Strategic Issues in the Adoption of Genome-Based Diagnostics
作者： Myla Lai-Goldman , Hawazin Faruki
DOI: 10.1016/B978-0-12-382227-7.00040-9
关键词:
摘要: The assimilation of new genomic-based diagnostic capabilities into routine medical practice will undoubtedly have a profound impact on patient management decisions. However, the challenge translating newly discovered biomarkers widely utilized applications remains. This chapter discuss many technical, regulatory, and financial challenges to full adoption genomic tests in clinic, delineate some key drivers test acceptance along continuum from early discovery utilization.
sci-hub.se 参考文章(21)
C. Bokemeyer, I. Bondarenko, J. T. Hartmann, F. G. De Braud, C. Volovat, J. Nippgen, C. Stroh, I. Celik, P. Koralewski, KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: The OPUS experience Journal of Clinical Oncology. ,vol. 26, pp. 4000- 4000 ,(2008) , 10.1200/JCO.2008.26.15_SUPPL.4000
David R. Holmes, Gregory J. Dehmer, Sanjay Kaul, Dana Leifer, Patrick T. O’Gara, C. Michael Stein, ACCF/AHA Clopidogrel Clinical Alert: Approaches to the FDA “Boxed Warning”: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents and the American Heart Association Endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons Journal of the American College of Cardiology. ,vol. 56, pp. 321- 341 ,(2010) , 10.1016/J.JACC.2010.05.013
Jessica L. Mega, Sandra L. Close, Stephen D. Wiviott, Lei Shen, Richard D. Hockett, John T. Brandt, Joseph R. Walker, Elliott M. Antman, William Macias, Eugene Braunwald, Marc S. Sabatine, Cytochrome P-450 Polymorphisms and Response to Clopidogrel The New England Journal of Medicine. ,vol. 360, pp. 354- 362 ,(2009) , 10.1056/NEJMOA0809171
F Di Fiore, F Blanchard, F Charbonnier, F Le Pessot, A Lamy, M P Galais, L Bastit, A Killian, R Sesboüé, J J Tuech, A M Queuniet, B Paillot, J C Sabourin, F Michot, P Michel, T Frebourg, Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. British Journal of Cancer. ,vol. 96, pp. 1166- 1169 ,(2007) , 10.1038/SJ.BJC.6603685
L M Hinman, S-M Huang, J Hackett, W H Koch, P Y Love, G Pennello, A Torres-Cabassa, C Webster, The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop. Pharmacogenomics Journal. ,vol. 6, pp. 375- 380 ,(2006) , 10.1038/SJ.TPJ.6500392
Myla Lai-Goldman, Hawazin Faruki, Abacavir hypersensitivity: a model system for pharmacogenetic test adoption Genetics in Medicine. ,vol. 10, pp. 874- 878 ,(2008) , 10.1097/GIM.0B013E31818DE71C
Hawazin Faruki, Myla Lai-Goldman, Application of a pharmacogenetic test adoption model to six oncology biomarkers. Personalized Medicine. ,vol. 7, pp. 441- 450 ,(2010) , 10.2217/PME.10.37
Subhashini Chandrasekharan, Melissa Fiffer, Impact of gene patents and licensing practices on access to genetic testing for hearing loss Genetics in Medicine. ,vol. 12, pp. S171- S193 ,(2010) , 10.1097/GIM.0B013E3181D7B053
John H Barton, Emerging patent issues in genomic diagnostics Nature Biotechnology. ,vol. 24, pp. 939- 941 ,(2006) , 10.1038/NBT0806-939
Louis M. Solomon, Gregory J. Sieczkiewicz, Impact of the US Patent System on the Promise of Personalized Medicine Gender Medicine. ,vol. 4, pp. 187- 192 ,(2007) , 10.1016/S1550-8579(07)80039-8