Media release

From: Proteomics International Laboratories Ltd (ASX:PIQ)

A blood test has been shown to outperform standard of care tests in predicting kidney decline in type 2 diabetes - results published in peer-reviewed journal

Fast Facts About Diabetic Kidney Disease (DKD)

• A Serious Complication: DKD is a major complication of diabetes, affecting kidney function and increasing health risks
• Global Impact: 10.5% of adults worldwide (537 million) have diabetes, including 32 million in the US and 1.5 million in Australia
• High Prevalence: Chronic kidney disease (CKD) affects up to 50% of people with type 2 diabetes
• Severe Consequences: If left unchecked, DKD can lead to dialysis or kidney transplant
• Need for Better Detection: Current standard tests have limitations in accurately predicting disease progression.

Australian medical technology Company, Proteomics International has announced the publication of its landmark study demonstrating a new blood test significantly outperforms conventional tests in identifying the risk of diabetes related chronic kidney disease (DKD). The blood test, called PromarkerD, has been previously validated for predicting renal decline up to four years in advance in type 2 diabetes.

The results were published overnight in the peer-reviewed journal Diagnostics as part of the Special Issue 'Current Issues on Kidney Diseases Diagnosis and Management 2025' in a paper titled "PromarkerD Versus Standard of Care Biochemical Measures for Assessing Future Renal Function Decline in Type 2 Diabetes" [1].

Proteomics International Managing Director Dr Richard Lipscombe said, “this peer-reviewed comparison against standard of care is critical in proving the power of PromarkerD to the medical community. As we acknowledge Kidney Health month in the US, we want to provide healthcare professionals with the best tools available to combat this debilitating disease.”

According to the American Society of Nephrology many patients suffer silently at first because chronic kidney disease is largely asymptomatic at the beginning. This lack of early detection can be fatal as kidney dysfunction that lasts longer than three months most often is irreparable [2].

Diabetes affects over 537 million people worldwide, and chronic kidney disease is a major complication, leading to severe health outcomes and increased mortality. Diabetes has emerged as the largest single cause of end-stage renal disease (leading to dialysis or kidney transplant) in developed and developing countries [3].

Summary of Study

Chronic kidney disease (CKD) affects up to 50 percent of people with type 2 diabetes, leading to severe health complications and increased healthcare costs. The current standard of care for the definition, classification, and prognosis of chronic kidney disease, defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines - the estimated glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio (uACR) - have severe limitations in accurately predicting disease progression.

The community-based study followed 857 adults with type 2 diabetes over four years and found that PromarkerD delivered significantly improved predictive accuracy, with an area under the receiver operating characteristic curve (AUC) of 0.88 compared to conventional tests, which ranged between 0.63 and 0.82 (p<0.001).

Participants classified as high risk of kidney decline by PromarkerD had significantly higher odds of experiencing the primary study endpoint [4] compared to those at low risk (Odds ratio (OR) 21.34), whereas KDIGO risk categories showed only modest degrees of association with the OR for high risk versus low risk at 1.28 (p<0.001).

Critical for patient management, PromarkerD identified 84 percent of individuals with normal kidney function at baseline who later developed significant kidney decline, cases that would have been missed by standard classification methods.

PromarkerD also exhibited an excellent “rule-out” rate, for categorising patients at low risk of developing DKD, and demonstrated considerably less false positives compared to standard of care testing.

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Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ), is a pioneer in precision diagnostics, based in Perth.

Disclaimer: This blood test has not been approved by the TGA.

References

[1] https://doi.org/10.3390/diagnostics15060662

[2] www.asn-online.org/nationalkidneymonth/

[3] pubmed.ncbi.nlm.nih.gov/31767176/

[4] Primary endpoint was defined as: eGFR < 60 mL/min/1.73 m2 ) or eGFR decline ≥ 30% over four years

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About Proteomics International Laboratories (PILL) (www.proteomicsinternational.com)

Proteomics International (Perth, Western Australia) is a wholly owned subsidiary and trading name of PILL (ASX: PIQ), a medical technology company at the forefront of precision diagnostics and bio-analytical services. The Company specialises in the area of proteomics – the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.