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The allure of the emerging genomic technologies in cancer istheir ability to generate new biomarkers that predict how individualcancer patients will respond to various treatments. However,productive implementation of cancer biomarkers into patientcare will require fundamental changes in how we consider approvalsfor cancer indications and how we track patient responses. Herewe briefly describe ongoing efforts to identify and to validatecancer biomarkers, discuss the technological hurdles that lieahead, and then focus on the more pressing political and culturalissues that, if left unheeded, could derail many of the anticipatedbenefits of biomarker research.
1 H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL 33613, USA. 2 Merck Research Laboratories, West Point, PA 19846, USA.
* To whom correspondence should be addressed. E-mail: dalton{at}moffitt.usf.edu (W.S.D.); stephen_friend{at}merck.com (S.H.F.)
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