The Medical Research Council (MRC) has published a review of the U.K.’s capabilities in molecular pathology—the discipline that uses analysis of the molecules within tissue and body fluids to aid in a more accurate diagnosis and monitoring of disease. The review identifies three areas which, if not addressed, could inhibit the discovery, development and adoption of innovative diagnostic tests that will ultimately offer clinical, economic and research benefits.

The U.K. government and charity funders, including the Technology Strategy Board, the MRC, the National Institute for Health Research (NIHR), Cancer Research U.K. and Arthritis Research U.K., collectively have invested $331.5 million in stratified medicine in the last four years, coordinated via the Stratified Medicine Innovation Platform (SMIP). The aim of stratified medicine is to better understand the different sub-groups of patients that may exist within a single disease such as breast cancer, asthma or diabetes, and to develop more targeted treatment strategies.

In order to benefit from this substantial investment, it is critical that the U.K. is able to develop and adopt new diagnostic tests and strategies. The MRC has therefore undertaken a review of the challenges faced by diagnostic test developers in the current climate.

The three areas of concern identified in the review highlight:

• The lack of a defined developmental pathway, which compared to therapeutics, is complex and poorly linked
• A fragmented landscape that separates the academic, pathology and industry sectors of the diagnostic development landscape
• A need for complex diagnostic tests and mathematical algorithms that can characterize differences in disease strata.

To address these findings, the review steering group recommended that:

• A clear map of the diagnostic development pathway should be produced, including the evidence of the regulatory, evaluation and commissioning organizations involved along the pathway
• The research base, pathology services and industry have become separated, to the detriment of all, and should be brought back into closer proximity
• The skills base of the U.K. should be enhanced by developing future research leaders in pathology and increasing capacity in data analysis and health economics.

Professor Sir John Savill, chief executive of the MRC, said, “U.K. government and charitable funders, including the MRC, have committed more than $331.5 million to stratified medicine in the last four years. However, for the U.K. and patients to fully benefit from this investment, we must create the very best environments for the discovery, development and uptake of new therapies and diagnostic tests. The MRC has undertaken a review of the challenges facing those developing novel diagnostic tests, so we can better understand what is needed for the U.K. to fully capture the clinical, economic and research benefits that stratified medicine has to offer."

Chair of the review steering group, Professor Sir Robert Lechler, from King’s College London, said, “We have identified key areas that need to be addressed to allow the U.K. to reach its potential to become a world leader in molecular diagnostics. Achieving this goal will require the coordinated action of organizations spanning the diagnostic development path.”

In recognition of the need and value of bringing together clinical and research skills and expertise, the MRC and Engineering and Physical Sciences Research Council (EPSRC) have agreed to partner in the establishment of a number of regional Molecular Pathology Nodes—centers of excellence that will bring clinical and research skills and expertise closer together. The MRC is contributing up to $24.9 million and EPSRC up to $4.1 million toward a joint $29 million funding pot. It is anticipated this will support about eight awards of up to three years’ duration, with the aim of aligning molecular pathology diagnostic R&D and service delivery across a common infrastructure, with industry engagement.