Project: Developing the Next Generation of Fecal Diagnostics

Short Description: _x000D__x000D_A patented Gentian high-speed prototype homogeneous turbidimetric calprotectin immunoassay has been developed for serum and plasma, and with calibration based on dry weight measurements of purified calprotectin and mass spectroscopy analysis. The assay is ready for adaption to measure fecal calprotectin in fecal sample extracts. _x000D_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. _x000D_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 relatively slow and expensive compared with high-speed turbidimetric immunoassay technologies. _x000D__x000D__x000D__x000D_The Underlying Idea: _x000D__x000D_The CO 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. _x000D_Gentian has created a strategic alliance with Mindray (China) to develop the coming market for low-price, high-quality clinical chemistry instruments. _x000D_University Ps 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 will be tested and verified. _x000D__x000D_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 results. A new easy-to-handle stool sampling device will be tested and verified._x000D__x000D_BÜHLMANN will validate, register, market and distribute the results of this project to the global market._x000D__x000D_State of the Art: _x000D__x000D_A homogeneous immunoturbidimetric assay for calprotectin in biological samples has not previously been available. Separation-based microtiter plate-based assays and lateral flow chromatography methods are not suitable for rapid automatic testing on large or small scale routine clinical chemistry photometric platforms. _x000D__x000D_CO Project Goals: _x000D__x000D_1. Verify a novel homogeneous turbidimetric calprotectin immunoassay for fecal diagnostics with the following characteristics: _x000D_1.1. Assay runs on clinical chemistry platforms found in all hospitals and commercial laboratories _x000D_1.2. Assay is of robust design, high sensitivity, and exhibits a large dynamic range_x000D_1.3. Assay is of high quality and price-competitive with existing fecal calprotectin assays _x000D_1.4. Assay has high clinical accuracy and low inter-laboratory and cross-platform CV._x000D_2. Research and verification of the use of turbidimetric fecal calprotectin with Karolinska and Uppsala University Hospitals on large and small-scale clinical chemistry platforms. _x000D_3. Perform customer-based field-testing of assay reagents in cooperation with clinical Ps._x000D_4. Measure reference intervals for fecal calprotectin in representative patient cohorts._x000D_5. Develop a fecal extraction robot to meet current and future customer requirements. _x000D_6. Develop a fecal sampling methodology for patients, and standard procedures for sampling, transport and handling of fecal samples._x000D__x000D__x000D_Secondary Project Goals: _x000D__x000D_1. Use the acquired data to secure extended IP rights _x000D_2. Publish findings in the scientific literature _x000D_3. Initiate full-scale calprotectin research projects with leading international research groups _x000D_4. Establish avian antibodies as a leading technology for the development of homogeneous turbidimetric immunoassays _x000D__x000D__x000D_Consortium Ps:_x000D__x000D_Gentian Technology AS is an SME and the technology driver with wide experience in nanoparticle technology and immunoassay research. Gentian is the project owner. _x000D__x000D_BÜHLMANN Laboratories AG is an SME and the worldwide leading producer of fecal-cal assays with a global market presence. _x000D__x000D_Getica AB is a specialized biotech SME concentrating on bioorganic coupling chemistries and bioprocessing of protein conjugates and nanoparticles. _x000D__x000D_Uppsala University Hospital (UUH) is a world leading institution for clinical medicine and clinical chemistry research. Uppsala University Hospital is the largest user of calprotectin ELISA in Sweden and has a large patient base for clinical studies. _x000D__x000D_Karolinska University Hospital (KUH), is a world leading institution for clinical medicine and clinical chemistry research. Dr Aleksandra Mandic Havelka is a research chemist with special interest in fecal calprotectin and the S100 protein family. Dr Havelka is responsible for the external quality assurance program for calprotectin within the Swedish EQUALIS laboratory quality control organization. _x000D__x000D_

Acronym Fecal-Calprotectin (Reference Number: 7991)
Duration 01/03/2013 - 29/02/2016
Project Topic Fecal Calprotectin differentiates IBS and IBD. 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.
Network Eurostars
Call Eurostars Cut-Off 9

Project partner

Number Name Role Country
5 Karolinska University Laboratory, Clinical Chemistry Partner Sweden
5 Getica AB Partner Sweden
5 Gentian Technology AS Coordinator Norway
5 Uppsala University Academic Hospital Partner Sweden
5 BÜHLMANN Laboratories AG Partner Switzerland