Journal
CLINICAL CHEMISTRY
Volume 56, Issue 2, Pages 165-171Publisher
AMER ASSOC CLINICAL CHEMISTRY
DOI: 10.1373/clinchem.2009.140087
Keywords
-
Categories
Funding
- National Cancer Institute, Clinical Proteomic Technology Assessment for Cancer
- National Cancer Institute-NIH
- Agilent Technologies
Ask authors/readers for more resources
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. (C) 2009 American Association for Clinical Chemistry
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available