ColoVantage is a new test available from Quest. It is a screening test that is not meant to be a substitute for colonoscopy. It was approved by NY State in March of 2011. It detects circulating methylated DNA from the SEPT9 gene, which is involved in cytokinesis and cell cycle control. A case-control study performed at Quest Diagnostics showed that the ColoVantage test is 70% sensitive for CRC detection at a specificity of 89%. ColoVantage has successfully detected cancer at all stages; however, the number of patients at each stage of cancer was too small to derive stage-specific sensitivity data. A similar test demonstrated a sensitivity of 67% and a specificity of 88% in a prospective study of almost 8000 people. Unfortinately, at this time, it remains a proprietary test that has not been sufficiently studied. These findings need to be confirmed in larger studies that evaluate the clinical utility of this test. Support for this test in guidelines from professional organizations is lacking.
Rösch T, Church T, Osborn N, et al. Prospective clinical validation of an assay for methylated SEPT9 DNA for colorectal cancer screening in plasma of average risk men and women over the age of 50 [abstract]. Gut. 2010;59(suppl III):A307.
deVos T, Tetzner R, Model F, Weiss G, Schuster M, Distler J, et al. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer. Clin Chem. 2009 Jul;55(7):1337-46.
Tänzer M, Balluff B, Distler J, Hale K, Leodolter A, Röcken C, et al. Performance of epigenetic markers SEPT9 and ALX4 in plasma for detection of colorectal precancerous lesions. PLoS One. 2010 Feb 4;5(2):e9061.
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