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[116] Breccia M, Alimena G. Nilotinib: a second-generation tyrosine kinase inhibitor for chronic myeloid leukemia.
Leuk Res 2010;34:129-34.
[117] Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, et al. Circulating tumor cells, disease pro-
gression, and survival in metastatic breast cancer. N Engl J Med 2004;351:781-91.
[118] Somlo G, Lau SK, Frankel P, Hsieh HB, Liu X, Yang L, et  al. Multiple biomarker expression on circulat-
ing tumor cells in comparison to tumor tissues from primary and metastatic sites in patients with locally
advanced / inlammatory, and stage IV breast cancer, using a novel detection technology. Breast Cancer Res
Treat 2011;128:155-63.
[119] Nagrath S, Sequist LV, Maheswaran S, Bell DW, Irimia D, Ulkus L, et  al. Isolation of rare circulating tumor
cells in cancer patients by microchip technology. Nature 2007;450:1235-9.
[120] Philip R, Carrington L, Chan. M. US FDA perspective on challenges in co-developing in vitro companion
diagnostics and targeted cancer therapeutics. Bioanalysis 2011;3(4):383-9.
[121] Draft Guidance for Industry and Food and Drug Administration Staff - In vitro Companion Diagnostic
Devices. Available from: < http: // www.fda.gov / medicaldevices / deviceregulationandguidance / guidancedocu-
ments / ucm262292htm > , accessed March 2013.
[122] Guideline for the manufacture of in vitro diagnostic products - food and drug administration center for
devices and radiological health office of compliance. Available from: < http: // www.fda.gov / downloads / medi-
caldevices / deviceregulationandguidance / guidancedocuments / ucm079101.pdf > , accessed March 2013.
[123] Moschos SA. Genomic biomarkers for patient selection and stratiication: the cancer paradigm. Bioanalysis
2012;4(20):2499-511.
[124] Zieba A, Grannas K, Soderberg O, Gullberg M, Nilsson M, Landegren U. Molecular tools for companion
diagnostics. N Biotechnol 2012;29:6.
[125] Hodgson DR, Whittaker RD, Herath A, Amakye D, Clack G, Biomarkers in oncology drug development. Mol
Oncol 2009;3:24-32.
[126] Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein Jr GR, Tsao A, et  al. The BATTLE Trial: personalizing
therapy for lung cancer. Cancer Discov 2011;1:1.
[127] Rubin EH, Anderson KM, Gause CK. The BATTLE Trial: a bold step toward improving the eficiency of bio-
marker-based drug development. Cancer Discov 2011;1:17-20.
[128] Sequist LV, Muzikansky A, Engelman JA. A new BATTLE in the evolving war on cancer. Cancer Discov
2011;1:14-16.
[129] Kris M. Identiication of drive mutations in tumor specimens from 1,000 patients with lung adenocarcinoma:
The NCI's lung cancer mutation consortium. 2011 ASCO annual meeting. J Clin Oncol 2011:29 (June 20 Suppl.).
[130] US FDA. Table of pharmacogenomic biomarkers in drug labels. < www.fda.gov / Drugs / ScienceResearch /
ResearchAreas / Pharmacogenetics / ucm083378.htm > , accessed March 2013.
[131] Chmielecki J, Peifer M, Jia P, Socci ND, Hutchinson K, Viale A, et  al. Targeted next-generation sequencing
of DNA regions proximal to a conserved GXGXXG signaling motif enables systematic discovery of tyrosine
kinase fusions in cancer. Nucleic Acids Res 2010;38(20):6985-96.
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