E!7991 Developing the Next Generation of Fecal Diagnostics

A patented Gentian high-speed prototype homogeneous turbidimetric calprotectin immunoassay is undergoing clinical trials in Sweden and USA. Clinical chemistry analyzers from low-price producers have created an opening for dedicated cheap diagnostic platforms. Fecal extraction robots are on trial at two hospital sites in Sweden. Fecal calprotectin is an excellent differentiator for IBS (Irritable Bowel Syndrome) and IBD (Intestinal Bowel Disease). The differentiation between IBS and IBD is currently performed using ELISA fecal calprotectin methods. ELISA methods are slow and expensive compared with high-speed turbidimetric immunoassay technologies. The main goal of the project is to exploit a new Gentian European patent EP 1 739 430 and verify a novel turbidimetric calprotectin immunoassay for use with fecal extracts. A turbidimetric assay has the potential for significant cost saving for the medical community. Gentian has created a strategic alliance with Mindray (China) to develop the coming market for low-price, high-quality clinical chemistry instruments. A prototype high-speed turbidimetric calprotectin immunoassay is working and being tested on the modern routine clinical chemistry platforms found in hospitals and commercial laboratories. University partners are performing studies to support and document the new method. Bühlmann Laboratories who are the world's leading producer of fecal assays will validate, register and distribute the products developed in this project.

Objective: A high-speed turbidimetric calprotectin assay, improved fecal sampling and extraction device and fecal extraction robotics will improve patient diagnosis and generate significant cost-savings for the medical community. Short Description: A pa tented Gentian high-speed prototype homogeneous turbidimetric calprotectin immunoassay has been developed for serum and plasma. The assay is ready for adaption to measure fecal calprotectin in fecal sample extracts. Fecal extraction robots are on trial at two hospital sites in Sweden. Fecal calprotectin is an excellent differentiator for IBS (Irritable Bowel Syndrome) and IBD (Intestinal Bowel Disease). Differentiation between IBS and IBD is currently made using slower ELISA fecal calprotectin methods. The Underlying Idea: The main goal of the project is to exploit a new Gentian European patent EP 1 739 430 and verify a novel turbidimetric calprotectin immunoassay for use with fecal extracts. A turbidimetric assay has the potential for significant cost saving for the medical community. A high-speed turbidimetric method will work on all the modern routine clinical chemistry platforms found in hospitals and commercial laboratories. Gentian has created a strategic alliance with Mindray (China) to develo p the coming market for low-price, high-quality clinical chemistry instruments. University partners will perform studies to support and document the new method. A robotic system for faster and more hygienic handling of fecal matter and fecal extracts wil l be tested and verified. BÜHLMANN is the market leader in fecal calprotectin diagnostics and has extensive experience in fecal calprotectin extraction technologies, clinical use of such technologies, and clinical interpretation of the measurement resul ts. A new easy-to-handle stool-sampling device will be tested and verified. BÜHLMANN will validate, register, market and distribute the results of this project to the global market.