FDA Approves First-ever Blood Test for Colon Cancer Screening, Despite Split Opinion

Epi proColon, the first-ever blood screening test for colon cancer, received U.S. Food and Drug Administration (FDA) approval for average-risk patients over age 50 years—2 years after a divided advisory panel recommended the approval.¹

Although colonoscopy remains the gold standard for screening in the United States, Robert Smith, PhD, vice president for cancer screening at the American Cancer Society (ACS) in Atlanta, GA, told Cancer Therapy Advisor that 40% to 50% of eligible individuals are “standoffish” about undergoing this procedure every 10 years, as recommended by the ACS, the US Preventive Services Task Force, and other organizations. Some of these individuals opt instead for an annual stool test—either the fecal immunochemical test (FIT) or the guaiac fecal occult blood test—despite the “yuck” factor.²

By incorporating the Epi proColon blood test into the practice setting, Dr Smith said, “it might get another 10% of people screened.” Whether or not that happens could be reflected in Germany-based Epigenomics AG’s planned post-marketing studies for its blood test over the next 6 months, as required by the FDA.

Already available in Europe and China, Epi proColon uses polymerase chain reaction technology to pick up methylation status of the Septin 9 tumor marker. Methylated Septin 9 is part of a family of tumor suppressor genes that circulate in the blood of some patients with colon cancer. However, it is also found in the blood of some patients with chronic gastritis and lung cancer and even pregnant women, the FDA said.³

This lack of specificity around Septin 9, which can lead to false-positive test results,⁴ raised concern among some physicians. And major cancer organizations, including the ACS, plan to conduct their own evaluations before recommending Epi proColon be added to the small group of colon cancer screening tools available.