InSure® FIT™ Performance

InSure® FIT™ is a fecal immunochemical test based upon the immunochemical detection of human hemoglobin as an indicator of blood in the stool. The assay uses a monoclonal antibody to capture human hemoglobin on a test strip during test development. In contrast to guaiac-based fecal occult blood tests, InSure® FIT™ detects the globin portion of hHb, not the heme. Since globin does not survive passage through the upper gastrointestinal (g.i.) tract, the presence of globin in the stool indicates bleeding in the colon or rectum. InSure® FIT™ possesses characteristics that differentiate it from other fecal occult blood tests:

• Simple, patient-friendly sampling replaces unpleasant fecal collection or smearing
• No dietary or medicinal restrictions
• Up to 66% more patient compliance than a guaiac-based fecal occult blood test was found in one study¹

Clinical Sensitivity and Specificity

With the InSure® FIT™ test, two samples, each from two separate bowel movements, are tested in one test card matrix. Studies have shown that testing samples from two different days results in greater sensitivity and specificity for colorectal cancer than testing a single sample or three samples, respectively.²

In a clinical trial, the InSure® FIT™ test was shown to have an 87% sensitivity for colorectal cancer.^3,4

In a study of patients who were at average risk, high risk or had no symptoms at all, the InSure® FIT™ test was found to have 33% greater sensitivity for colorectal cancer than a leading guaiac-based FOBT screening test.⁴

The InSure® FIT™ test demonstrated 98% specificity and provided accurate screening with less worry about false positives.^3,4

Greater Patient Compliance 

Screening more people for colorectal cancer will help save lives.

In one study, the InSure® FIT™ test had as much as 66% better compliance compared to a leading guaiac-based FOBT.¹

Here's why:

• No other take-home colorectal cancer screening test has this convenient, water-based collection method - if you have used a paintbrush, you can use the InSure® FIT™ test.
• The InSure® FIT™ test can be used after meals and while taking any medications. There are no special food or medication restrictions.
  
  

Powerful Colorectal Cancer Screening Tool

The key to preventing colorectal cancer, as with some other cancers, is early detection. Patients who are diagnosed with Stage I colorectal cancer have a 74% 5-year survival rate compared with 6% for those diagnosed in Stage IV.⁷

Recently, studies have shown that when used annually for interval screening as part of a colonoscopy scheduled surveillance program InSure® FIT™ diagnosed colorectal cancer 25 months (median) earlier and advanced adenomas 24 months earlier, in a high risk population.⁸ Furthermore, in the same study, patients who had repeated negative results from InSure® FIT™ test has an almost 2-fold decrease in risk for colorectal cancer and advanced adenoma compared with patients who were not tested.

The American Cancer Society colorectal cancer screening guidelines state that fecal occult blood tests or fecal immunochemical tests are to be performed on an annual basis to retain their effectiveness as a screening method.⁵