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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (11): 1127-1127-1132.doi: magtech.2025.06.30-00003

• 监管科学 • 上一篇    下一篇

生物标志物检测技术在恶性肿瘤筛查的临床应用及临床评价要点

何静云, 徐超, 方丽, 吕允凤   

  1. 国家药品监督管理局医疗器械技术审评中心,北京 100076
  • 收稿日期:2025-06-30 修回日期:2025-09-18 接受日期:2025-12-24 出版日期:2025-11-28 发布日期:2025-12-24
  • 基金资助:
    国家重点研发计划项目(2022YFC2409900)

Clinical Scenarios and Key Points of Clinical Evaluation for Biomarker Detection in Cancer Screening

HE Jingyun, XU Chao, FANG Li, LV Yunfeng*   

  1. Center For Medical Device Evaluation NMPA Beijing 100076, China
  • Received:2025-06-30 Revised:2025-09-18 Accepted:2025-12-24 Online:2025-11-28 Published:2025-12-24

摘要:

恶性肿瘤是严重威胁我国居民生命健康的重大公共卫生问题,恶性肿瘤的防控是健康中国行动计划的重要组成部分。早期筛查是恶性肿瘤防控的有效手段,随着分子生物学技术的发展,新型生物标志物用于恶性肿瘤筛查的研究越来越深入,并开始应用于临床实践,与超声、CT、内镜等传统筛查手段相比,更有利于改善筛查的依从性和可及性。本研究总结生物标志物检测技术用于恶性肿瘤筛查的主要临床场景和临床意义,包括直接用于宫颈癌、结直肠癌、胃癌、前列腺癌等筛查、筛查阳性结果的分流,以及用于多癌种联合筛查的探索,并从适应证和适用人群的合理确定、诊断灵敏度和特异度评价、临床获益与风险分析以及多癌种联合筛查的关注点等方面重点分析了恶性肿瘤筛查用体外诊断试剂的临床评价要点,以期为相关产品设计开发、临床试验设计以及技术审评提供参考。


关键词: 恶性肿瘤, 筛查, 生物标志物, 体外诊断试剂, 临床评价

Abstract:

Cancer poses a significant public health issue that seriously threatens the lives and health of Chinese people. Cancer prevention and control is an important part of the Healthy China Initiative. Cancer screening serves as a vital tool for cancer prevention and control. With advancements in molecular biology research on novel biomarkers for cancer screening has deepened and these biomarkers are increasingly being applied in clinical practice. Compared to traditional screening methods such as ultrasound CT and endoscopy biomarker-based approaches offer enhanced compliance and accessibility in cancer screening. This article summarizes the main clinical scenarios and clinical significance of biomarker detection in cancer screening including direct application in the screening of cervical cancer colorectal cancer gastric cancer prostate cancer etc. the triage of positive screening results and the exploration in multiple cancer detection and also the article provides a detailed analysis of the key aspects of clinical evaluation for in vitro diagnostic reagents used in cancer screening such as the reasonable determination of indications and applicable populations the evaluation of sensitivity and specificity the analysis of clinical benefits and risks and the focus points of multiple cancer detection. This article aims to provide references for the design and development clinical trial design and technical review of related products.


Key words:  , Cancer , Screening , Biomarker , In vitro diagnostic reagents , Clinical evaluation

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