title: The US Food and Drug Administration perspective on cancer biomarker development.
abstract: Despite the intense interest in biomarker development for cancer management, few biomarker assays for diagnostic uses have been submitted to the US Food and Drug Administration (FDA). What challenges must researchers overcome to bring cancer-detection technologies to the market and, therefore, into clinical use?
authors.affiliation: Office of in vitro Diagnostic Devices, Center for Devices and Radiological Health, Food and Drug Administration, NFZ-440, 2098 Gaither Road, Rockville, Maryland 20857, USA. steve.gutman@fda.hhs.gov
authors.forename: Steven
authors.initials: S
authors.lastname: Gutman
authors.forename: Larry G
authors.initials: LG
authors.lastname: Kessler
mesh_terms: D001681:Biological Assay / Q000379:methods / Q000592:standards; D014408:Biomarkers, Tumor; D006801:Humans; D040541:Marketing; D009369:Neoplasms / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic