1. Human Lactoferrin Lactoferrin is a glycoprotein secreted by mucosal membranes; it is a major protein in the secondary granules of leukocytesLactoferrin is a glycoprotein secreted by mucosal membranes; it is a major protein in the secondary granules of leukocytes During intestinal inflammation, activated leukocytes infiltrate the mucosa and lumen, increasing the level of fecal lactoferrinDuring intestinal inflammation, activated leukocytes infiltrate the mucosa and lumen, increasing the level of fecal lactoferrin Fecal lactoferrin is elevated in patients suffering from active inflammatory bowel disease (IBD) but not in persons with irritable bowel syndrome (IBD) or healthy personsFecal lactoferrin is elevated in patients suffering from active inflammatory bowel disease (IBD) but not in persons with irritable bowel syndrome (IBD) or healthy persons

2. Lactoferrin levels in disease 12008004000 Lactoferrin levels (ug/g wet weight) CrohnsDiseaseN=78 UlcerativeColitisN=71 IrritableBowelSyndromeN=31 HealthyPersonsN=56

3. Two new non-invasive tests to detect intestinal inflammation IBD-CHEK TM – a qualitative ELISA for the clinical labIBD-CHEK TM – a qualitative ELISA for the clinical lab IBD-QUIK CHEK TM – a qualitative lateral flow test for the clinical lab or physicians officeIBD-QUIK CHEK TM – a qualitative lateral flow test for the clinical lab or physicians office

4. Performance Characteristics of the IBD-CHEK Test N=236Total IBD-CHEK TM IBD-CHEK TM Crohns disease Active 52 85% 15% Inactive 2662% 39% Ulcerative colitis Active 40 88% 13% Inactive 3152% 48% Active IBS 31 0% 100% Healthy persons 56 0% 100% (+)(-)

5. Clinical Results with the IBD-CHEK When distinguishing active IBD from irritable bowel syndrome and healthy persons, the IBD-CHEK TM test exhibited a sensitivity of 86% and specificity of 100%When distinguishing active IBD from irritable bowel syndrome and healthy persons, the IBD-CHEK TM test exhibited a sensitivity of 86% and specificity of 100% When distinguishing active Crohns disease from irritable bowel syndrome and healthy persons, the IBD-CHEK TM test exhibited a sensitivity of 85% and specificity of 100%When distinguishing active Crohns disease from irritable bowel syndrome and healthy persons, the IBD-CHEK TM test exhibited a sensitivity of 85% and specificity of 100%

7. IBD-CHEK Test Qualitative ELISA for detecting elevated fecal lactoferrin as an indicator of intestinal inflammationQualitative ELISA for detecting elevated fecal lactoferrin as an indicator of intestinal inflammation Utilizes a four-step procedure with results in 75 minutesUtilizes a four-step procedure with results in 75 minutes A valuable noninvasive diagnostic aid to distinguish active IBD from IBSA valuable noninvasive diagnostic aid to distinguish active IBD from IBS Available by direct order for hospital and reference labsAvailable by direct order for hospital and reference labs