Genome-Based Diagnostics Demonstrating Clinical Utility in Oncology: Workshop Summary (2013) / Chapter Skim
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1 Introduction
1 Introduction
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Capturing the benefits of molecular diagnostics will require stakeholders to help shape and define methodologies for efficiently generating reliable information about which tests will improve health outcomes for patients. Sustained dialogue among stakeholders is needed to help close the current 1 The planning committee's role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.
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Finally, McCormack said, the workshop demonstrated that the full picture is much bigger than most stakeholders imagine. The challenge of establishing clinical utility extends throughout the diagnostic discovery and development process, encompassing not only evidence development but also reimbursement and regulatory hurdles.
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THE CURRENT EFFORT On May 24, 2012, the Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy cohosted a workshop in Washington, DC, to foster the identified need for further sustained dialogue between stakeholders regarding the clinical utility of molecular diagnostics. Titled Evidence for Clinical Utility of Molecular Diagnostics in Oncology, the workshop brought together a wide range of stakeholders, including patients, health care providers, policy makers, payers, diagnostic test developers, researchers, and guideline developers, to identify the challenges and opportunities in advancing the development and use of molecular diagnostic tests designed to guide the treatment and management of patients with cancer.2 Box 1-1 lists the goals of the workshop.
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The role of establishing successful partnerships to overcome challenges encountered during test development and the importance of the availability of biospecimens and data are discussed. This final chapter also provides a summary of the proposals suggested by individual speakers to advance the development of clinical utility measures for molecular diagnostics.
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