Diabetes is becoming the greatest health challenge of the 21st century. Globally there are 387 million people with diabetes, and the economic cost to Australia alone is over $14 billion annually.
Chronic kidney disease is a significant complication of diabetes that affects 35% of patients, leading to dialysis or kidney transplant, and in 15% of diabetics, death from kidney failure. Clinicians require better tools to deliver more effective diagnosis and monitor treatment to improve health outcomes. To achieve this a platform to discover, verify and validate biomarkers for such diseases is a crucial enabling technology.
Fundamental biomarker discovery was undertaken using proteomics, analysing highly curated clinical samples. The quantitative proteome wide results provided a putative list of candidate biomarkers. Verification of the biomarkers was achieved with a targeted mass spectrometry approach (MRM). The robustness of the targeted mass spectrometry assay was demonstrated by single digit intra-day and inter-day CV's.
A large longitudinal clinical study was then conducted following 500+ individuals with diabetes over a four year period. Both targeted mass spectrometry and traditional antibody based measurement systems were employed, with these independent platforms showing excellent correlation of results.
The study proved that a particular combination of protein biomarkers can be used both to diagnose, and to predict, the onset of disease. The resulting biomarker panel could provide a new tool for clinicians to diagnose diabetic kidney disease via a specialist laboratory developed test (LDT) or an in vitro diagnostic (IVD) for pathology laboratories, or as a companion diagnostic test (CDx) to monitor new drug therapies.