Colorectal Cancer Screening

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The page below is a sample from the LabCE course Epigenetics: Diagnostic Methods in the Clinical Laboratory. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Colorectal Cancer Screening

The first FDA-approved blood test for colorectal cancer screening is Epi proColon® 2.0 CE. It is a molecular test that detects methylated Septin9 DNA in the blood. DNA methylation of the SEPT9 gene is increased in colorectal cancer.25
Methylated SEPT9 tumor DNA is shed into the bloodstream and displays a unique methylation pattern that is detectable in plasma by Real-Time PCR.25
When compared to Fecal Immunochemical Testing (FIT), the Epi proColon was found to be more sensitive but not as specific. The statistics are listed below for the Epi proColon. Both tests identified similar numbers of patients with colorectal cancer and identified the cancer in all stages throughout the colon and rectum.26
  • Sensitivity ~72.2%
  • Specificity ~80.8%
Epi proColon test workflow. (25)
25. "Epigenomics Annual Report 2019." Epigenomics AG. Available at: https://www.epigenomics.com/wp-content/uploads/2020/04/EPI_E_AR2019_sec.pdf.
26. "Epi proColon." Epigenomics AG, 2017. Available at: https://www.epiprocolon.com/wp-content/uploads/sites/3/2017/06/MKT_0026_Physician_messaging_and_brochure_rev5.pdf.