Patients

Get Screened

How Accurate is Epi proColon®?

Epi proColon® finds cancer in about 7 out of 10 (70%) people with the disease. Epi proColon also has positive results in people who do not have cancer. These are called false-positive results. Positive results were found in about 2 out of 10 (20%) people who do not have cancer.

Epi proColon was studied for accuracy in three studies:

Study One

The first study compared Epi proColon to colonoscopy. The study included 1,544 men and women, age 50 to 85 years who were average-risk for colorectal cancer. The study was conducted at 32 sites in the United States and Germany.

Epi proColon Sensitivity = 68.2% Epi proColon False-Positive Rate = 20.0% Negative Predictive Value (NPV) = 99.7% Positive Predictive Value
(PPV)=2.4%
This means that the blood test was positive in about 7 out of 10 people with colorectal cancer. This means that the blood test was positive in about 2 out of 10 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 2.4% chance of having colorectal cancer.

40-1

People Not Tested in Study One
  • People at higher-risk for colorectal cancer
  • People with rectal bleeding or fresh blood in the stool
  • People with a known history of iron deficiency

1 Person with a positive result; 1-1 Person with a positive result with colorectal cancer
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

 

Study Two

The second study compared Epi proColon to a FIT stool test at 61 sites in the United States. This study included 290 people. Each person gave a blood and  stool sample. In this study, both tests found colorectal cancer at all cancer stages. Also, both tests found cancer in different places throughout the colon and rectum.

Epi proColon Test

Epi proColon Sensitivity = 72.2% Epi proColon
False-Positive Rate = 19.2%
Negative Predictive Value (NPV) = 99.8% Positive Predictive Value
(PPV) = 2.7%
This means that the blood test was positive in about 7 out of 10 people with colorectal cancer. This means that the blood test was positive in about 2 out of 10 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 2.7% chance of having colorectal cancer.

37-1

 

FIT Stool Test

FIT
Sensitivity = 68.0%
FIT
False-Positive Rate = 2.6%
Negative Predictive Value (NPV) = 99.8% Positive Predictive Value
(PPV)=15.6%
This means that the stool test was positive in about 7 out of 10 people with colorectal cancer. This means that the stool test was positive in less than 1 out of 10 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 15.6% chance of having colorectal cancer.

7-1

1 Person with a positive result; 1-1 Person with a positive result with colorectal cancer
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

Note: In Study One, the chance of having colorectal cancer was found to be about 0.7%. This number was used in the formula for NPV and PPV for Study Two.

 

Study Three

The third study compared the number of people that would take a blood or stool test for colorectal cancer screening. The study included 413 people at two health sites. All people in the study had been offered screening at least two times in the past and were not up-to-date.

Epi proColon FIT
  • 203 people were offered the blood test. 202 completed it (99.5%).
  • 30 people had a positive result. Of those, 17 had a colonoscopy and 10 of those had a polyp or adenoma removed.
  • 210 people were offered the stool test for colorectal cancer screening. 185 completed it (88.1%).
  • 3 people had a positive test result.  Of those, 1 had a colonoscopy and had a polyp removed.

NOTE: More information about these studies can be found at ClinicalTrials.gov. Details for Study One (NCT00855348), Study Two (NCT01580540) and Study Three (NCT02251782) may be found by looking up these study numbers.