Proteomics International PromarkerD LDT immunoassay (ELISA)

PromarkerD is a blood test designed to assess an individual’s risk of developing chronic kidney disease (CKD) up to four years before clinical symptoms appear. CKD will affect approximately one in two adults living with diabetes in their lifetime and remains the leading cause of end-stage kidney disease worldwide.

Current diagnostics, such as estimated glomerular filtration rate (eGFR) and albuminuria (ACR), typically identify kidney damage only after significant and irreversible damage has occurred. PromarkerD is designed to address this gap by enabling earlier risk stratification, supporting more proactive clinical decision-making.

PromarkerD measures two plasma protein biomarkers, apolipoprotein A4 (ApoA4) and CD5 antigen-like (CD5L), using a standard ELISA-based workflow. Biomarker concentrations are combined with clinical variables including patient age and eGFR value to generate an individualised CKD risk score.

The assay is performed at Proteomics International’s NATA and CLIA-CAP accredited clinical and precision diagnostics testing laboratories in Australia and the US, respectively. The assay is designed to support diabetes care and CKD risk assessment in primary care by GPs.

The test is said to predict risk of CKD up to four years before clinical symptoms appear; uses a standard ELISA platform; combines protein biomarkers with routine clinical variables; stratifies patients into low-, moderate- or high-risk categories; and supports earlier identification of patients who may benefit from closer monitoring or earlier intervention to avoid or delay the progression to CKD.

According to Proteomics International, clinical validation studies involving more than 5000 adults with type 2 diabetes have demonstrated strong predictive performance (Odds Ratio >44), including identification of patients at risk of kidney function decline who are not detected using standard-of-care tests.