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MRC Molecular Pathology Review

In 2013, the MRC led a review (PDF, 1.22MB) of Molecular Pathology focussing specifically on defining the need for diagnostics and how they might be addressed, to better enable the potential benefits offered by stratification and molecular pathology to be captured.

The review found there are challenges to the delivery of improved diagnostics from molecular approaches across three domains:

  1. Lack of a defined development path: compared to therapeutics, the diagnostics development path is complex and poorly linked.
  2. Fragmented landscape: there is separation between the academic, pathology and industry sectors of the diagnostic development landscape.
  3. Complexity of multi-platform signatures: a growing proportion of diagnostic tests will be based upon the assessment of numerous markers drawn from many molecular classes (eg genetic, proteomic and metabolomic), the interpretation of which will require mathematical algorithms able to identify signatures characteristic of different disease strata.

To address these findings, the review sets out a vision that:

The UK will provide an optimal environment for the discovery, development and adoption of innovative molecular pathology tests, enhancing the benefits of stratified medicine for patients to deliver clinical, economic and research benefits.

In order to deliver this, the review steering group recommended that:

  •  Path: a clear map of the diagnostic development path should be produced, including the evidence needs of the regulatory, evaluation and commissioning organisations along the path. Consideration should also be given to whether these organisations provide appropriate coverage and support.
  • Proximity: the research base, pathology services and industry have become separated, to the detriment of all. These parties should be brought back into closer proximity.
  • People: the skills base of the UK should be enhanced, by developing future research.