Clinical Trials Summary
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).
Trial One (Comparison vs. Colonoscopy)
The first study compared the accuracy of Epi proColon to colonoscopy in 1,544 samples from prospectively enrolled 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.
| Sensitivity (95% CI) | Specificity (95% CI) |
| 68.2%
(53.4-80.0) |
80.0%
(77.9-82.1)* |
| Negative Predictive Value (95% CI) | Positive Predictive Value (95% CI) |
| 99.7%
(99.6-99.8) |
2.4%
(2.0-3.0) |
| Notable Observations |
|
*Weighted to the Trial One population
Trial Two (Comparison vs. FIT)
The second study compared the accuracy of Epi proColon to a fecal immunochemical test (FIT) using matched blood and stool samples form 290 people. Epi proColon was found to be statistically non-inferior to FIT with respect to sensitivity but not specificity. Epi proColon was positive in 7 out of 10 people with CRC and in 2 out of 10 people without CRC. FIT was positive in 7 out of 10 people with CRC and less than 1 out of 10 with CRC.
NOTE: Assumes a prevalence of 0.7% based on Study One for Positive and Negative Predictive Values with 95% CI. Predictive values inform how likely disease is given the test result. PPV indicates how likely disease is given a positive test result. NPV indicates how likely absence of disease is given a negative test result.
| Epi proColon (95% CI) (n=290) | ||
| Sensitivity 72.2% (62.5-80.1) | Specificity 80.8% (74.7-85.8) | NPV 99.8% (99.7-99.8)
PPV 2.7% (2.0-3.7) |
| FIT (95% CI) (n=290) | ||
| Sensitivity 68.0% (58.2-76.5) | Specificity 97.4%
(94.1-98.9) |
NPV 99.8% (99.7-99.8)
PPV 15.6% (7.2-30.8) |
| Notable Observations |
|
Trial Three (Adherence Study)
The third study compared participation in CRC screening among 413 people who were offered either a stool or a blood test. All people in the study had at least two screening recommendations in the past and were not up-to-date with their screening.
| Epi proColon | FIT |
|
|