The following is an overview of the three clinical validation trials that support the Epi proColon FDA Premarket approval. Within these trials – there is a head-to-head comparison to colonoscopy (trial one), to FIT (trial two), and behavioral acceptance of a blood test (trial three). For extensive trial detail, please see Appendix iii.
The first study compared the accuracy of Epi proColon to colonoscopy in 1,544 samples from men and women, 50-85 years of age who were of average-risk for CRC. Epi proColon was positive in 7 out of 10 people with CRC and in 2 out of 10 people without CRC.