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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.

Adherence