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Suggested Citation:"References." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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References

AMA (American Medical Association). 2011. Request for molecular pathology code review and feedback. http://www.ama-assn.org/ama1/pub/upload/mm/362/request-for-molecular-pathology-code-review-and-feedback.pdf (accessed February 2, 2012).

Andriole, G. L., E. D. Crawford, R. L. Grubb, III, S. S. Buys, D. Chia, T. R. Church, M. N. Fouad, E. P. Gelmann, P. A. Kvale, D. J. Reding, J. L. Weissfeld, L. A. Yokochi, B. O’Brien, J. D. Clapp, J. M. Rathmell, T. L. Riley, R. B. Hayes, B. S. Kramer, G. Izmirlian, A. B. Miller, P. F. Pinsky, P. C. Prorok, J. K. Gohagan, and C. D. Berg, for the PLCO Project Team. 2009. Mortality results from a randomized prostate-cancer screening trial. New England Journal of Medicine 360(13):1310-1319.

Buyse, M., S. Loi, L. van ‘t Veer, G. Viale, M. Delorenzi, A. M. Glas, M. S. d’Assignies, J. Bergh, R. Lidereau, P. Ellis, A. Harris, J. Bogaerts, P. Therasse, A. Floore, M. Amakrane, F. Piette, E. Rutgers, C. Sotiriou, F. Cardoso, and M. J. Piccart. 2006. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. Journal of the National Cancer Institute 98(17):1183-1192.

CMS (Center for Medicare & Medicaid Services). 2012. Summary of policies in the calendar year 2012 medicare physician fee schedule final rule and the telehealth originating site facility fee payment amount. MLN Matters MM7671.

Fisher, B., J. Dignam, N. Wolmark, A. DeCillis, B. Emir, D. L. Wickerham, J. Bryant, N. V. Dimitrov, N. Abramson, J. N. Atkins, H. Shibata, L. Deschenes, and R. G. Margolese. 1997. Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer. Journal of the National Cancer Institute 89(22):1673-1682.

IOM (Institute of Medicine). 2011a. Establishing precompetitive collaborations to stimulate genomics-driven product development: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2011b. Generating evidence for genomic diagnostic test development: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012. Evolution of translational omics: Lessons learned and the path forward. Washington, DC: The National Academies Press.

Suggested Citation:"References." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×

Meyers, M. F. 2011. Health care providers and direct-to-consumer access and advertising of genetic testing in the United States. Genome Medicine 3(12):81.

NIH (National Institutes of Health). 2010. NIH announces genetic testing registry. http://www.nih.gov/news/health/mar2010/od-18.htm (accessed February 2, 2012).

NVCA (National Venture Capital Association). 2011a. Venture impact: The economic importance of venture capital-backed companies to the U.S. economy. www.nvca.org/index.php?option=com_docman&task (accessed March 19, 2012).

NVCA. 2011b. Vital signs: The crisis in investment in U.S. medical innovation and the imperative of FDA reform. www.nvca.org/vital_signs_data_slides.pdf (accessed March 19, 2012).

NVCA. 2011c. Yearbook. New York: Thomson Reuters.

Peterson, C., and R. Burton. 2007. U.S. health care spending: Comparison with other OECD countries. Paper 311, Congressional Research Service.

SACGHS (Secretary’s Advisory Committee on Genetics, Health, and Society). 2008. U.S. system of oversight of genetic testing: A response to the charge of the Secretary of Health and Human Services. Bethesda, MD: Department of Health and Human Services.

Schully, S. D., C. B. Benedicto, E. M. Gillanders, S. S. Wang, and M. J. Khoury. 2011. Translational research in cancer genetics: The road less traveled. Public Health Genomics 14(1):1-8.

Siegel, R., D. Naishadham, and A. Jemal. 2012. Cancer statistics, 2012. CA: A Cancer Journal for Clinicians 62(1):10-29.

Simon, R. M., S. Park, and D. F. Hayes. 2009. Use of archived specimens in evaluation of prognostic and predictive biomarkers. Journal of the National Cancer Institute 101(21): 1446-1452.

Slamon, D. J., B. Leyland-Jones, S. Shak, H. Fuchs, V. Paton, A. Bajamonde, T. Fleming, W. Eiermann, J. Wolter, M. Pegram, J. Baselga, and L. Norton. 2001. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. New England Journal of Medicine 344(11):783-792.

SSAB (Social Security Advisory Board). 2009. The unsustainable cost of health care. http://www.ssab.gov/documents/TheUnsustainableCostofHealthCare_508.pdf (accessed January 26, 2012).

Teutsch, S. M., L. A. Bradley, G. E. Palomaki, J. E. Haddow, M. Piper, N. Calonge, W. D. Dotson, M. P. Douglas, A. O. Berg, and EGAPP Working Group. 2009. The evaluation of genomic applications in practice and prevention (EGAPP) initiative: Methods of the EGAPP working group. Genetic Medicine 11(1):3-14.

Thygesen, K., J. Mair, H. Katus, M. Plebani, P. Venge, P. Collinson, B. Lindahl, E. Giannitsis, Y. Hasin, M. Galvani, M. Tubaro, J. S. Alpert, L. M. Biasucci, W. Koenig, C. Mueller, K. Huber, C. Hamm, and A. S. Jaffe. 2010. Recommendations for the use of cardiac troponin measurement in acute cardiac care. European Heart Journal 31(18):2197-2204.

USPSTF (U.S. Preventive Services Task Force). 2005. Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility: Recommendation statement. Annals of Internal Medicine 143(5):355-361.

West, D. M. 2011. Enabling personalized medicine through health information technology: Advancing the integration of information. http://www.brookings.edu/papers/2011/0128_personalized_medicine_west.aspx (accessed February 2, 2012).

Wright, C. F., and M. Kroese. 2009. Evaluation of genetic tests for susceptibility to common complex diseases: Why, when and how? Human Genetics 127(2):125-134.

Suggested Citation:"References." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
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Page 61
Suggested Citation:"References." Institute of Medicine. 2012. Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13359.
×
Page 62
Next: Appendix A: Workshop Agenda »
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The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients. However, the adoption of genomic diagnostic tests by health care providers has been limited due to a lack of evidence regarding the clinical utility of many tests. 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. The Roundtable on Translating Genomic-Based Research for Health held a workshop in November 2010 to determine what evidence is needed and how it is viewed by different stakeholders in order to develop genomic diagnostic tests of clinical value.

Genome-Based Diagnostics summarizes the presentations and discussions that took place throughout the workshop. Two presentations, in particular, sparked extensive discussion. One presentation proposed that all genomic diagnostic tests be reviewed and approved by the Food and Drug Administration. The other observed that venture capitalists are no longer investing substantially in the development of genomic diagnostic tests because of a lack of clarity surrounding regulatory and reimbursement pathways. Both presentations suggested the need for major changes in the systems used to develop, regulate, and reimburse genomic diagnostic tests. The report also presents the perspectives of different stakeholders in the development of genomic diagnostic tests. Each stakeholder group has a different set of needs and issues of importance, yet commonalities among them are apparent, such as the need to put patients and health outcomes at the center of discussion and action.

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