The SEPT9 gene methylation assay is capable of detecting colorectal adenoma in opportunistic screening

Abstract

Aim: This study validated the detection of colorectal adenoma in opportunistic screening using the SEPT9 gene methylation assay. Materials & methods: Plasma samples including 85 colorectal cancers, 364 adenomas, 216 hyperplastic polyps, 372 other gastrointestinal diseases and 324 normal subjects, were obtained and tested using the Epi proColon 2.0 CE assay. Results & conclusion: The SEPT9 assay detected 38.7% of all types of adenoma, including 27.8% of serrated adenoma, 28.7% of tubular adenoma, 53.7% of tubulovillous adenoma and 83.3% of villous adenoma. It also detected 27.5% of nonadvanced adenoma (NAA), 47.0% of advanced adenoma (AA) without high-grade dysplasia and 62.5% of AA with high-grade dysplasia. The average adenoma detection rate was 31.8% (95% CI: 28.3–35.4%) with the Boston Bowel Preparation Scale score at 7.6 ± 1.2 (mean ± SD). Our study provided strong evidence for the application of the SEPT9 assay in AA detection in opportunistic screening.

Keywords::

• adenoma
• colorectal cancer
• dysplasia
• FIT
• methylation
• screening
• SEPT9
• septin 9
• stool DNA

Acknowledgements

We thank Y Li and W Xiao for support, advice and organizing the clinical study.

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/3dp-2022-0019

Financial & competing interests disclosure

This study was supported by the Beijing Municipal Science and Technology Project (capital public health project) No. Z151100003915092 sponsored by the Beijing Municipal Science and Technology Commission. L Song, G Zhou and X Han are current employees of BioChain (Beijing, China) Science and Technology, Inc. BioChain is a collaborator of Epigenomics AG, a Germany-based company that launched the first commercial SEPT9 assay. This does not alter our adherence to all the policies of Epigenomics on sharing data and materials. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The plan for the study was submitted to the ethics committee of the participating hospitals for review and approval before the start of the clinical study. All subjects signed the informed consent before blood collection, and they were informed of the usage of plasma and the test results. Confirmation of approval for clinical studies was received from all named institutional review board or ethics committee.

Additional information

Funding

This study was supported by the Beijing Municipal Science and Technology Project (capital public health project) No. Z151100003915092 sponsored by the Beijing Municipal Science and Technology Commission. L Song, G Zhou and X Han are current employees of BioChain (Beijing, China) Science and Technology, Inc. BioChain is a collaborator of Epigenomics AG, a Germany-based company that launched the first commercial SEPT9 assay. This does not alter our adherence to all the policies of Epigenomics on sharing data and materials. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.