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尿路EV生物标志物的障碍:向临床转移

Marvin Droste¹, Maija Puhka², Martin E van Royen³

¹Department II of Internal Medicine, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.

Journal of extracellular vesicles

|July 17, 2025

概括

尿液细胞外囊泡 (uEVs) 的临床翻译面临着挑战,尽管它们具有生物标志物潜力. 本次审查确定了障碍,并提出了成功开发UEV生物标志物和获得监管批准的解决方案.

科学领域:

生物标志物发现发现
细胞外囊泡细胞外囊泡
临床翻译临床翻译

背景情况:

尿液细胞外囊泡 (UEV) 显示出作为生物标志物的前景.
对UEV生物标志物的临床翻译面临重大障碍.
需要系统地考虑路障,才能取得进展.

研究的目的:

确定尿动EV基生物标志物的临床转化中的关键障碍.
讨论克服这些挑战的潜在解决方案.
为推进该领域提供路线图.

主要方法:

对现有文献进行系统审查.
将障碍分类为基本,技术,测试开发,临床接受和监管障碍.
讨论协作方法和早期考虑发展障碍.

主要成果:

确定了多个基本和技术障碍.
突出了生物标志物测试开发和临床接受方面的挑战.
讨论了UEV生物标志物的监管批准过程中的障碍.

结论:

通过协调努力,可以实现UEV生物标志物的临床转化.
促进严谨性,可重复性和协作是至关重要的.
早期考虑测试开发和监管要求最大限度地提高了翻译的成功.

关键词:

生物标志物生物标志物膀膀膀膀是一个外基因组是外基因组的组成部分.细胞外囊泡中的细胞外囊泡.脏脏脏是什么?液体活检活检液体活检前列腺前列腺前列腺翻译翻译翻译翻译翻译翻译尿液尿液尿液

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