National Academy of Medicine

Clinical Utility: Informing Treatment Decisions by Changing the Paradigm

By Robert T. McCormack, Paul R. Billings
January 29, 2015 | Discussion Paper

Next-generation sequencing has provided significant insight into the basic biology of cancer, allowing for the development of new targeted therapeutics and the identification of biomarkers that can direct treatment course. However, the evidence needed to demonstrate that next-generation sequencing-based tests lead to clinical decisions that improve outcomes can be challenging for test developers and laboratories to generate. This discussion paper, the third of seven individually authored commentaries that explores the evidence needed to support the use of genome sequencing in the clinic, examines the challenges involved in and opportunities for demonstrating the clinical utility of a next-generation sequencing-based test.

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Disclaimer: The views expressed in this paper are those of the authors and not necessarily of the authors’ organizations, the National Academy of Medicine (NAM), or the National Academies of Sciences, Engineering, and Medicine (the National Academies). The paper is intended to help inform and stimulate discussion. It is not a report of the NAM or the National Academies. Copyright by the National Academy of Sciences. All rights reserved.