细胞外囊泡（EV）是纳米级颗粒，具有在临床领域中具有巨大潜力的特点，因为它们的生物分子特征对于癌症诊断和预后的非侵入性液态活检至关重要。EV存在于大多数体液中，因此可以轻松从患者中获得，相较于传统的侵入性组织活检和影像技术具有优势。然而，某些限制阻碍了EV的临床使用。由于目前实验室实施的EV分离和随后的生物标志物检测方法存在局限性，因此从“台架到床边”的EV生物标志物翻译受到阻碍。尽管当前的分离和检测方法是有效的，但它们缺乏实用性，需要高体液容量、设备不易获得、回报时间慢和成本高。对于克服这些限制的技术的高需求已经导致了纳米技术设备的显著进步。这些设备被设计为将EV的分离和生物标志物检测整合到直接从体液中检测EV的一步方法中。这为将EV加速成为当前临床标准提供了希望。本综述强调了EV作为癌症生物标志物的重要性，当前临床研究面临的方法学障碍以及新型纳米设备如何推进临床转化。版权所有©2023 Elsevier Ltd.

Extracellular vesicles (EVs) are nano-sized particles that hold tremendous potential in the clinical space, as their biomolecular profiles hold a key to non-invasive liquid biopsy for cancer diagnosis and prognosis. EVs are present in most bodily fluids, hence are easily obtainable from patients, advantageous to that of traditional, invasive tissue biopsies and imaging techniques. However, there are certain constraints that hinder clinical use of EVs. The translation of EV biomarkers from "bench-to-bedside" is encumbered by the methods of EV isolation and subsequent biomarker detection currently implemented in laboratories. Although current isolation and detection methods are effective, they lack practicality, with their requirement for high bodily fluid volumes, low equipment availability, slow turnaround times and high costs. The high demand for techniques that overcome these limitations has resulted in significant advancements in nanotechnological devices. These devices are designed to integrate EV isolation and biomarker detection into a one-step method of direct EV detection from bodily fluids. This provides promise for the acceleration of EVs into current clinical standards. This review highlights the importance of EVs as cancer biomarkers, the methodological obstacles currently faced in clinical studies and how novel nanodevices could advance clinical translation.Copyright © 2023 Elsevier Ltd. All rights reserved.