title: Detection of Colorectal Cancer Using a Simplified SEPT9 Gene Methylation Assay Is a Reliable Method for Opportunistic Screening.
abstract: 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.
authors.affiliation: Department of Gastroenterology, Translational Medicine Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
authors.forename: Dong
authors.initials: D
authors.lastname: Wu
authors.affiliation: BioChain (Beijing) Science and Technology, Inc., Beijing, People's Republic of China.
authors.forename: Guangpeng
authors.initials: G
authors.lastname: Zhou
authors.affiliation: Department of Gastroenterology, Beijing Military General Hospital, Beijing, People's Republic of China.
authors.forename: Peng
authors.initials: P
authors.lastname: Jin
authors.affiliation: Department of Endoscopy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
authors.forename: Jiqing
authors.initials: J
authors.lastname: Zhu
authors.affiliation: Department of Endoscopy, Beijing University Cancer Hospital and Institute, Beijing, People's Republic of China.
authors.forename: Shijie
authors.initials: S
authors.lastname: Li
authors.affiliation: Department of Endoscopy, Beijing University Cancer Hospital and Institute, Beijing, People's Republic of China.
authors.forename: Qi
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Endoscopy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
authors.forename: Guiqi
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, Beijing Military General Hospital, Beijing, People's Republic of China.
authors.forename: Jianqiu
authors.initials: J
authors.lastname: Sheng
authors.affiliation: BioChain (Beijing) Science and Technology, Inc., Beijing, People's Republic of China.
authors.forename: Jianming
authors.initials: J
authors.lastname: Wang
authors.affiliation: BioChain (Beijing) Science and Technology, Inc., Beijing, People's Republic of China.
authors.forename: Lele
authors.initials: L
authors.lastname: Song
authors.affiliation: BioChain (Beijing) Science and Technology, Inc., Beijing, People's Republic of China. Electronic address: shan@biochain.com.
authors.forename: Xiaoliang
authors.initials: X
authors.lastname: Han
authors.affiliation: Department of Gastroenterology, Translational Medicine Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. Electronic address: qianjiaming1957@126.com.
authors.forename: Jiaming
authors.initials: J
authors.lastname: Qian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor; D016022:Case-Control Studies; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000235:genetics*; D019175:DNA Methylation; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005820:Genetic Testing / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D058112:Septins / Q000235:genetics*
chemical_list: D014408:Biomarkers, Tumor; C474315:SEPTIN9 protein, human; D058112:Septins