Leeds In Vitro Diagnostics Co-operative

New framework to accelerate development of biomarker tools

3 October 2018

A framework that will help scientists research and develop new biomarkers as diagnostic tools has been published. This work was undertaken as part of an NIHR Applied Programme and the NIHR Diagnostic Evidence Co-operative (DEC) Leeds.

Protein biomarkers are becoming increasingly attractive as simple, accessible and safe methods of diagnosing diseases and informing treatment decisions. Their potential is not being fully realised, however, because research practice in this area is not well developed.

In a seven-year programme led by Professor Peter Selby, researchers have been investigating the challenges of developing biomarker tests and have proposed a strategy for their future evaluation.

The programme included overviews of the role of biomarkers in monitoring diseases and an assessment of the use of early health economic modelling in their evaluation. The team demonstrated that it is possible to proactively create sample databanks in order to evaluate markers rapidly as they are identified and were able to show the value of this for a series of markers in kidney diseases.

In a randomised controlled trial, entitled ‘ELUCIDATE’, the team tested the role of an innovative biomarker for monitoring patients with chronic liver disease. Results showed that the biomarker strategy altered the process of care and the diagnostic outcomes for patients, although the team has yet to report on the long term effect on survival.

Professor Selby explains: “The overview and modelling information, the proactive approach to evaluating biomarkers rapidly and the role of ELUCIDATE as an exemplar trial for evaluating monitoring biomarkers should help speed up the incorporation of reliable biomarkers into healthcare practice. We anticipate this will be of use in the design of rapid, appropriate and methodologically robust studies not only in renal and liver disease, but also in many other areas of healthcare.”

Read the full report here.