Clinical evidence
PromarkerD’s ability to predict diabetic kidney disease in patients was validated in multiple clinical studies
The global multi-centre prognostic validation study
Retrospective analysis of blood samples from the completed clinical trial showed that patients classified as high-risk for chronic kidney disease by PromarkerD 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 can correctly predict a clinically significant decline in kidney function up to four years in advance.
Prognostic validation study in adults with type 1 diabetes
Utilising samples from participants of the community-based longitudinal Fremantle Diabetes Study Phase II, PromarkerD has proven to be highly accurate in predicting chronic kidney disease and kidney function decline in adults with type 1 diabetes up to 4 years in advance.
This is the first application of the PromarkerD test for predicting kidney decline in type 1 diabetes and extend the clinical utility of PromarkerD beyond its original target population of adults with type 2 diabetes. The additional application for type 1 diabetes patients with their unique clinical needs offers a new target market for PromarkerD and addresses a critical health issue for over 537 million people worldwide who have diabetes, with type 1 diabetes representing 10% of all cases. The results of this were presented at the Australasian Diabetes Congress in August 2024 and have been accepted for publication in the journal of Clinical Diabetes and Endocrinology.
Global multi-centre prognostic validation study (CANVAS)
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), June 2020 and 2022. Subsequently, the results were published in the Journal of Clinical Medicine.
Diabetes treatment lowers PromarkerD risk score (CANVAS)
A follow up study examined PromarkerD as a potential diagnostic tool to demonstrate the benefits of SGLT2-inhibitor, canagliflozin, in over 2,000 participants of the CANVAS-completed phase 3 clinical trial over a three-year follow-up period.
PromarkerD demonstrates the benefits of canagliflozin such that those participants taking the medication experienced significant reduction in their risk scores for developing diabetic kidney disease compared to placebo. Effect was greatest in participants predicted by PromarkerD to be at high-risk of a decline in kidney function at the start of the study. This study shows the power of using PromarkerD as a Precision Diagnostic tool to assist in the treatment and prevention of diabetic kidney disease. Research has been published as a feature article in the peer-reviewed Journal of Clinical Medicine.
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.
Multi-site assay validation study
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.
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 with type 2 diabetes 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.
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 adults 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 adults with type 2 diabetes who go on to develop chronic kidney disease within four years (ADA Poster 2017 & JDC 2019)
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 adults with type 2 diabetes at different stages of diabetic kidney disease.
The study showed that PromarkerD outperformed both the current gold standard tests used for the diagnosis of adults 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.
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