Epi proColon: Clinical trial data
The U.S. ADMIT trial in 413 average-risk patients ages 50-76 who have been historically non-compliant to colorectal cancer screening according to screening guidelines showed a 99.5% rate of adherence to colorectal cancer screening using Epigenomics’ Epi proColon test vs. an 88.1% rate of adherence for fecal immunochemical test (FIT). The trial was designed to determine whether adherence to Epi proColon was significantly greater to FIT plus a margin of 8.2%, which did not reach statistical significance (p=0.059). Given the difference in the observed FIT adherence rate in ADMIT from the projected FIT adherence rate, Epigenomics said that demonstrating an adherence to Epi proColon equaling the FIT adherence rate plus a margin of 3.2% would have been sufficient to prove superiority. In that scenario, the 11.4% difference in adherence met statistical significance (p<0.0001). ...