The InSure® FIT™ fecal immunochemical test is based on the immunochemical detection of human hemoglobin (Hb) as an indicator of blood in the stool. The assay uses a monoclonal antibody directed against the globin portion of Hemoglobin to identify the presence of Hb on a test strip. Since globin does not survive passage through the upper gastro intestinal (g.i.) tract, the presence of globin in the stool indicates bleeding in the colon and rectum.

In one study, the InSure FIT test with the more convenient Blue Brush Method had as much as 66% better compliance compared to a leading guaiac-based FOBT screening test.¹ Increased compliance with the InSure FIT means more patients are screened for colorectal cancer.

A randomized, controlled trial evaluated the clinical performance of the InSure FIT test and Hemoccult® II SENSA® in 2512 subjects in a diagnostic cohort of symptomatic subjects and a screening cohort of asymptomatic subjects. Subjects with positive test results underwent colonoscopy.  The study found that the InSure FIT test had an 87% sensitivity for colorectal cancer and 33% greater sensitivity for colorectal cancer than Hemoccult II SENSA.  The study was funded in part by Enterix (Enterix Australia Pty. Ltd.), the manufacturer of the InSure FIT test.  Enterix is now owned by Quest Diagnostics.  However, neither Enterix nor Quest Diagnostics participated in the data analysis or influenced the conclusions reached by the authors.²

1. Cole SR, Young GP, Esterman A, Cadd A, Morcom J. A randomized trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. J Med Screen 2003;10:117-122.
2. Smith A, Young GP, Cole SR, et al. Comparison of a brush-sampling fecal immunochemical test for hemoglobin with a sensitive guaiac-based fecal occult blood test in detection of colorectal neoplasia. Cancer. 2006;107:2152-2159.  The study was funded in part by Enterix Inc. (through Enterix Australia Pty. Ltd), the manufacturer of InSure FIT.  Enterix is now owned by Quest Diagnostics Incorporated.  However, neither Enterix nor Quest Diagnostics participated in the data analysis or influence the conclusions reached by the authors.  One of the authors, GP Young, is a consultant for Enterix Australia Pty. Ltd.