Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary

by Institute of Medicine, Board on Health Sciences Policy, Roundtable on Translating Genomic-Based Research for Health

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.

106 pages, Paperback

First published June 27, 2011

About the author

The National Academy of Medicine (NAM, formerly the Institute of Medicine-IOM) is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Sciences (NAS), National Academy of Engineering (NAE), and the National Research Council (NRC).

The National Academy of Medicine provides national advice on issues relating to biomedical science, medicine, and health, and serves as an adviser to the nation to improve health aims to provide unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.

Operating outside the framework of the U.S. federal government, it relies on a volunteer workforce of scientists and other experts, operating under a formal peer-review system. As a national academy, new members of the organization are elected annually by current members, based on their distinguished and continuing achievements in a relevant field as well as for their willingness to participate actively.