On best practices: The Institute of Medicine scheme for developing, validating, and demonstrating clinical utility of omics‐based diagnostic and predictive tests
dc.contributor.author | Sauer, Sascha | en_US |
dc.date.accessioned | 2014-01-08T20:35:09Z | |
dc.date.available | 2015-02-03T16:14:40Z | en_US |
dc.date.issued | 2013-12 | en_US |
dc.identifier.citation | Sauer, Sascha (2013). "On best practices: The Institute of Medicine scheme for developing, validating, and demonstrating clinical utility of omics‐based diagnostic and predictive tests." PROTEOMICS – Clinical Applications 7(11-12): 748-755. | en_US |
dc.identifier.issn | 1862-8346 | en_US |
dc.identifier.issn | 1862-8354 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/102242 | |
dc.publisher | National Academies Press | en_US |
dc.publisher | Wiley Periodicals, Inc. | en_US |
dc.subject.other | Tests | en_US |
dc.subject.other | Diagnostics | en_US |
dc.subject.other | Institute of Medicine | en_US |
dc.subject.other | Omics | en_US |
dc.title | On best practices: The Institute of Medicine scheme for developing, validating, and demonstrating clinical utility of omics‐based diagnostic and predictive tests | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/102242/1/prca1506.pdf | |
dc.identifier.doi | 10.1002/prca.201300041 | en_US |
dc.identifier.source | PROTEOMICS – Clinical Applications | en_US |
dc.identifier.citedreference | Farrah, T., Deutsch, E. W., Kreisberg, R., Sun, Z. et al., PASSEL: the PeptideAtlas SRMexperiment library. Proteomics 2012, 12, 1170 – 1175. | en_US |
dc.identifier.citedreference | Simon, R. M., Paik, S., Hayes, D. F., Use of archived specimens in evaluation of prognostic and predictive biomarkers. J. Natl. Cancer Inst. 2009, 101, 1446 – 1452. | en_US |
dc.identifier.citedreference | Potti, A., Dressman, H. K., Bild, A., Riedel, R. F. et al., Genomic signatures to guide the use of chemotherapeutics. Nat. Med. 2006, 12, 1294 – 1300. | en_US |
dc.identifier.citedreference | Baggerly, K. A., Coombs, K. R., Deriving chemosensitivity from cell lines: forensic bioinformatics and reproducible research in high‐throughput biology. Ann. Appl. Stat. 2009, 3, 1309 – 1334. | en_US |
dc.identifier.citedreference | Zhang, Z., Chan, D. W., The road from discovery to clinical diagnostics: lessons learned from the first FDA‐cleared in vitro diagnostic multivariate index assay of proteomic biomarkers. Cancer Epidemiol. Biomarkers Prev. 2010, 19, 2995 – 2999. | en_US |
dc.identifier.citedreference | US Food and Drug Adminstration, FDA clears a test for ovarian cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182057.htm. Retrieved May 5, 2011. Accessed August 23, 2013. | en_US |
dc.identifier.citedreference | Zhang, Z., Bast, R. C., Jr., Yu, Y., Li, J. et al., Three biomarkers identified from serum proteomic analysis for the detection of early stage ovarian cancer. Cancer Res. 2004, 64, 5882 – 5890. | en_US |
dc.identifier.citedreference | Fung, E. T., A recipe for proteomics diagnostic test development: the OVA1 test, from biomarker discovery to FDA clearance. Clin. Chem. 2010, 56, 327 – 329. | en_US |
dc.identifier.citedreference | Agency for Healthcare Research and Quality (AHRQ), Genomics test for ovarian cancer detection and management. AHRQ, Rockville, MD 2006. | en_US |
dc.identifier.citedreference | Zhang, Z., Chan, D. W., Cancer proteomics: in pursuit of “true” biomarker discovery. Cancer Epidemiol. Biomarkers Prev. 2005, 14, 2283 – 2286. | en_US |
dc.identifier.citedreference | Committee on Assessing Integrity in Research Environments, Integrity in scientific research: creating an environment that promotes responsible conduct. National Academies Press, Washington, DC 2002. | en_US |
dc.identifier.citedreference | National Research Council, International regulatory harmonization amid globalization of drug development: workshop summary. National Academies Press, Washington, DC 2013. | en_US |
dc.identifier.citedreference | Hood, L., Systems biology and p4 medicine: past, present, and future. Rambam Maimonides Med. J. 2013, 4, e0012. | en_US |
dc.identifier.citedreference | Roychowdhury, S., Iyer, M. K., Robinson, D. R., Lonigro, R. J. et al., Personalized oncology through integrative high‐throughput sequencing: a pilot study. Sci. Transl. Med. 2011, 3, 111ra121. | en_US |
dc.identifier.citedreference | Roychowdhury, S., Chinnaiyan, A. M., Advancing precision medicine for prostate cancer through genomics. J. Clin. Oncol. 2013, 31, 1866 – 1873. | en_US |
dc.identifier.citedreference | Hayes, D. F., Allen, J., Compton, C., Gustavsen, G. et al., Breaking a vicious cycle. Sci. Transl. Med. 2013, 5, 196cm196. | en_US |
dc.identifier.citedreference | National Research Council, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy Of Disease, National Academies Press, Washington, DC 2011. | en_US |
dc.identifier.citedreference | Omenn, G. S., in: Ginsgburg, G. S., Willard, H. F. (Eds.), Genomic and Personalized Medicine, Elsevier, New York 2012, pp. 50 – 59. | en_US |
dc.identifier.citedreference | Micheel, C. C., Nass, S. J., Omenn, G. S. (Eds.), Evolution of Translational Omics: Lessons Learned and the Path Forward, National Academies Press, Washington, DC 2012. | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
Files in this item
Remediation of Harmful Language
The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.
Accessibility
If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.