References
- United States Food and Drug Administration: Companion diagnostics. 07/31/2014 [cited; Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitro Diagnostics/ucm407297.htm
- Food and Drug Administration. Guidance for industry and food and drug administration staff: in vitro companion diagnostic devices. 2014.
- Nagai S, Urata M, Sato H, Mikami M, Kuga W, Yanagihara R, Miyamoto D, Suzuki Y, Shikano M. Evolving Japanese regulations on companion diagnostics. Nat Biotechnol 2016;34:141–4.
- Pignatti F, Ehmann F, Hemmings R, Jonsson B, Nuebling M, Papaluca-Amati M, Posch M, Rasi G. Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union. Clin Cancer Res J Am Assoc Cancer Res 2014;20:1458–68.
- Khoury JD, Catenacci DV. Next-generation companion diagnostics: promises, challenges, and solutions. Arch Pathol Lab Med 2015;139:11–13.
- Abrams J, Conley B, Mooney M, Zwiebel J, Chen A, Welch JJ, Takebe N, Malik S, McShane L, Korn E, Williams M, Staudt L, Doroshow J. National Cancer Institute’s Precision Medicine Initiatives for the new National Clinical Trials Network. Am Soc Clin Oncol Educ Book 2014;71–6.
- Luo D, Smith JA, Meadows NA, Schuh A, Manescu KE, Bure K, Davies B, Horne R, Kope M, DiGiusto DL, Brindley DA. A quantitative assessment of factors affecting the technological development and adoption of companion diagnostics. Front Genet 2015;6:357.
- Doble B, Tan M, Harris A, Lorgelly P. Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist. Expert Rev Mol Diagn 2015;15:235–54.
- Zaric GS. Cost implications of value-based pricing for companion diagnostic tests in precision medicine. Pharmacoeconomics 2016;34:635–44.
- Gruver AM, Schade AE. Advanced companion diagnostics facilities: opportunity favors the prepared laboratory. Arch Pathol Lab Med 2015;139:1201.
- Rocken C. Quality assurance in clinical trials-the role of pathology. Virchows Arch 2016;468:83–92.
- Fayanju OM, Mayo TL, Spinks TE, Lee S, Barcenas CH, Smith BD, Giordano SH, Hwang RF, Ehlers RA, Selber JC, Walters R, Tripathy D, Hunt KK, Buchholz TA, Feeley TW, Kuerer HM. Value-based breast cancer care: a multidisciplinary approach for defining patient-centered outcomes. Ann Surg Oncol 2016;23:2385–90.
- Lewis CM, Nurgalieva Z, Sturgis EM, Lai SY, Weber RS. Improving patient outcomes through multidisciplinary treatment planning conference. Head Neck 2015;38 Suppl 1:E1820–5.
- Brower V. NCI-MATCH pairs tumor mutations with matching drugs. Nat Biotechnol 2015;33:790–1.