Prospective clinical validation of an assay for methylated SEPT9 DNA for use in detection of colorectal cancer in human plasma from average risk men and women over the age of 50

Aims: A suitably sensitive and specific blood-based test for colorectal cancer (CRC) could appreciably increase the number of guideline eligible average risk individuals screened due to increased convenience and safety compared to other screening methods. Two previous case-control studies of clinically confirmed CRC demonstrated that detection of methylated SEPT9 DNA (mSEPT9) in plasma indicated the presence of CRC. The purpose of the study was to assess sensitivity and specificity of mSEPT9 in a screening cohort. Methods: With ethics board approvals, subjects, 50 years or older, scheduled for screening colonosc…