E!12838 Automated multiple marker test for diagnosis and monitoring of bowel diseases

Gastrointestinal (GI) diseases are often hard to diagnose because they have similar clinical symptoms, such as unexplained diarrhea, weight loss, maldigestion and abdominal pain. For these symptoms, the diagnoses could be Irritated Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Pancreatic Exocrine Insufficiency (PEI), Pancreatic Cancer (PC), Colorectal Cancer (CRC) and Chronic Pancreatitis (CP). Endoscopic methods (incl. colonoscopy) can be used to investigate these disease states, the main drawbacks being that it is expensive, invasive and can carry risks of infection for those suffering from IBD. International clinical guidelines therefore advice stool tests for fecal markers as the first step in the diagnostic workup to direct further investigations and treatment. Our GOAL in this project was to develop, validate, IP-protect and put to market diagnostic test for two fecal markers that are central in the diagnosis and stratification of gastrointestinal diseases: 1) Fecal Pancreatic Elastase (fPELA) is a measure for Pancreatic Exocrine Insufficiency (PEI) associated with various underlying diseases or conditions such as CP, CF, Celiac Disease, and Diabetes Mellitus. 2) Fecal hemoglobin (fHb) is used for detection of bleeding of the digestive tract. The test is used to look for active occult blood loss in anemia, when there are gastrointestinal symptoms, and in screening for colon cancer. Both tests would be made compatible to the buffer matrix of BÜHLMANN's patented stool sampling and extraction device (Calex®Cap) that has been developed for our joint fecal-Calprotectin test - the third key marker in GI-diseases measuring inflammation of the gut. Thus, only a single patient stool sample is needed to measure one, two or all three markers. Though all three tests can be used separately, for example for monitoring purposes (disease progress and success of treatment), the combined results have added value in the diagnosis and stratification of GI diseases. The project has resulted in a validated fPELA immunoassay and has been most satisfactory. The assay has been launched on the market and is already selling above expectations.Due to technical challenges, the fHb immunoassay has not been completed within the projec time frame.

VIRKNINGER The projected revenue and profits are significant and have already result in substantial growth of the companies involved. For our customers (distributors) and end users (hosptial and commercial laboratories) the test results in more efficient work-flow, higher throughput and lower costs. For patients, it means faster time to result, and a non-invasive method that will give good results. EFFEKTER Our innovation brings improvement in terms of costs and efficiency for the (medical) community compared to existing products. It allows for rapid, non-invasive diagnosis/exclusion/stratification of a range of gastrointestinal diseases based on one single stool sample.

In this project, we will develop, validate and bring to market a diagnostic "multiple marker" test for fecal samples that can be run on turbidimetric analyzers. Crucially, only one patient stool sample is required to measure several key markers to support rapid and accurate diagnosis and monitoring of a wide range of gastrointestinal diseases that often show diffuse clinical symptoms, including but not limited to Crohn's disease, Chronic Pancreatitis, Diabetes Mellitus, and Pancreatic and Colorectal Cancer. Following the successful performance of the partners' joint fecal Calprotectin test and stool extraction device, we have identified two new markers that will enhance this test and further strengthen our position in a highly competitive fecal diagnostic market. Both markers are backed by substantial clinical evidence and are well-established in the ELISA or POC format. Adaptation to open, turbidimetric platforms will be attractive because of low price, high throughput, and ease-of-use.