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CM-Path Molecular Diagnostics Forum—consensus statement on the development and implementation of molecular diagnostic tests in the United Kingdom
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CM-Path Molecular Diagnostics Forum—consensus statement on the development and implementation of molecular diagnostic tests in the United Kingdom
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Journal Article
CM-Path Molecular Diagnostics Forum—consensus statement on the development and implementation of molecular diagnostic tests in the United Kingdom
2019
Overview
Background
Pathology has evolved from a purely morphological description of cellular alterations in disease to our current ability to interrogate tissues with multiple ‘omics’ technologies. By utilising these techniques and others, ‘molecular diagnostics’ acts as the cornerstone of precision/personalised medicine by attempting to match the underlying disease mechanisms to the most appropriate targeted therapy.
Methods
Despite the promises of molecular diagnostics, significant barriers have impeded its widespread clinical adoption. Thus, the National Cancer Research Institute (NCRI) Cellular Molecular Pathology (CM-Path) initiative convened a national Molecular Diagnostics Forum to facilitate closer collaboration between clinicians, academia, industry, regulators and other key stakeholders in an attempt to overcome these.
Results
We agreed on a consensus ‘roadmap’ that should be followed during development and implementation of new molecular diagnostic tests. We identified key barriers to efficient implementation and propose possible solutions to these. In addition, we discussed the recent reconfiguration of molecular diagnostic services in NHS England and its likely impacts.
Conclusions
We anticipate that this consensus statement will provide practical advice to those involved in the development of novel molecular diagnostic tests. Although primarily focusing on test adoption within the United Kingdom, we also refer to international guidelines to maximise the applicability of our recommendations.
Publisher
Nature Publishing Group UK
