Facilitating Development and Utilization of Genome-Based Diagnostic Technologies: A Workshop
- When:
- November 15, 2011 (8:30 AM Eastern)
- Where:
- Keck Center (100) • 500 Fifth St. NW, Washington, DC 20001 Map
- Topics:
- Biomedical and Health Research, Public Health
- Activity:
- Roundtable on Translating Genomic-Based Research for Health
- Board:
- Board on Health Sciences Policy
The sequencing of the human genome and the identification of links between specific genetic variants and disease formation have led to an explosion of genomics-based diagnostic tests. These tests have the potential to direct therapeutic interventions or predict onset of disease. As research progresses and an increasing number of linkages are found, further tests will be developed which can aid in providing personalized treatment options for patients.
However, the current adoption of genomic diagnostic tests into practice by providers has been limited due to a lack of evidence of clinical utility. Thus, health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. In part, this lack of evidence and usage has led to what has been termed a “vicious cycle” of undervaluation, with test developers producing either no or low evidence of clinical utility, followed by limited usage by providers and little reimbursement by payers. This undervaluation by all groups results in limited resources for developers to produce the evidence desired by various stakeholders and a perpetual continuation of the cycle.
The Roundtable on Translating Genomic-Based Research for Health will host a workshop to examine potential solutions for advancing the development of clinically useful genomics-based diagnostic tests. The presentations and discussions will explore the current challenges, such as commercial considerations, regulatory policy, and evidence of clinical utility, and identify potential opportunities to advance the development and use of genomic diagnostic tests. Stakeholders including diagnostic test developers, payers, policy makers, health care providers, patient advocacy groups, and others will be invited to present their perspectives.
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