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|
|Epi proColon 2.0 CE Positive||1||3||79|
|Epi proColon 2.0 CE Negative||148||96||19|
(95% CI, 96-100)
(95% CI, 91-99)
(95% CI, 72-87)
|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
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.