Title |
Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration
|
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Published in |
Clinical Chemistry, February 2010
|
DOI | 10.1373/clinchem.2009.140087 |
Pubmed ID | |
Authors |
Fred E Regnier, Steven J Skates, Mehdi Mesri, Henry Rodriguez, Živana Težak, Marina V Kondratovich, Michail A Alterman, Joshua D Levin, Donna Roscoe, Eugene Reilly, James Callaghan, Kellie Kelm, David Brown, Reena Philip, Steven A Carr, Daniel C Liebler, Susan J Fisher, Paul Tempst, Tara Hiltke, Larry G Kessler, Christopher R Kinsinger, David F Ransohoff, Elizabeth Mansfield, N Leigh Anderson |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Switzerland | 1 | 1% |
France | 1 | 1% |
Ireland | 1 | 1% |
United Kingdom | 1 | 1% |
United States | 1 | 1% |
Unknown | 69 | 93% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 30 | 41% |
Professor > Associate Professor | 10 | 14% |
Other | 7 | 9% |
Professor | 7 | 9% |
Student > Master | 5 | 7% |
Other | 10 | 14% |
Unknown | 5 | 7% |
Readers by discipline | Count | As % |
---|---|---|
Agricultural and Biological Sciences | 33 | 45% |
Biochemistry, Genetics and Molecular Biology | 8 | 11% |
Chemistry | 7 | 9% |
Medicine and Dentistry | 7 | 9% |
Computer Science | 4 | 5% |
Other | 8 | 11% |
Unknown | 7 | 9% |