Test Ordering

The Importance of Testing for Diabetic Kidney Disease

 

 

Limitations of Current Diagnostics

  • Urinary albumin to creatinine ratio (uACR)
  • Estimated glomerular filtration rate (eGFR)
  • Cannot predict the risk of developing diabetic kidney disease (DKD)
  • Detect DKD only after kidney damage has occurred
  • Subject to substantial intra-individual variability
  • Can give inconsistencies between ACR and eGFR results leading to an inconclusive diagnosis

Failure to detect DKD early can lead to irreversible kidney damage, reduced life expectancy, and a large toll on the healthcare system.
Early detection can delay or prevent the progression of DKD.

Our Solution

PromarkerD Test System

  • Predicts the risk of DKD in patients with type 2 diabetes
  • A simple blood test that measures 3 plasma biomarkers combined with 3 clinical factors
     

Point of Difference

  • PromarkerD is the only low-cost, high-speed test capable of predicting the onset of DKD
  • PromarkerD predicts the onset of DKD before clinical symptoms appear – in validated clinical studies the PromarkerD test system predicted 86% of otherwise healthy diabetics who went on to develop chronic kidney disease within four years

Prevention is better than cure

Early detection of DKD can transform clinical outcomes for the patient and the healthcare system.

Clinical Utility

PromarkerD enables a more comprehensive assessment and informed approach to help:

  • Identify patients with type 2 diabetes at-risk of developing DKD within the next four years
  • Implement preventative measures before kidney damage occurs
  • Personalize patient treatment plans
  • Improve patient monitoring and management

What can be done?

  • Early-stage chronic kidney disease can be treated through dietary changes, lifestyle modifications and medications, all of which ensure a relatively better quality of life
  • ADA new guidelines3 recommend use of SGLT2 inhibitors in type 2 diabetes patients as an additional agent for lowering glucose - and for lowering cardiovascular and renal risk in patients predisposed to these complications
  • FDA approved SGLT2 inhibitors to treat type 2 diabetes - canagliflozin, empagliflozin and dapagliflozin
    - Currently, ~20 DKD drugs are at different stages of clinical trials

How the Test Works

Analysis

  • A panel of three novel biomarkers is analyzed by ELISA
    ApoA4
    CD5L
    IGFBP3
  • Biomarker concentrations are combined with 3 clinical factors: Age, HDL-cholesterol, eGFR


Risk Score Generation

  • Combined raw data is analyzed by a proprietary algorithm within the PromarkerD Hub software tool
  • An enhanced report is generated and included with each result

Two Test Cut-off Points

  • The test result is presented as ‘low, moderate, or high risk, based on derived cut-off points that were selected to optimize test performance

    Moderate risk: provides optimal sensitivity to increase true positives

    High risk: provides optimal specificity to reduce false positives

View Low Risk Example Report

View Moderate Risk Example Report

View High Risk Example Report

Results and Interpretation4

LOW RISK Standard diabetes management is recommended; Status tested annually.

MODERATE RISK

More frequent monitoring; Optimization of lifestyle factors; Review of glycemic targets and management; Review of non-glycemic risk factors and their management including blood pressure and lipids; Avoidance of potentially nephrotoxic drugs; Only for High-risk patients; Status tested every 6 months.

HIGH RISK

Very close monitoring; Intensive management strategies based on those for ‘Moderate risk’ above with optimization of treatments for diabetes and other risk factors. Utilization of therapeutic drugs with evidence of renoprotection; Status tested every 3 months.

References:

1. https://www.kidneyfund.org/assets/pdf/infographics/diabetes-and-kidney-disease.pdf

2. https://www.cdc.gov/kidneydisease/prevention-risk/make-the-connection.html

3. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2021.

4. Based on the ADA Standards of Medical Care in Diabetes 2022. American Diabetes Association Professional Practice Committee. 11. Chronic kidney disease and risk management: Standards of Medical Care in Diabetes—2022. Diabetes Care 2022;45(Suppl. 1): S175–S184.

This test was developed and its performance characteristics were determined by Sonic Reference Laboratory (SRL). It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research. SRL is qualified to perform high complexity testing under the Clinical Laboratory Improvement Amendments (CLIA).