Clinical Performance
From an average-risk screening population, prospectively collected clinical samples from 149 patients with no evidence of disease (NED) were enrolled to evaluate the clinical performance of Epi proColon 2.0 CE. Additionally, in a case-control design, 197 clinical samples from 99 colonoscopy-verified negative NED patients and 98 histologically-confirmed colorectal carcinoma patients
(all CRC* stages) were collected and evaluated.
| Screening Cohort | Case-Control Cohort | CRC Cases | |
| Results | 149 | 99 | 98 |
| Epi proColon 2.0 CE Positive | 1 | 3 | 79 |
| Epi proColon 2.0 CE Negative | 148 | 96 | 19 |
| Specificity | 99,3% (95% CI, 96-100) |
96,9% (95% CI, 91-99) |
N/A |
| Sensitivity | N/A | N/A | 80,6% (95% CI, 72-87) |
| NPV | 99,9% | 99,9% | N/A |
| PPV | 28,9% | 11,9% | N/A |
| Additional Information |
| NPV and PPV were calculated with a presumed prevalence of 0,5% for CRC in the average-risk population. PPV (Positive Predictive Value) = percent probability that a person with a positive test result has CRC NPV (Negative Predictive Value) = percent probability that a person with a negative test result does not have CRC |
*CRC = Colorectal Cancer
Adherence
In a CRC screening adherence study, 172 people eligible for CRC screening were enrolled and advised to undergo screening by colonoscopy. People unwilling to be screened by colonoscopy were subsequently offered non-invasive blood and stool test options for screening. Of the 109 (63%) people refusing screening colonoscopy, 90 (83%) chose the blood test and 16 (15%), the stool test. This study highlights the importance of offering a non-invasive blood test alternative to increase the acceptance of CRC screening in non-adherent patients, Figure 1.
