challenges hinder clinical translation, including difficulties in distinguishing disease-derived EVs from normal EVs, the absence of standardized therapeutic protocols, the possibility of oncogenic cargo, high production costs, and variability in immune responses. Addressing these challenges by developing improved isolation techniques, standardized evaluation protocols, and cost-effective production strategies and continuing to conduct research is essential to fully realizing the diagnostic and therapeutic potential of EVs in precision medicine. Extracellular vesicles (EVs) are membrane-bound vesicles released by various cell types and contain biologically active molecules that participate in key physiological and pathological processes. EVs play crucial roles in intercellular communication, immune regulation, tissue repair, and disease progression, particularly in cancer, neurodegenerative disorders, and cardiovascular conditions. Because of their structural stability and ability to evade immune detection, EVs are potential noninvasive biomarkers and therapeutic delivery vehicles. Advances in isolation and purification techniques have further supported their application in precision medicine, with research indicating EVs provide insight into disease mechanisms and therapeutic responses. EVs also facilitate the transfer of nucleic acids, proteins, and lipids between cells, thereby modulating gene expression and cellular activities. Their emerging role as biomarkers for diagnosis and outcome prediction, especially in cancer and neurodegenerative diseases, are areas of active investigation. Despite these promising applications, several challenges hinder clinical translation, including difficulties in distinguishing disease-derived EVs from normal EVs, the absence of standardized therapeutic protocols, the possibility of oncogenic cargo, high production costs, and variability in immune responses. Addressing these challenges by developing improved isolation techniques, standardized evaluation protocols, and cost-effective production strategies and continuing to conduct research is essential to fully realizing the diagnostic and therapeutic potential of EVs in precision medicine. Lay Summary: Extracellular vehicles (EVs) are tiny particles released by cells that transport important biological messages. These vesicles, once dismissed as cellular debris, are now recognized for their crucial roles in immune function, tissue repair, and disease progression. Because EVs are stable and circulate in body fluids like blood, they hold great potential as non-invasive biomarkers for disease detection and as natural carriers for drug delivery. Scientists are exploring how EVs could improve early disease detection and precision medicine, tailoring treatments to individual patients. However, challenges remain, including refining EV isolation techniques and ensuring their safe and effective use in therapy. Despite these hurdles, EVs offer exciting possibilities for revolutionizing healthcare by enabling earlier disease detection, improved monitoring, and more effective targeted treatments. Copyright © 2025, the Chinese Medical Association.