The past decade has witnessed a rapid growth in the field of extracellular vesicle (EV) based biomarkers for the diagnosis and monitoring of cancer. Several studies have reported novel EV based biomarkers, but the technical and clinical validation phase has been hampered by general challenges common to biomedical research field as well as specific challenges inherent to the nanoparticle field. This has led to more common failures than success stories in the biomarker discovery pipeline. As a result, more attention must be focused on the process of biomarker discovery, verification, and validation to allow for translation and application of novel EV based research to patient care. Herein, we briefly discuss the hurdles and potential solutions in EV biomarker discovery and verification and validation, and clinical translation.

中文翻译：

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从实验室到临床：基于细胞外囊泡的癌症生物标志物的翻译

过去十年见证了基于细胞外囊泡 (EV) 的用于癌症诊断和监测的生物标志物领域的快速增长。几项研究报告了基于 EV 的新型生物标志物，但技术和临床验证阶段受到生物医学研究领域常见的普遍挑战以及纳米粒子领域固有的特定挑战的阻碍。在生物标志物发现管道中，这导致了比成功案例更常见的失败。因此，必须更多地关注生物标志物的发现、验证和验证过程，以便将基于 EV 的新型研究转化和应用到患者护理中。在此，我们简要讨论了 EV 生物标志物发现、验证和验证以及临床转化中的障碍和潜在解决方案。