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A serum test for the methylated SEPT9 gene (mSEPT9) is the first serum marker to be tested for colorectal cancer screening in a major trial. In the industry-funded study, investigators prospectively assessed the performance of mSEPT9 to detect colorectal cancer in 7941 participants (45% men; mean age, 60 years) undergoing screening colonoscopy in multiple centers in the U.S. and Germany.
Results included the following:
Colorectal cancers diagnosed included: invasive cancer (53), advanced adenoma (315), and high-grade dysplasia (54).
Overall sensitivity for cancer was 48.2%; overall specificity was 91.5%.
Overall positive predictive value for cancer was 5.2%; overall negative predictive value was 99.5%.
By cancer stage, sensitivity was 35% for st…