ProMarkerD: Diabetic Kidney Disease Risk

Test Introduction

The PromarkerD test identifies adult patients with type 1 and 2 diabetes which are at increased risk of experiencing kidney function decline in the next 4 years. PromarkerD predicts the risk of otherwise healthy patients developing incident diabetic kidney disease (eGFR <60 ml/min/1.73m2). If the patient’s eGFR level at the time of the test is already <60 ml/min/1.73m2, then the risk of further kidney decline (defined as eGFR decline ≥30%) is provided.

Test Description

PromarkerD is based on the measurement of three novel plasma protein biomarkers (ApoA4, CD5L and IGFBP3) using a standard immunoassay (ELISA) platform. The biomarker concentrations are combined with 3 clinical factors (age, HDL-cholesterol and eGFR) measured at the time of the test. The combined raw data is submitted to the PromarkerD Hub, and a test report with the patient risk score (0-100) and risk category (low-, moderate-, or high-risk) is generated. This risk prediction is concerned with the trajectory of the patientsʼ eGFR over 4 years. A rapidly declining eGFR is one of the strongest indicators of significant renal problems and the progression of diabetic kidney disease.

Blood sample

A sample is drawn at clinic or pathology laboratory and sent to PacificDx for analysis

Biomarker analysis

Laboratory uses standard technology platform (immunoassay) to measure plasma protein biomarkers.

Analysis software

Cloud-based algorithm calculates patient kidney disease risk score

Patient is classified as LOW RISK, MODERATE RISK, or HIGH RISK

Intervention plan

Clinician delivers results to patient

A personalised intervention/ management plan is created

Test Ordering

ProMarkerD is available for purchase directly through the ProMarkerD website. The test is performed in the Proteomics International Clinical Laboratory located in the ResearchDx Incubator Facility. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes

Sample Collection and Shipping Instructions

ProMarkerD is available for purchase directly through the ProMarkerD website. Acceptable sample types are Blood collected in K2-EDTA tubes. Collect a total of 20 mL of whole blood into the 2 K2-EDTA tubes, and ship at 15-25C within 24 hrs of collection.