Skip to main content

Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary

View Cover

Genome-Based Diagnostics

Demonstrating Clinical Utility in Oncology: Workshop Summary (2013)
Purchase Options
Purchase Options MyNAP members save 10% online. Login or Register
Overview

Contributors

Description

Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology is the summary of a workshop convened in May 2012 by the Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy of the Institute of Medicine to foster the identified need for further sustained dialogue between stakeholders regarding the clinical utility of molecular diagnostics. The workshop brought together a wide range of stakeholders, including patients, health care providers, policy makers, payers, diagnostic test developers, researchers, and guideline developers, to identify the challenges and opportunities in advancing the development and use of molecular diagnostic tests designed to guide the treatment and management of patients with cancer.

The sequencing of the human genome has greatly accelerated the process of linking specific genetic variants with disease. These findings have yielded a rapidly increasing number of molecular diagnostic tests designed to guide disease treatment and management. Many of these tests are aimed at determining the best treatments for specific forms of cancer, making oncology a valuable testing ground for the use of molecular diagnostic tests in medicine in general. Nevertheless, many questions surround the clinical value of molecular diagnostic tests, and their acceptance by clinicians, payers, and patients has been unpredictable. A major limiting factor for the use of these tests has been the lack of clear evidence of clinical utility. Genome-Based Diagnostics assesses the evidentiary requirements for clinical utility of molecular diagnostics used to guide treatment decisions for patients with cancer; discusses methodologies related to demonstrating these evidentiary requirements that meet the needs of all stakeholders; and considers innovative, sustainable research collaborations for generating evidence of clinical utility involving multiple stakeholders.

Topics

Suggested Citation

Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. https://doi.org/10.17226/18275.

Import this citation to:

Publication Info

122 pages | 6 x 9
ISBNs:
  • Paperback: 978-0-309-26959-9
  • Ebook: 978-0-309-26963-6
DOI: https://doi.org/10.17226/18275
Contents
Rights

Copyright Information

The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:

  • Republish or display in another publication, presentation, or other media
  • Use in print or electronic course materials and dissertations
  • Share electronically via secure intranet or extranet
  • And more

For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.

Click here to obtain permission for Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary.

Translation and Other Rights

For information on how to request permission to translate our work and for any other rights related query please click here.

Copyright.com Customer Service

For questions about using the Copyright.com service, please contact:

Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
E-mail: info@copyright.com
Web: https://www.copyright.com
Stats

Loading stats for Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary...