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How Accurate is Epi proColon® 2.0 CE?

Epi proColon® 2.0 CE finds cancer in about 8 out of 10 (81%) people with the disease. Epi proColon® 2.0 CE also has positive results in people who do not have cancer. These are called false-positive results. Positive results were found in about 3 out of 100 (3%) people who do not have cancer.

 

Epi proColon® 2.0 CE was studied for accuracy in a clinical trial:

From an average-risk screening population, prospectively collected blood samples from 149 healthy people were enrolled to evaluate the clinical performance of Epi proColon 2.0 CE. Additionally, 197 blood samples from 99 healthy people and 98 colorectal carcinoma patients
(all stages) were collected and evaluated.

 

Epi proColon Sensitivity = 81% Epi proColon False-Positive Rate = 3% Negative Predictive Value (NPV) = 99.9% Positive Predictive Value
(PPV)=11,9%-28,9%
This means that the blood test was positive in about 8 out of 10 people with colorectal cancer. blood test was positive in about 3 out of 100 people who did not have colorectal cancer. This means that a person with a negative result has a very low chance of having colorectal cancer.
This means a person with a positive test has a 11,9%-28,9% chance of having colorectal cancer.
People Not Tested in Study One
  • People at higher-risk for colorectal cancer*
  • People with rectal bleeding or fresh blood in the stool

PPV = percent chance that a person with a positive test result has colorectal cancer
NPV = percent chance that a person with a negative test result does not have colorectal cancer

*A person is considered average-risk for colorectal cancer, if none of the following criteria are met:

A close family member  (parent, sibling, child) has had colorectal cancer. The risk is higher when two or more family members have had colorectal cancer. It is also higher if one or more family members has colorectal cancer and is less than age 50.
A history of benign polyps in the colon or rectum or related cancers, or other bowel disease like inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC), or Crohn’s disease.
A history of benign polyps in the colon or rectum or related cancers, or other bowel disease like inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC), or Crohn’s disease.
The presence of inherited diseases like Lynch syndrome (hereditary non-polyposis colorectal cancer) or FAP (familial adenomatous polyposis)
The presence of other inherited diseases include Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis.