Detection of Colorectal Cancer Using a Simplified SEPT9 Gene Methylation Assay Is a Reliable Method for Opportunistic Screening

被引:111
作者
Wu, Dong [1 ]
Zhou, Guangpeng [2 ]
Jin, Peng [3 ]
Zhu, Jiqing [4 ]
Li, Shijie [5 ]
Wu, Qi [5 ]
Wang, Guiqi [4 ]
Sheng, Jianqiu [3 ]
Wang, Jianming [2 ]
Song, Lele [2 ]
Han, Xiaoliang [2 ]
Qian, Jiaming [1 ]
机构
[1] Chinese Acad Med Sci, Peking Union Med Coll Hosp, Translat Med Ctr, Dept Gastroenterol, 1 Shuaifuyuan, Beijing 100730, Peoples R China
[2] BioChain Beijing Sci & Technol Inc, Beijing, Peoples R China
[3] Beijing Mil Gen Hosp, Dept Gastroenterol, Beijing, Peoples R China
[4] Chinese Acad Med Sci, Canc Inst & Hosp, Dept Endoscopy, Beijing, Peoples R China
[5] Beijing Univ, Canc Hosp & Inst, Dept Endoscopy, Beijing, Peoples R China
关键词
FECAL-OCCULT-BLOOD; STOOL DNA TEST; TASK-FORCE; PLASMA; BIOMARKER; PERFORMANCE; MORTALITY; ADENOMAS; MARKERS; TESTS;
D O I
10.1016/j.jmoldx.2016.02.005
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
SEPT9 gene methylation was validated as a biomarker for colorectal cancer (CRC) for >10 years and available as the Epi proColon test as an aid in CRC detection for >6 years. It was proven to be an accurate, reliable, fast, and convenient molecular test. In this opportunistic screening study, we validated a further simplified SEPT9 gene methylation assay in 1031 subjects in Chinese hospitals. The sensitivity for CRC detection was 76.6% at a specificity of 95.9%, and the results showed a satisfactory detection rate for each CRC stage, including early stages. The new SEPT9 assay, with enhanced technical simplicity, convenience, and lower cost, did not differ in performance compared with Epi proColon 2.0, the commercialized SEPT9 assay. The CRC detection sensitivity was further enhanced when the assay was combined with carcinoembryonic antigen (sensitivity, 86.4%) or fecal immunochemical test (sensitivity, 94.4%), suggesting that the combined tests may be an effective option for future opportunistic screening. In brief, our study has validated a new SEPT9 assay and combined testing as an aid in cancer detection, providing a new approach for opportunistic CRC screening.
引用
收藏
页码:535 / 545
页数:11
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