Summary

Summary

  • The technology described in this briefing is PromarkerD. It is used for predicting the risk of diabetic kidney disease in people with type 2 diabetes.

  • The innovative aspects are that PromarkerD is designed to allow earlier or more accurate prediction of kidney disease in people with type 2 diabetes, which could lead to more appropriate treatment.

  • The intended place in therapy would be in addition to the standard care tests to predict renal function based on clinical symptoms of kidney disease in people with type 2 diabetes.

  • The main points from the evidence summarised in this briefing are from 4 studies (2 validation studies, 1 prospective study and 1 early discovery study) including a total of 5,789 people with type 2 diabetes. They show that PromarkerD is effective at predicting renal function decline in people with type 2 diabetes.

  • Key uncertainties around the evidence or technology are that the evidence base for PromarkerD is limited. No studies were done in the UK or NHS. Further studies including populations that represent those in NHS practice and that assess how the PromarkerD test leads to subsequent changes in clinical management and patient outcomes would be useful.

  • Experts advised that the technology is novel and is expected to be used in addition to standard care tests. They said that PromarkerD would cost significantly more than standard care, and long-term cost savings would be materialised only if adopting the test reduces the number of people who need end-stage renal failure treatments.

  • The cost of PromarkerD is £185 per unit (excluding VAT) and would be in addition to standard care. This cost includes the test and prognostic report for 1 person.