by University of Western Australia

Areas under the curve (AUC) of the receiver operating characteristic for PromarkerD, eGFR, uACR, and eGFR + uACR in predicting the primary renal outcome (left-hand panel) and for PromarkerD in predicting primary and secondary outcomes (right-hand panel). Credit: Diagnostics (2025). DOI: 10.3390/diagnostics15060662

An Australian medical technology company, Proteomics International, has published a 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 in the journal Diagnostics in a paper titled "PromarkerD Versus Standard of Care Biochemical Measures for Assessing Future Renal Function Decline in Type 2 Diabetes."

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 U.S., we want to provide health care 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 is most often irreparable.

Diabetes affects more than 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.

Summary of study

Chronic kidney disease (CKD) affects up to 50% of people with type 2 diabetes, leading to severe health complications and increased health care 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 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% 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 categorizing patients at low risk of developing DKD, and demonstrated considerably fewer false positives compared to standard-of-care testing.

More information: Kirsten E. Peters et al, PromarkerD Versus Standard of Care Biochemical Measures for Assessing Future Renal Function Decline in Type 2 Diabetes, Diagnostics (2025). DOI: 10.3390/diagnostics15060662