The Medical Research Council has reported its concerns over aspects of the UK’s molecular pathology landscape, saying that these could, if not addressed, inhibit the discovery, development and adoption of innovative diagnostic tests that will ultimately offer clinical, economic and research benefits.
UK investment in stratified medicines has totalled around £200 million in the last four years. To benefit from this investment, the UK must be able to develop and adopt new diagnostic tests and strategies, says the MRC, in a new review.
The three areas of concern which it identifies are: - the lack of a defined developmental pathway - compared to therapeutics, this is complex and poorly linked; - a fragmented landscape which separates the academic, pathology and industry sectors of the diagnostic development landscape; and – a need for complex diagnostic tests and mathematical algorithms that characterise differences in disease strata.
To address these deficiencies, the review is calling for a clear map of the diagnostic development pathway, including evidence of the regulatory, evaluation and commissioning organisations involved along the pathway. It also notes that the research base, pathology services and industry have become separated, to the detriment of all, and it calls for them to be brought back into closer proximity.
Finally, it says, the skills base of the UK should be enhanced by developing future research leaders in pathology and increasing capacity in data analysis and health economics.
“We have identified key areas that need to be addressed to allow the UK to reach its potential to become a world leader in molecular diagnostics. Achieving this goal will required the coordinated action of organisations spanning the diagnostic development path,” said Robert Lechler of King’s College London, chair of the review steering group.
Prof Lechler also welcomed the joint funding call launched by the MRC and the Engineering and Physical Sciences Research Council (EPSRC), which are to partner in the establishment of a number of regional Molecular Pathology Nodes – centres of excellence which will bring clinical and research skills and expertise closer together.
The MRC is contributing up to £15 million and the EPSRC up to 2.5 million towards a joint £17.5 funding pot, to support around eight awards of up to three years’ duration, with the aim of aligning molecular pathway diagnostic research, development and service delivery across a common infrastructure, with industry engagement.
The priorities outlined in the MRC review were welcomed by Louise Leong, director of R&D policy at the Association of the British Pharmaceutical Industry who said the industry wants to see a health service equipped with the capabilities to appropriately value and use diagnostics, and a joined-up R&D landscape with strong partnerships between the NHS, industry and academia.
“We also need to see the linking-up across the currently-fragmented areas of clinical research and use, pathology and industry, so that patients can ultimately benefit from access to existing and new treatments,” Dr Leong added.