1. Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration
- Author
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Mehdi Mesri, James Callaghan, Larry Kessler, Donna Roscoe, Steven J. Skates, Daniel C. Liebler, Henry Rodriguez, David F. Ransohoff, Tara Hiltke, Michail A. Alterman, Reena Philip, David G. Brown, Eugene Reilly, Paul Tempst, Steven A. Carr, Elizabeth Mansfield, Susan J. Fisher, Fred E. Regnier, Marina Kondratovich, Joshua D. Levin, Živana Težak, N. Leigh Anderson, Kellie Kelm, and Christopher R. Kinsinger
- Subjects
Immunoassay ,Proteomics ,Task force ,Diagnostic Tests, Routine ,United States Food and Drug Administration ,Biochemistry (medical) ,Clinical Biochemistry ,Quantitative proteomics ,Biology ,Molecular diagnostics ,Bioinformatics ,In vitro diagnostic ,Mass Spectrometry ,United States ,Food and drug administration ,DEVICE EVALUATION ,Humans ,Multiplex - 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.
- Published
- 2009