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Barriers to the Development and Utilization of Genome-Based Diagnostic Technologies: A Workshop

Completed

Topics

The number of genome-based diagnostic tests that have the potential to predict onset of disease or direct drug therapy has steadily increased as improved gene-disease relationships have been identified. However, few have been adopted for use in a health care setting. Given the current challenges, this workshop focused on identifying potential solutions in reimbursement policy, regulatory policy, and generating evidence of clinical utility to advance the development of clinically useful genomics-based diagnostic tests.

About Past Events

Description

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.

Collaborators

Sponsors

Department of Health and Human Services

Other, Federal

Private: For Profit

Private: Non Profit

Staff

Adam Berger

Lead

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