Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary

Excerpt

A major impediment to the integration of these genomic tests into routine health care is the lack of an adequate evidence base linking the use of genomic diagnostic tests to health outcomes. Since these new technologies are beginning to play an increased role in clinical decision-making and the management of disease, the Institute of Medicine's Roundtable on Translating Genomic-Based Research for Health hosted a public workshop on November 17, 2010, to explore issues related to this lack of evidence. Various stakeholders, including regulators and policymakers, payers, healthcare providers, researchers, funders, and evidence-based review groups, were invited to share their perspectives on the strengths and limitations of the evidence being generated to assess the clinical validity and utility of genomic diagnostic tests. Specifically, panelists were asked to address the following:

1. What evidence is required by stakeholders (e.g., for decisions regarding clearance, use, and reimbursement)?

2. How is evidence currently being generated?

3. Are there innovative and efficient ways to generate high-quality evidence?

4. How can the barriers to generating this evidence be overcome?