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New blood test shows strong ability to predict diabetic kidney disease risk in Aboriginal Australians - results published in peer-reviewed journal
FAST FACTS:
- High-risk population: The burden of diabetic kidney disease (DKD) is around seven times higher in Aboriginal Australians than in non-Indigenous Australians1.
- Peer-reviewed evidence: PromarkerD’s performance in Aboriginal Australians was validated in a peer-reviewed study published in the Internal Medicine Journal.
- Comparable accuracy: The test showed no statistically significant difference in predictive accuracy between Aboriginal and non-Aboriginal participants.
- Strong rule-out power: PromarkerD demonstrated a negative predictive value greater than 85%, reliably identifying people unlikely to experience near-term kidney decline.
- Early prediction: PromarkerD can predict diabetic kidney disease up to four years before clinical symptoms appear, enabling earlier and more targeted intervention.
Proteomics International Laboratories Ltd (ASX: PIQ) announced new peer‑reviewed clinical findings showing that its PromarkerD predictive blood test demonstrates clinically meaningful accuracy for identifying future diabetic kidney disease (DKD) risk in Aboriginal Australians, one of the highest‑risk populations for kidney failure globally.
The study, published in the Internal Medicine Journal, showed no statistically significant difference in test performance between Aboriginal and non‑Aboriginal participants, supporting PromarkerD’s broader clinical applicability.
The analysis included 1,081 adults with diabetes, including 71 Aboriginal participants, drawn from the Fremantle Diabetes Study Phase II and the Aboriginal Diabetes Sub‑study. PromarkerD was assessed for its ability to predict incident DKD or rapid kidney function decline over four years.
In Aboriginal participants, PromarkerD achieved an acceptable predictive accuracy with an area under the ROC curve (AUC) of 0.71, comparable to the non‑Aboriginal cohort (AUC 0.89). Importantly, the test delivered a high negative predictive value exceeding 85%, demonstrating strong ability to rule out medium‑term kidney decline and support more efficient allocation of healthcare resources2.
Proteomics International Managing Director Dr Richard Lipscombe said the findings highlight the importance of validating prognostic tools in high‑risk communities.
“Aboriginal people bear a disproportionately high burden of diabetes and diabetic kidney disease, often with earlier onset and faster progression. A reliable prognostic test such as PromarkerD has the potential to support earlier intervention and improve long‑term outcomes,” Dr Lipscombe said.
Professor Tim Davis, consultant physician and endocrinologist at Fremantle Hospital and a Professor of Medicine at The University of Western Australia said, “these findings show that PromarkerD has potential to support earlier, more accurate identification of kidney disease risk in Aboriginal people with type 2 diabetes. Early prediction is critical in this population, and a reliable test such as PromarkerD can help clinicians focus preventive care where it is needed most - it offers a significant opportunity to improve chronic disease management in remote and regional Aboriginal communities.”
Diabetes‑related chronic kidney disease is a serious complication that can progress silently and ultimately lead to dialysis or kidney transplantation if not detected early. In Australia, the overall burden of DKD is approximately seven times higher for Aboriginal people compared to non‑Indigenous Australians.
PromarkerD is a validated blood test that can predict diabetic kidney disease up to four years before clinical symptoms appear, supporting clinicians to make earlier, informed treatment decisions to improve outcomes for patients with type 2 diabetes.
Glossary
Sensitivity (Sn) (true positive rate) | The ability of a test to correctly identify those with the disease. E.g. sensitivity of 80% means that for every 100 people with disease, the test correctly diagnosed 80 with the condition. |
Specificity (Sp) (true negative rate) | The ability of the test to correctly identify those without the disease. E.g. specificity of 75% means that for every 100 people without disease, a test correctly identifies 75 as not having the condition. |
Negative Predictive Value (NPV) | The probability that people who get a negative test result truly do not have the disease. Also known as 'rule-out' rate, it is the probability that a negative test result is accurate. |
Positive Predictive Value (PPV) | The probability that a patient with a positive (abnormal) test result actually has the disease. |
Probability (P) | The P value, or calculated probability, that an observation is true. Most authors refer to statistically significant as P < 0.05 and statistically highly significant as P < 0.001 (less than one in a thousand chance of being wrong). |
AUC | "Area Under the ROC Curve". A receiver operating characteristic curve, or ROC curve, is a graphical plot that illustrates the performance of a classifier system. |
Interpreting AUC values | Conventionally the clinical significance of AUC is: > 0.7 acceptable discrimination > 0.8 excellent discrimination > 0.9 outstanding discrimination |
For comparison, the statistical performance of the Prostate-Specific Antigen (PSA) diagnostic test (blood test measuring the concentration of the PSA protein) for the diagnosis of prostate cancer is3:
- Prostate cancer versus no cancer: AUC 0.68
- PSA cut-off threshold 3ng/ml: Sensitivity 32%, Specificity 87%
Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ), is a pioneer in precision diagnostics, based in Perth.
LINK to publication: Internal Medicine Journal: https://doi.org/10.1111/imj.70275
Disclaimer: This blood test has not been approved by the TGA.
References
[1] https://doi.org/10.3389/fmed.2025.1561566
[2] https://doi.org/10.1111/imj.70275
[3] pubmed.ncbi.nlm.nih.gov/15998892/; JAMA. 2005 Jul 6;294(1):66-70; doi: 10.1001/jama.294.1.66
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