Chronic kidney disease (CKD) affects one in three adults with diabetes, accounting for 40,000 deaths and $100 billion (USD) in healthcare spending annually. The current tests for CKD, urinary albumin:creatinine ratio (ACR) and estimated glomerular filtration rate (eGFR), have limited accuracy to predict CKD progression.
PromarkerD is a blood test that measures three plasma protein biomarkers (CD5L, ApoA4, and IBP3) combined with three clinical factors (age, HDL-cholesterol and eGFR) to predict risk of renal decline in patients with type 2 diabetes (T2D) over the ensuing 4 years. PromarkerD was developed using a proteomics workflow in patients with T2D drawn from the longitudinal observational Fremantle Diabetes Study Phase II (FDS2). Two versions of the test were developed, a targeted mass spectrometry based assay and an ELISA assay, both of which were used to measure the PromarkerD plasma biomarkers. Risk predictions were compared between the two platforms using Bland and Altman plot analysis.
The plasma biomarkers add significant incremental benefit to conventional clinical risk factors for predicting rapid decline in renal function in T2D. The biomarkers outperform both eGFR and ACR for predicting future renal decline and provide physicians with a more informed approach to managing diabetic kidney disease and patient care. PromarkerD may also be useful for risk stratification in future clinical trials.