PromarkerD’s ability to diagnose and predict diabetic kidney disease in patients was verified by the Promarker™ platform and studied in three clinical studies:
The Diagnostic Study
In this study, the protein biomarkers for diabetic kidney disease were statistically scrutinised against the current gold standard diagnostic for diabetic kidney disease tests, albumin-creatinine ratio (ACR) and the estimated glomerular filtration rate (eGFR), on an analysis of 572 patients. A protein biomarker discovery workflow was applied to blood samples from patients at different stages of diabetic kidney disease.
The study showed that PromarkerD outperformed both the current gold standard tests used for the diagnosis of patients already suffering from DKD. The results of this study were published in a specialist proteomics journal (EuPA Open Proteomics) to describe the technology platform and its basic application to diabetic kidney disease as a new diagnostic test.
The Prognostic Development Study
In this study, the prognostic ability of the novel diagnostic protein biomarkers for diabetic kidney disease was assessed for predicting rapid eGFR (a measure of kidney function) decline in patients with type 2 diabetes. A four year study was commenced with 576 patients enrolled in the study. Over the full duration of the study, complete clinical and experimental data was collected from 345 patients.
This clinical study showed that PromarkerD can correctly predict 95% of otherwise healthy diabetics who go on to develop chronic kidney disease within four years. The results of the Predictive Development Study were published in Diabetes Care, the journal of the American Diabetes Association and one of the top two diabetes publications in the world.
The Prognostic Validation Study
In this study, the robustness of the models determined from the predictive development study was assessed in an independent group of 500 patients over a four year period. Over the full duration of the study complete clinical and experimental data was collected from 447 patients.
In this validation study, PromarkerD correctly predicted 86% of previously disease-free patients who went on to develop chronic kidney disease. Although this larger validation study showed slightly lower levels of predictive ability, it is important to note that this was accompanied by a 10% improvement in levels of false positives.
The results of the Predictive Validation Study were presented in a poster at the 77th Annual Scientific Sessions of the American Diabetes Association in San Diego in June 2017, and at the Australian Diabetes Society conference in Perth in September 2017. Subsequently, the results were published in the Journal of Diabetes and its Complications August 2019 edition.