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References ACOG (American College of Obstetricians and Gynecologists Committee on Genetics). 2011. ACOG committee opinion no. 486: Update on carrier screening for cystic fibrosis. bstetrics & Gynecology 117(4):1028–1031. O Anderson, S., K. J. Bloom, D. U. Vallera, J. Rueschoff, C. Meldrum, R. Schilling, B. Kovach, J. R. Lee, P. Ochoa, R. Langland, H. Halait, H. J. Lawrence, and M. C. Dugan. 2012. Multisite analytic performance studies of a real-time polymerase chain reaction assay for the detection of BRAF V600E mutations in formalin-fixed, paraffin-embedded tissue specimens of malignant melanoma. Archives of Pathology & Laboratory Medicine 136(11):1385–1391. Beau-Faller, M., A. Degeorges, E. Rolland, M. Mounawar, M. Antoine, V. Poulot, A. M auguen, V. Barbu, F. Coulet, J. L. Pretet, I. Bieche, H. Blons, J. C. Boyer, M. P. Buisine, F. de Fraipont, S. Lizard, S. Olschwang, P. Saulnier, D. Prunier-Mirebeau, N. Richard, C. Danel, E. Brambilla, C. Chouaid, G. Zalcman, P. Hainaut, S. Michiels, and J. Cadranel. 2011. Cross-validation study for epidermal growth factor receptor and KRAS mutation detection in 74 blinded non-small cell lung carcinoma samples: A total of 5550 exons sequenced by 15 molecular French laboratories (evaluation of the EGFR mutation tatuss for the administration of EGFR-TKIs in non-small cell lung carcinoma [ERMETIC] project—part 1). Journal of Thoracic Oncology 6(6):1006–1015. Bellon, E., M. J. Ligtenberg, S. Tejpar, K. Cox, G. de Hertogh, K. de Stricker, A. Edsjo, V. Gorgoulis, G. Hofler, A. Jung, A. Kotsinas, P. Laurent-Puig, F. Lopez-Rios, T. P. Hansen, E. Rouleau, P. Vandenberghe, J. J. van Krieken, and E. Dequeker. 2011. External quality assessment for KRAS testing is needed: Setup of a European program and report of the first joined regional quality assessment rounds. Oncologist 16(4):467–478. Brawley, O. W., and P. Goldberg. 2012. How we do harm: A doctor breaks ranks about being sick in America. 1st ed. New York: St. Martin’s Press. Cheng, S., W. H. Koch, and L. Wu. 2012. Co-development of a companion diagnostic for targeted cancer therapy. New Biotechnology 29(6):682–688. Chiang, A., and R. P. Million. 2011. Personalized medicine in oncology: Next generation. Nature Reviews Drug Discovery 10(12):895–896. 55
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56 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT CMS (Centers for Medicare & Medicaid Services). 2013. Forecast summary. Major findings for national health expenditures: 2012–2022. http://www.cms.gov/Research-Statistics- Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/ Proj2012.pdf (accessed September 20, 2013). Davis, P. B., U. Yasothan, and P. Kirkpatrick. 2012. Ivacaftor. Nature Reviews Drug Discovery 11(5):349–350. Dequeker, E., M. J. Ligtenberg, S. Vander Borght, and J. H. van Krieken. 2011. Mutation analysis of KRAS prior to targeted therapy in colorectal cancer: Development and evalu- ation of quality by a European external quality assessment scheme. Virchows Archiv 459(2):155–160. DiMasi, J. A., R. W. Hansen, and H. G. Grabowski. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22(2):151–185. Eichler, H. G., B. Bloechl-Daum, E. Abadie, D. Barnett, F. Konig, and S. Pearson. 2010. Rela- tive efficacy of drugs: An emerging issue between regulatory agencies and third-party payers. Nature Reviews Drug Discovery 9(4):277–291. FDA (U.S. Food and Drug Administration). 2011. Guidance for industry and Food and Drug Administration Staff—in vitro companion diagnostic devices. http://www.fda. gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262292.htm (accessed October 24, 2013). Gonzalez de Castro, D., B. Angulo, B. Gomez, D. Mair, R. Martinez, A. Suarez-Gauthier, F. Shieh, M. Velez, V. H. Brophy, H. J. Lawrence, and F. Lopez-Rios. 2012. A comparison of three methods for detecting kras mutations in formalin-fixed colorectal cancer speci- mens. British Journal of Cancer 107(2):345–351. Halait, H., K. Demartin, S. Shah, S. Soviero, R. Langland, S. Cheng, G. Hillman, L. Wu, and H. J. Lawrence. 2012. Analytical performance of a real-time PCR-based assay for V600 mutations in the BRAF gene, used as the companion diagnostic test for the novel BRAF inhibitor vemurafenib in metastatic melanoma. Diagnostic Molecular Pathology 21(1):1–8. Longshore, J. W., H. Amidon, H. N. Todd, J. Fu, M. Christensen, J. Tsai, G. Hillman, H. Halait, F. Shieh, J. Lawrence, E. Lipford. 2012. A methods comparison analysis of the Roche cobas 4800 BRAF V600 mutation test and the Qiagen BRAF RGQ PCR kit on melanoma specimens with challenging attributes. Journal of Molecular Diagnostics 14(6):716. Moore, M. W., D. Babu, and P. D. Cotter. 2012. Challenges in the co-development of com panion diagnostics. Personalized Medicine 9(5):485–496. Quinn, B. 2010. Payers and the assessment of clinical utility for companion diagnostics. linical Pharmacology & Therapeutics 88(6):751–754. C van Krieken, J. H., N. Normanno, F. Blackhall, E. Boone, G. Botti, F. Carneiro, I. Celik, F. Ciardiello, I. A. Cree, Z. C. Deans, A. Edsjo, P. J. Groenen, O. Kamarainen, H. H. Kreipe, M. J. Ligtenberg, A. Marchetti, S. Murray, F. J. Opdam, S. D. Patterson, S. P atton, C. Pinto, E. Rouleau, E. Schuuring, S. Sterck, M. Taron, S. Tejpar, W. Timens, E. Thunnissen, P. M. van de Ven, A. G. Siebers, and E. Dequeker. 2013. Guideline on the requirements of external quality assessment programs in molecular pathology. Virchows Archiv 462(1):27–37.