The Quantitative Profiling of Blood mSEPT9 Determines the Detection Performance on Colorectal Tumors

Abstract

Aim: To investigate the quantitative relationship between the positive detection rate (PDR) in colorectal tumor detection and the mSEPT9 level. Materials & methods: The level of blood mSEPT9 in various colorectal diseases was quantified by the Epi proColon 2.0 assay. ΔΔCt values were calculated representing the mSEPT9 level. A total of 1347 subjects were recruited in this quantitative study. Results: PDR or sensitivity was positively correlated with the progression of colorectal tumors and the mSEPT9 level in an exponential relationship. The mSEPT9 level of CRC exhibited a distinct pattern of distribution. Strong correlation was found between mSEPT9 level and PDR or sensitivity in various tumor differentiation, pathological types or metastasis. Conclusion: The quantitative profiling of blood mSEPT9 determines the detection performance on colorectal tumors.

Keywords::

• adenoma
• colorectal cancer
• ctDNA
• methylation
• polyps
• sensitivity
• SEPT9
• septin 9
• specificity

Acknowledgements

This study was funded by the Beijing Municipal Science and Technology Project (Capital Public Health Project) No. Z151100003915092 sponsored by the Beijing Municipal Science and Technology Commission.

Financial & competing interests disclosure

L Song was an employee 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. 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 detailed plan for the study was submitted to the ethics committee of the participating hospitals for review and was approved before the initiation of the clinical study. All subjects involved in the study 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.