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Evidence Generation for Genomic Diagnostic Test Development: A Workshop

Completed

This public workshop examined evidence generation for genomic diagnostic test development and explored the evidence needed to determine clinical utility, the study requirements that can help generate this evidence, and the necessary funding mechanisms to support this research to help advance discussions amongst policymakers and the broader public.

Description

An ad hoc committee will plan and conduct a public workshop that will examine evidence generation for genomic diagnostic test development. An array of stakeholder perspectives will be included in this activity; stakeholders may include payers, patient advocacy groups, policy makers, public health professionals, health care providers, laboratory test developers, and clinical investigators. The workshop will feature presentations and discussions to rigorously explore the strengths and limitations of the evidence that is being generated for clinical utility. The goal of the workshop will be to identify important issues surrounding genomic diagnostic test development, such as the evidence which is required from various stakeholders to determine clinical utility, the study requirements needed to generate this evidence, and the necessary funding mechanisms to support this research, to help advance discussions amongst policymakers and the broader public. 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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