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Discovery and Validation of 13 Diabetes Biomarkers to be Commercialized

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After three years of collaborative research involving patients from The Busselton Health Study, drug discovery company Proteomics International announced the identification and analytical validation of 13 protein biomarkers for a significant complication of diabetes – diabetic nephropathy (kidney disease). In a presentation at the Human Proteome Organisation’s World Congress in Sydney, Australia, Dr Richard Lipscombe, Managing Director of Proteomics International, revealed the findings that could benefit many of the 250 million people worldwide who have diabetes.

The number of diabetic sufferers has doubled in the last decade with the total expected to top 430 million by 2030 (International Diabetes Federation). 10-20% of people with diabetes will die of kidney disease (renal failure).

“Applying our uniquely accredited proteomics biomarker expertise to patient samples (plasma) from the Busselton Health Study and the Fremantle Diabetes Study allowed us to analyse three well characterized clinical cohorts of selected disease groups (adults who had Type II diabetes and diabetic nephropathy)” said Dr Lipscombe. “The protein biomarkers that we found could now allow for the prediction of those patients who would progress to the development of kidney disease and provide new targets for drug therapies that prevent the onset of this serious complication.”

Proteomics International is actively seeking partners to further qualify and commercialize its patented diabetes biomarker portfolio. The company collaborates with Dr Tim Davis, Professor of Medicine at the University of Western Australia, and is part of the Western Australian Centre for Food and Genomic Medicine examining many aspects of diabetes including the early onset of type 2, obesity, hypoglycemia, and complications arising from type 1. Prof Davis explained, “When looking for biomarkers the challenges are to obtain very detailed individual data from the participants to get rid of potentially confounding variables when looking at associations. The strength of the Busselton Health Study is we have a wealth of retrospective clinical and laboratory information on top of the comprehensive data we collected.”

The protein biomarker discovery and validation approach included the analysis of pooled plasma samples for differential protein expression, i.e. proteins that are found at different levels in the diabetic disease state relative to the normal diabetic state. Candidate biomarkers were identified from iTRAQ labelled samples by 2D-LC MALDI TOF/TOF mass spectrometry, an emerging technique in proteomics. This discovery phase identified 130-200 proteins per cohort and across all studies over 50 proteins showed significant differences in concentrations. Biomarker candidates were validated in a second approach using the advanced mass spectrometry technique Selected or Multiple Reaction Monitoring (SRM/MRM) to carry out concentration analysis on individual patient plasma samples. Statistical data analysis of the validation phase identified 13 putative protein biomarkers for diabetic nephropathy across the studies, including proteins involved in metabolism, inflammation and oxidative stress. The complexity of the diabetic kidney disease suggests that there would not necessarily be one biomarker but a set of biomarkers (signature) in varying degrees to characterise the diabetic nephropathy state. These biomarkers can be used as diagnostic tools or new drug targets.

Source: Proteomics International