Advice
The technology
The technology
PromarkerD (Proteomics) is a blood test used to assess the risk of diabetic kidney disease in people with type 2 diabetes. The test combines 3 biomarkers measured by immunoassay (ApoA4, CD5L and IGFBP3) with 3 routine clinical factors (age, high-density lipoprotein [HDL]-cholesterol and estimated glomerular filtration rate [eGFR]). Using an algorithm, the test generates a prognostic risk score for a person developing diabetic kidney disease up to 4 years in advance. For the test, a plasma sample measures the 3 biomarkers and the software then generates a risk report which laboratory staff download and send to the clinician. People are classified according to 1 of 3 risk groups (low risk, moderate risk and high risk) which informs the level of monitoring and management strategies required. People with a high-risk PromarkerD prognostic risk score would be retested every 3 months, moderate risk every 6 months and low risk every 12 months.
Innovations
There is currently no available test to predict renal function decline in people with type 2 diabetes. PromarkerD predicts the likelihood of occurrence of kidney disease in people without symptoms, which may allow earlier or more accurate diagnosis and could lead to more appropriate treatment.
Current care pathway
The current care pathway for diabetes care includes an annual health check for blood glucose, lipid profile and kidney function. The kidney function tests measure eGFR and urine albumin to creatinine ratio (uACR). These results provide a measurement of the current state of a person's kidneys to inform the most appropriate intervention. Based on the physician's assessment, clinical and laboratory risk factors may be monitored every 3, 6 or 12 months.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
PromarkerD tests are intended to be used to predict the onset of diabetic kidney disease in people with type 2 diabetes or further decline in kidney function in patients with existing diabetic kidney disease. Tests are likely to be requested by primary care clinicians in GP surgeries, as well as by endocrinologists and nephrologists in secondary care. Plasma samples are sent to the manufacturer's laboratory, where trained personnel test the samples and input data into cloud-based software to generate a report which is sent back to the clinician.
No additional training would be needed for clinicians, other than understanding how to interpret the report.
Costs
Resource consequences
The technology is not currently used in the NHS. The PromarkerD test is expected to be used in addition to the current standard care tests to estimate renal function. PromarkerD is intended to diagnose kidney disease earlier, which allows earlier intervention, potentially slowing down diabetic kidney disease progression. Blood samples may need to be sent to alternative laboratories for processing of results. No infrastructure changes are associated with adopting the technology.