title: Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.
abstract: As a part of ongoing efforts of the NCI-FDA Interagency Oncology Task Force subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the National Cancer Institute have submitted 2 protein-based multiplex assay descriptions to the Office of In Vitro Diagnostic Device Evaluation and Safety, US Food and Drug Administration. The objective was to evaluate the analytical measurement criteria and studies needed to validate protein-based multiplex assays. Each submission described a different protein-based platform: a multiplex immunoaffinity mass spectrometry platform for protein quantification, and an immunological array platform quantifying glycoprotein isoforms. Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays.
authors.affiliation: Department of Chemistry, Purdue University, West Lafayette, IN, USA.
authors.forename: Fred E
authors.initials: FE
authors.lastname: Regnier
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Skates
authors.forename: Mehdi
authors.initials: M
authors.lastname: Mesri
authors.forename: Henry
authors.initials: H
authors.lastname: Rodriguez
authors.forename: Zivana
authors.initials: Z
authors.lastname: Tezak
authors.forename: Marina V
authors.initials: MV
authors.lastname: Kondratovich
authors.forename: Michail A
authors.initials: MA
authors.lastname: Alterman
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Levin
authors.forename: Donna
authors.initials: D
authors.lastname: Roscoe
authors.forename: Eugene
authors.initials: E
authors.lastname: Reilly
authors.forename: James
authors.initials: J
authors.lastname: Callaghan
authors.forename: Kellie
authors.initials: K
authors.lastname: Kelm
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: Reena
authors.initials: R
authors.lastname: Philip
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: David F
authors.initials: DF
authors.lastname: Ransohoff
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mansfield
authors.forename: N Leigh
authors.initials: NL
authors.lastname: Anderson
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods / Q000592:standards*; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards; D013058:Mass Spectrometry / Q000379:methods / Q000592:standards; D040901:Proteomics / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*