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National Services Division Commissioning for Scotland's Health

Molecular Pathology testing in Scotland


In October 2011 the Scottish Government Health and Social Care Diagnostic Steering Group approved a phased approach to the development of a national Consortium for Molecular Pathology and the process for designating and performance managing molecular pathology laboratories as a national service.

Molecular Pathology services have been nationally commissioned as a single designated multi-site national specialist service for NHS Scotland – from 1 April 2013. Tests are provided on 4 sites within regional centres – Aberdeen, Dundee, Edinburgh and Glasgow - and work is in hand to map out the list of tests, reduce unnecessary duplication and ensure equity of access. The current test list is attached:

Molecular Pathology testing in Scotland [XLS file, 204Kb]

Molecular Pathology Consortium Steering Group

The Molecular Pathology Consortium (MPC) Steering Group has been established to provide a forum for collaborative discussion and decision making on molecular pathology testing in Scotland.

The remit and expected outputs of the group are to:

  • provide a forum for collaborative discussion and decision-making on which tests will be provided in Scotland, in which laboratories and the priorities for introducing new tests.
  • ensure that everyone in Scotland has access to the same high quality and timeliness of molecular pathology tests, regardless of geographical location.
  • review annual activity, past trends and project forward likely future trends in activity and the quality of molecular pathology laboratory testing in Scotland;
  • share information, audit performance, and share good practice;
  • pursue opportunities for improving quality effectiveness and efficiency to make use of available resources.
  • horizon scan and plan for sustainable services for the future

Decision making on the tests provided nationally will be on the recommendations of the Molecular Pathology Evaluation Panel.

Molecular Pathology Evaluation Panel

The Molecular Pathology Evaluation Panel (MPEP) had its inaugural meeting in September 2013 where the group role, remit, membership, and reporting structure were agreed. The MPEP will use the ‘Framework for Decision Making for tests in the Scottish Molecular Pathology Service’ to appraise the evidence on test submission form to evaluate molecular pathology tests that are being provided. Tests will be assessed against set criteria and the Panel will make recommendations to Molecular Pathology Consortium on the clinical validity, analytical validity and clinical utility of tests that should be provided on a national basis. The framework was based on UK GTN Test Evaluation Process and Scottish Medicines Consortium submission process.

The Panel consists of a number of members from specific disciplines of specialities to assess test submission forms purely from a scientific review perspective. The Panel will be supported by a pharmacist and health economist from SMC to provide advice and critical appraisal as required. The membership also allows the opportunity to increase molecular pathology input into SMC assessments involving companion diagnostics.

It is the intention that the Panel will evaluate new companion diagnostics alongside the SMC assessment process. It is therefore proposed to add a sub-section to the pharmacoeconomics section of the New Product Assessment Form (NPAF) to cover companion diagnostics (where relevant) – designed to clarify test strategy, accuracy of test, cost of test and consumables/equipments etc and numbers of patients eligible for testing across Scotland. These issues are currently included in the pharmacoeconomic section of the NPAF, the introduction of a separate sub-section will allow these details to be shared with the Panel.

The introduction of tests will be a two-stage process: the Panel would evaluate and appraise proposed new tests and the Molecular Pathology Consortium would consider resource implications of test and decide in which laboratory(s) the test will be undertaken based on the recommendations of the Panel. The Panel’s Criteria for Decision Making is attached:

MPEP Criteria for Decision Making 1.0 [64Kb, 2 pages]

The decision making framework will be retrospectively applied to all tests that are currently being undertaken.