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Translational crossroads for biomarkers

Bast, Robert C Jr; Lilja, Hans LU ; Urban, Nicole; Rimm, David L; Fritsche, Herbert; Gray, Joe; Veltri, Robert; Klee, George; Allen, Andrew and Kim, Nam, et al. (2005) In Clinical Cancer Research 11(17). p.6103-6108
Abstract
A group of investigators met at a Specialized Programs of Research Excellence Workshop to discuss key issues in the translation of biomarker discovery to the development of useful laboratory tests for cancer care. Development and approval of several new markers and technologies have provided informative examples that include more specific markers for prostate cancer, more sensitive tests for ovarian cancer, more objective analysis of tissue architecture and an earlier indication of response to treatment in breast cancer. Although there is no clear paradigm for biomarker development, several principles are clear. Marker development should be driven by clinical needs, including early cancer detection, accurate pretreatment staging, and... (More)
A group of investigators met at a Specialized Programs of Research Excellence Workshop to discuss key issues in the translation of biomarker discovery to the development of useful laboratory tests for cancer care. Development and approval of several new markers and technologies have provided informative examples that include more specific markers for prostate cancer, more sensitive tests for ovarian cancer, more objective analysis of tissue architecture and an earlier indication of response to treatment in breast cancer. Although there is no clear paradigm for biomarker development, several principles are clear. Marker development should be driven by clinical needs, including early cancer detection, accurate pretreatment staging, and prediction of response to treatment, as well as monitoring disease progression and response to therapy. Development of a national repository that uses carefully preserved, well-annotated tissue specimens will facilitate new marker development. Reference standards will be an essential component of this process. Both hospital-based and commercial laboratories can play a role in developing biomarkers from discovery to test validation. Partnering of academe and industry should occur throughout the process of biomarker development. The National Cancer Institute is in a unique position to bring together academe, industry, and the Food and Drug Administration to (a) define clinical needs for biomarkers by tumor type, (b) establish analytic and clinical paradigms for biomarker development, (c) discuss ways in which markers from different companies might be evaluated in combination, (d) establish computational methods to combine data from multiple biomarkers, (e) share information regarding promising markers developed in National Cancer Institute-supported programs, and (f) exchange data regarding new platforms and techniques that can accelerate marker development. (Less)
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type
Contribution to journal
publication status
published
subject
in
Clinical Cancer Research
volume
11
issue
17
pages
6103 - 6108
publisher
American Association for Cancer Research
external identifiers
  • pmid:16144908
  • scopus:24344491449
ISSN
1078-0432
DOI
10.1158/1078-0432.CCR-04-2213
language
English
LU publication?
no
id
7620c77e-492b-4fe2-9f97-1d5f10662f7f (old id 1133138)
date added to LUP
2008-06-25 13:50:00
date last changed
2017-01-01 04:56:30
@article{7620c77e-492b-4fe2-9f97-1d5f10662f7f,
  abstract     = {A group of investigators met at a Specialized Programs of Research Excellence Workshop to discuss key issues in the translation of biomarker discovery to the development of useful laboratory tests for cancer care. Development and approval of several new markers and technologies have provided informative examples that include more specific markers for prostate cancer, more sensitive tests for ovarian cancer, more objective analysis of tissue architecture and an earlier indication of response to treatment in breast cancer. Although there is no clear paradigm for biomarker development, several principles are clear. Marker development should be driven by clinical needs, including early cancer detection, accurate pretreatment staging, and prediction of response to treatment, as well as monitoring disease progression and response to therapy. Development of a national repository that uses carefully preserved, well-annotated tissue specimens will facilitate new marker development. Reference standards will be an essential component of this process. Both hospital-based and commercial laboratories can play a role in developing biomarkers from discovery to test validation. Partnering of academe and industry should occur throughout the process of biomarker development. The National Cancer Institute is in a unique position to bring together academe, industry, and the Food and Drug Administration to (a) define clinical needs for biomarkers by tumor type, (b) establish analytic and clinical paradigms for biomarker development, (c) discuss ways in which markers from different companies might be evaluated in combination, (d) establish computational methods to combine data from multiple biomarkers, (e) share information regarding promising markers developed in National Cancer Institute-supported programs, and (f) exchange data regarding new platforms and techniques that can accelerate marker development.},
  author       = {Bast, Robert C Jr and Lilja, Hans and Urban, Nicole and Rimm, David L and Fritsche, Herbert and Gray, Joe and Veltri, Robert and Klee, George and Allen, Andrew and Kim, Nam and Gutman, Steven and Rubin, Mark A and Hruszkewycz, Andrew},
  issn         = {1078-0432},
  language     = {eng},
  number       = {17},
  pages        = {6103--6108},
  publisher    = {American Association for Cancer Research},
  series       = {Clinical Cancer Research},
  title        = {Translational crossroads for biomarkers},
  url          = {http://dx.doi.org/10.1158/1078-0432.CCR-04-2213},
  volume       = {11},
  year         = {2005},
}