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快速分散的前列腺癌风险分层通过在临床生物传感器验证框架内的便携式液体活检分析.

Kevin M Koo1,2,3, Grant Phillips2, Sriganesh Srihari4

  • 1The University of Queensland Centre for Clinical Research (UQCCR), Brisbane, QLD, Australia.

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一个新的生物传感器,AVATAR,提供快速,准确的,分散的前列腺癌 (PCa) 分子概况从尿液活检. 这项技术改善了风险分层,并有助于精确的癌症管理,克服了集中测试的局限性.

关键词:
生物标志物 生物标志物生物传感器生物传感器临床验证 临床验证液体活检活检液体活检前列腺癌是前列腺癌.

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科学领域:

  • 生物医学工程 生物医学工程
  • 分子诊断学 分子诊断学
  • 在瘤学瘤学.

背景情况:

  • 液体活检对于向癌症治疗至关重要,但目前的方法面临诸如高成本和长时间的周转等局限性.
  • 需要分散的测试来克服后勤障碍,并改善患者对分子分析的可访问性.
  • 对新兴液体活检技术进行严格的临床验证对于将其转化为临床实践至关重要.

研究的目的:

  • 报告液体活检生物传感器技术的进步,以快速,准确和分散的前列腺癌分子分析 (PCa).
  • 评估AVATAR (加速非侵入性生物分析测试和报告) 生物传感器系统的性能,用于使用尿路循环RNA生物标志物进行PCa风险分层.
  • 建立生物传感器技术用于精确癌症管理的临床转化框架.

主要方法:

  • 开发AVATAR生物传感器平台,在便携式电化学读取器上整合异热测定化学和无线移动功能.
  • 使用自定义的移动应用程序进行操作控制和在液体活检样本采集后显示结果.
  • 使用PCa临床尿样进行了独立的培训 (n=124) 和验证 (n=114) 研究,并进行了与组织转录组测序相关的后续研究 (n=39).

主要成果:

  • 与当前的临床试验相比,AVATAR生物传感器实现了较好的PCa风险分层,在培训和验证队列中AUC值分别为0.88和0.86.
  • 测试时间大幅缩短至55分钟,用于分子分析.
  • 在尿液活检和匹配的组织样本之间显示出强烈的分子生物标记相关性,支持AVATAR作为侵入性采样替代品的实用性.

结论:

  • 通过尿液活检,AVATAR生物传感器技术能够快速,准确和分散地对PCa进行分子分析.
  • 这一进步有助于改善PCa风险分层,并有可能增加临床精确的癌症管理规划.
  • 开发的框架支持生物传感器技术的临床转化,以实现可访问和高效的癌症诊断.