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J Mol Diagn. 2016 Jul;18(4):535-45. doi: 10.1016/j.jmoldx.2016.02.005. Epub 2016 Apr 28.

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

Author information

1
Department of Gastroenterology, Translational Medicine Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
2
BioChain (Beijing) Science and Technology, Inc., Beijing, People's Republic of China.
3
Department of Gastroenterology, Beijing Military General Hospital, Beijing, People's Republic of China.
4
Department of Endoscopy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
5
Department of Endoscopy, Beijing University Cancer Hospital and Institute, Beijing, People's Republic of China.
6
BioChain (Beijing) Science and Technology, Inc., Beijing, People's Republic of China. Electronic address: shan@biochain.com.
7
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.

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.

PMID:
27133379
DOI:
10.1016/j.jmoldx.2016.02.005
[Indexed for MEDLINE]

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