Epigenomics has released additional results from the comparative study aimed to know non-inferiority of Epi proColon assay performance in comparison to fecal immunochemical testing (FIT).
The additional data had shown that Epi proColon was able to demonstrate 61% sensitivity for 23 cases in stages 0 and 1 , 75% for 16 cases in stage 2 , 70% for 20 cases in stage 3 and 92% in 12 stage 4 cases, while 32 cases of unknown clinical staging reported a sensitivity of 69%.
During the study, Epi proColon was able to identify 20 cases, which could not be identified by FIT, while FIT identified 17 CRC cases, which were not found through Epi proColon.
The second arm of the study included 198 average risk individuals, who were prospectively enrolled before colonoscopy.
The overall specificities reported for FIT were 98%, while Epi proColon reported 81%, which was above the pre-defined non-inferiority margin estimate.
In the previously reported study, Epi proColon was able to detect 73 out of 103 cancer cases, demonstrating an overall sensitivity of 71%.
