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

doi:magtech.2025.06.30-00003

Abstract

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

CLC Number:

R730.49

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

Clinical Scenarios and Key Points of Clinical Evaluation for Biomarker Detection in Cancer Screening [J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2025, 27(11): 1127-1127-1132.

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

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