This proposal combines the accumulated expertise from a previous FP5 EU project, Mechanisms of Proteinuria (QLG1-2000-00691) and an ongoing FP6 project, ADDNET (LSHB-CT-2003-503 364). We will utilize the latest knowledge on the pathophysiology of diabetic nephropathy and newly identified urinary markers of diabetic kidney damage to develop a predictive diagnostic test to follow disease progression. Biomarkers identified, in particular those preceding the development of diabetic kidney damage during the pre-microalbuminuric stage, will be evaluated in prospective clinical studies. By metabolomics we aim to find additional markers from diabetic urine, and will identify antibodies recognizing these metabolites/peptides from an antibody phage display-library. In parallel, two separate approaches will be used to develop diagnostic tests, one based on nanobead technology and the other on a multiplexing platform allowing combination of several measurables into a single test. Both technologies will utilize antibody capture methods. This will translate into early identification of patients at high risk of rapid loss of kidney function. The validation of the diagnostic tests emerges from the use of the largest European urine, serum and DNA databases of diabetic nephropathy with meticulously collected follow-up samples. Subsequent steps of the test development include premarketing evaluation and transfer of the test into patient use by an SME of diagnostic service provider in Finland. Another SME will provide market and competitor analyses and search for best market channels for the test in international markets. This approach directly aiming at developing a clinical urinary test will be supported by extensive basic research on the mechanisms/biomarkers of diabetic nephropathy at the level of the kidney. These include a novel method of in vivo biotinylation and state of the art proteomics on kidney samples during the development of experimental diabetic nephropathy.
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Funding SchemeSTREP - Specific Targeted Research Project
5621 JG Eindhoven