EU Team Aims to Develop New Tests for Chronic Kidney Disease

A new European Union-funded project aims to develop new diagnostic approaches for early identification of patients at high risk of rapid loss of kidney function. "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," said Harry Holth, MD, PhD, of the University of Helsinki, Finland. Biomarkers identified, in particular those preceding the development of diabetic kidney damage during the pre-microalbuminuric stage, will be evaluated in patient sample material banks collected through a national effort relying on voluntary contributions of patients and health care professionals alike. This material is used by the researchers to find additional markers from diabetic urines, and identify new metabolic end products useful in diagnostics.

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 use antibody capture methods and newly developed antibody libraries. This will translate into early identification of patients at high risk of rapid loss of kidney function. The validation of the diagnostic tests will emerge from the use of the largest European urine, serum and DNA databases of diabetic nephropathy with the meticulously collected follow-up samples.

Subsequent steps of the test development include premarketing evaluation, transfer of the test into patient use, 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 and 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, said Holth.