Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary (2012)
Chapter: Appendix C: Statement of Task
An ad hoc planning committee will plan and conduct a public workshop that will examine methods for accelerating the approval and adoption of genomic diagnostic tests. The workshop will feature presentations and discussions from an array of stakeholders which may include providers, payers, guideline developers, diagnostic device developers, product reviewers, patients, and regulators. The goal of the workshop will be to advance discussions among policymakers and the broader public on the current challenges which are limiting the development and utilization of diagnostic tests, such as commercial considerations, regulatory policy, and evidence of clinical utility. The planning committee will develop the workshop agenda, select and invite speakers and discussants, and moderate the discussions. An individually-authored summary of the workshop will be prepared by a designated rapporteur in accordance with institutional policy and procedures.
