生物传感器转化的整体途径

IF 3.5 Q2 CHEMISTRY, ANALYTICAL
Laena D'Alton, Dênio Emanuel Pires Souto, Chamindie Punyadeera, Brian Abbey, Nicolas H. Voelcker, Conor Hogan and Saimon M. Silva
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引用次数: 0

摘要

护理点(POC)生物传感器具有巨大的潜力,可在患者所在地帮助指导和告知临床决策。它们尤其适用于服务不足的人群和生活在偏远地区的人们,因为那里的医疗基础设施和资源往往有限。在许多研究领域,将有效的 POC 生物传感器转化为商业产品的工作正在迅速发展。每年都有大量关于生物传感的基础、应用和概念验证方面的科学文章被报道。然而,市场上商业生物传感器的数量相对较少,这并没有反映出大量的研究成果。在此,我们将讨论生物传感器转化过程中的关键环节,包括各种体液中分析生物标记物的选择、临床试验、监管审批、消费者参与、生产和扩大规模策略、卫生经济学以及法律和伦理方面的考虑。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A holistic pathway to biosensor translation

A holistic pathway to biosensor translation

A holistic pathway to biosensor translation

Point-of-care (POC) biosensors have enormous potential to help guide and inform clinical decisions at a patient's location. They are particularly relevant to underserved populations, and people living in remote locations where healthcare infrastructure and resources are often limited. The translation of effective POC biosensors into commercial products is rapidly growing across many research fields. A significant quantity of scientific articles focused on the fundamental, applied, and proof-of-concept aspects of biosensing are reported each year. However, this extensive body of work is not reflected in the comparatively small number of commercial biosensors available on the market. Here, we discuss key aspects of the biosensor translation process including the selection of analytical biomarkers in various body fluids, clinical trials, regulatory approval, consumer engagement, manufacturing and scale-up strategies, health economics, and legal and ethical considerations.

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