Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.
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.
Regnier
Fred E
FE
Department of Chemistry, Purdue University, West Lafayette, IN, USA.
Skates
Steven J
SJ
Mesri
Mehdi
M
Rodriguez
Henry
H
Tezak
Zivana
Z
Kondratovich
Marina V
MV
Alterman
Michail A
MA
Levin
Joshua D
JD
Roscoe
Donna
D
Reilly
Eugene
E
Callaghan
James
J
Kelm
Kellie
K
Brown
David
D
Philip
Reena
R
Carr
Steven A
SA
Liebler
Daniel C
DC
Fisher
Susan J
SJ
Tempst
Paul
P
Hiltke
Tara
T
Kessler
Larry G
LG
Kinsinger
Christopher R
CR
Ransohoff
David F
DF
Mansfield
Elizabeth
E
Anderson
N Leigh
NL
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*