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 Clinical Trials Summary

The following is an overview of the three clinical validation trials that support the Epi proColon FDA Premarket approval. Within these trials – there is a head-to-head comparison to colonoscopy (trial one), to FIT (trial two), and behavioral acceptance of a blood test (trial three).

Trial One (Comparison vs. Colonoscopy)

The first study compared the accuracy of Epi proColon to colonoscopy in 1,544 samples from prospectively enrolled men and women, 50-85 years of age who were of average-risk for CRC. Epi proColon was positive in 7 out of 10 people with CRC and in 2 out of 10 people without CRC.

Sensitivity (95% CI) Specificity (95% CI)
68.2%

(53.4-80.0)

80.0%

(77.9-82.1)*

Negative Predictive Value (95% CI) Positive Predictive Value (95% CI)
99.7%

(99.6-99.8)

2.4%

(2.0-3.0)

Notable Observations
  • All subjects prospectively enrolled
  • Asymptomatic, Average-risk screening population
  • All blood samples were collected prior to bowel prep
  • Identified CRC in all cancer stages and throughout the colon and rectum.

*Weighted to the Trial One population

 

Trial Two (Comparison vs. FIT)

The second study compared the accuracy of Epi proColon to a fecal immunochemical test (FIT) using matched blood and stool samples form 290 people. Epi proColon was found to be statistically non-inferior to FIT with respect to sensitivity but not specificity. Epi proColon was positive in 7 out of 10 people with CRC and in 2 out of 10 people without CRC. FIT was positive in 7 out of 10 people with CRC and less than 1 out of 10 with CRC.

NOTE: Assumes a prevalence of 0.7% based on Study One for Positive and Negative Predictive Values with 95% CI. Predictive values inform how likely disease is given the test result. PPV indicates how likely disease is given a positive test result. NPV indicates how likely absence of disease is given a negative test result.

Epi proColon (95% CI) (n=290)
Sensitivity 72.2% (62.5-80.1) Specificity 80.8% (74.7-85.8) NPV 99.8% (99.7-99.8)

PPV 2.7% (2.0-3.7)

FIT (95% CI) (n=290)
Sensitivity 68.0% (58.2-76.5) Specificity 97.4%

(94.1-98.9)

NPV 99.8% (99.7-99.8)

PPV 15.6% (7.2-30.8)

Notable Observations
  • Epi proColon detects CRC as well as FIT
  • Identified CRC in all cancer stages and throughout the colon and rectum.

 

 

 

 

 

 

 

 

 

Trial Three (Adherence Study)

The third study compared participation in CRC screening among 413 people who were offered either a stool or a blood test. All people in the study had at least two screening recommendations in the past and were not up-to-date with their screening.

Epi proColon FIT
  • 203 people were offered the blood test for CRC screening and 202 completed it (99.5%)
  • 30 people had a positive Epi proColon result; of those, 10/17 or 58.8% who completed a colonoscopy had a polyp, polypoid or adenoma removed
  • 210 people were offered the stool test for CRC screening and 185 completed it (88.1%)
  • 3 people had a positive FIT result; of those, one  completed a colonoscopy and had a polyp removed