title: Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.
abstract: Clinical proteomics has the potential to enable the early detection of cancer through the development of multiplex assays that can inform clinical decisions. However, there has been some uncertainty among translational researchers and developers as to the specific analytical measurement criteria needed to validate protein-based multiplex assays. To begin to address the causes of this uncertainty, a day-long workshop titled "Interagency Oncology Task Force Molecular Diagnostics Workshop" was held in which members of the proteomics and regulatory communities discussed many of the analytical evaluation issues that the field should address in development of protein-based multiplex assays for clinical use. This meeting report explores the issues raised at the workshop and details the recommendations that came out of the day's discussions, such as a workshop summary discussing the analytical evaluation issues that specific proteomic technologies should address when seeking US Food and Drug Administration approval.
authors.affiliation: National Cancer Institute-Food and Drug Administration Interagency Oncology Task Force on Molecular Diagnostics, National Institutes of Health, Bethesda, MD 20892, USA. rodriguezh@mail.nih.gov
authors.forename: Henry
authors.initials: H
authors.lastname: Rodriguez
authors.forename: Zivana
authors.initials: Z
authors.lastname: Tezak
authors.forename: Mehdi
authors.initials: M
authors.lastname: Mesri
authors.forename: Steven A
authors.initials: SA
authors.lastname: Carr
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Liebler
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Fisher
authors.forename: Paul
authors.initials: P
authors.lastname: Tempst
authors.forename: Tara
authors.initials: T
authors.lastname: Hiltke
authors.forename: Larry G
authors.initials: LG
authors.lastname: Kessler
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Kinsinger
authors.forename: Reena
authors.initials: R
authors.lastname: Philip
authors.forename: David F
authors.initials: DF
authors.lastname: Ransohoff
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Skates
authors.forename: Fred E
authors.initials: FE
authors.lastname: Regnier
authors.forename: N Leigh
authors.initials: NL
authors.lastname: Anderson
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mansfield
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000097:blood / Q000175:diagnosis*; D040901:Proteomics / Q000379:methods* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic
chemical_list: D014408:Biomarkers, Tumor