title: Translational crossroads for biomarkers.
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.
authors.affiliation: University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA. rbast@mdanderson.org
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bast
authors.forename: Hans
authors.initials: H
authors.lastname: Lilja
authors.forename: Nicole
authors.initials: N
authors.lastname: Urban
authors.forename: David L
authors.initials: DL
authors.lastname: Rimm
authors.forename: Herbert
authors.initials: H
authors.lastname: Fritsche
authors.forename: Joe
authors.initials: J
authors.lastname: Gray
authors.forename: Robert
authors.initials: R
authors.lastname: Veltri
authors.forename: George
authors.initials: G
authors.lastname: Klee
authors.forename: Andrew
authors.initials: A
authors.lastname: Allen
authors.forename: Nam
authors.initials: N
authors.lastname: Kim
authors.forename: Steven
authors.initials: S
authors.lastname: Gutman
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rubin
authors.forename: Andrew
authors.initials: A
authors.lastname: Hruszkewycz
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000032:analysis*; D006801:Humans; D009369:Neoplasms / Q000737:chemistry* / Q000188:drug therapy
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor