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Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health.

The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence.

Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups.

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Suggested Citation

Institute of Medicine. 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press. https://doi.org/10.17226/13133.

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Publication Info

106 pages |  6 x 9 | 

ISBNs: 
  • Paperback:  978-0-309-21104-8
  • Ebook:  978-0-309-21107-9
DOI: https://doi.org/10.17226/13133
Chapters skim
Front Matter i-xx
1 Introduction 1-4
2 Stakeholder Perspectives on Evidence 5-24
3 Approaches to Evidence Generation 25-42
4 Overcoming Barriers for Evidence Generation 43-52
5 Considerations Moving Forward 53-58
6 Final Remarks 59-62
References 63-66
Appendix A: Workshop Agenda 67-70
Appendix B: Speaker Biographical Sketches 71-80
Appendix C: Registered Attendees 81-86

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