Clinical Studies

PromarkerD’s ability to predict and diagnose diabetic kidney disease in patients was verified by the Promarker™ platform and characterised in six clinical studies:

The Global Multi-Centre Prognostic Validation Study

A global, multi-centre study of 3,000 people confirmed the effectiveness of PromarkerD as a predictive test for diabetic kidney disease. The collaborative study with Janssen applied the PromarkerD test system to patient samples from the CANVAS completed phase 3 clinical trial of patients with type 2 diabetes.

Retrospective analysis of blood samples from the completed clinical trial showed that patients predicted by PromarkerD to be at high-risk of chronic kidney disease were 13.5 times more likely than the low-risk group to develop the disease. The study provides international validation of previous findings that PromarkerD is able to correctly predict a clinically significant decline in kidney function up to four years in advance.

The results were presented at the world’s leading diabetes conference, the 80th Scientific Sessions of the American Diabetes Association (ADA), in June 2020. Subsequently, the results were published in the Journal of Clinical Medicine.

The Cross-Platform Assay Validation Study

Reproducible protein measurement across technology platforms is an essential component of determining a specific disease state, such as diabetic kidney disease. This publication proved there was high correlation between the advanced mass spectrometry (IAMS) platform and the traditional immunoassay (ELISA – enzyme linked immunosorbant assay) platform, with >90% of the samples achieving PromarkerD risk scores within 5% of the other platform’s score.

Both technology platforms were successfully validated for assay reproducibility, robustness and stability for the PromarkerD test system.

Cross-platform results were presented at the world’s leading proteomics conference, the 18th Human Proteome Organisation World Congress (HUPO) in September 2019. The cross-platform study was subsequently expanded, and complete results were published in the journal Proteomes.

The Multi-Site Assay Validation Study

The PromarkerD assay has already demonstrated clinical validity. This study refined the original research grade mass spectrometry assay to enable higher throughput and
clinical application. Independent analysis of the same set of samples across multiple laboratories proved the robustness of the protocol between different test sites (Proteomics International, the University of Sydney, and Atturos Ltd (Ireland)). The joint publication is one of the first validations of a proteomics derived multi-biomarker diagnostic test in a clinical setting.

Initial results were presented at the world’s leading proteomics conference, the 18th Human Proteome Organisation World Congress (HUPO) in September 2019. Subsequently, the results were published in the journal Clinical Proteomics.

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.

The results 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.

The Prognostic Development 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 study showed that a panel of biomarkers improved prediction of rapid eGFR decline independent of recognised clinical risk factors. The results were published in Diabetes Care, the journal of the American Diabetes Association and one of the top two diabetes publications in the world.

In this development study, PromarkerD correctly predicted 95% of otherwise healthy diabetics who go on to develop chronic kidney disease within four years.  (ADA Poster 2017 & JDC 2019)

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.