References

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

Andriole GL, Crawford ED, Grubb RL III, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O’Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD. for the PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. New England Journal of Medicine. 2009;360(13):1310–1319. [PMC free article: PMC2944770] [PubMed: 19297565]

Buyse M, Loi S, van ‘t Veer L, Viale G, Delorenzi M, Glas AM, d’Assignies MS, Bergh J, Lidereau R, Ellis P, Harris A, Bogaerts J, Therasse P, Floore A, Amakrane M, Piette F, Rutgers E, Sotiriou C, Cardoso F, Piccart MJ. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. Journal of the National Cancer Institute. 2006;98(17):1183–1192. [PubMed: 16954471]

CMS (Center for Medicare & Medicaid Services). 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. 2012. MM7671.

Fisher B, Dignam J, Wolmark N, DeCillis A, Emir B, Wickerham DL, Bryant J, Dimitrov NV, Abramson N, Atkins JN, Shibata H, Deschenes L, Margolese RG. Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer. Journal of the National Cancer Institute. 1997;89(22):1673–1682. [PubMed: 9390536]

IOM (Institute of Medicine). Establishing precompetitive collaborations to stimulate genomics-driven product development: Workshop summary. Washington, DC: The National Academies Press; 2011. [PubMed: 21595119]

IOM. Generating evidence for genomic diagnostic test development: Workshop summary. Washington, DC: The National Academies Press; 2011. [PubMed: 22013612]

IOM. Evolution of translational omics: Lessons learned and the path forward. Washington, DC: The National Academies Press; 2012. [PubMed: 24872966]

Meyers MF. Health care providers and direct-to-consumer access and advertising of genetic testing in the United States. Genome Medicine. 2011;3(12):81. [PMC free article: PMC3334546] [PubMed: 22204616]

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

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

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

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

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

SACGHS (Secretary’s Advisory Committee on Genetics, Health, and Society). US 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; 2008.

Schully SD, Benedicto CB, Gillanders EM, Wang SS, Khoury MJ. Translational research in cancer genetics: The road less traveled. Public Health Genomics. 2011;14(1):1–8. [PMC free article: PMC3025883] [PubMed: 20051673]

Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA: A Cancer Journal for Clinicians. 2012;62(1):10–29. [PubMed: 22237781]

Simon RM, Park S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. Journal of the National Cancer Institute. 2009;101(21):1446–1452. [PMC free article: PMC2782246] [PubMed: 19815849]

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. New England Journal of Medicine. 2001;344(11):783–792. [PubMed: 11248153]

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

Teutsch SM, Bradley LA, Palomaki GE, Haddow JE, Piper M, Calonge N, Dotson WD, Douglas MP, Berg AO. EGAPP Working Group. The evaluation of genomic applications in practice and prevention (EGAPP) initiative: Methods of the EGAPP working group. Genetic Medicine. 2009;11(1):3–14. [PMC free article: PMC2743609] [PubMed: 18813139]

Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P, Lindahl B, Giannitsis E, Hasin Y, Galvani M, Tubaro M, Alpert JS, Biasucci LM, Koenig W, Mueller C, Huber K, Hamm C, Jaffe AS. Recommendations for the use of cardiac troponin measurement in acute cardiac care. European Heart Journal. 2010;31(18):2197–2204. [PubMed: 20685679]

USPSTF (U.S. Preventive Services Task Force. Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility: Recommendation statement. Annals of Internal Medicine. 2005;143(5):355–361. [PubMed: 16144894]

West DM. Enabling personalized medicine through health information technology: Advancing the integration of information. 2011. [accessed February 2, 2012]. http://www​.brookings​.edu/papers/2011/0128​_personalized_medicine_west.aspx.

Wright CF, Kroese M. Evaluation of genetic tests for susceptibility to common complex diseases: Why, when and how? Human Genetics. 2009;127(2):125–134. [PubMed: 19936793]