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Clin Chem DOI:10.1373/clinchem.2009.136416

Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.

Publication TypeJournal Article
Year of Publication2010
AuthorsRodriguez, H, Tezak, Z, Mesri, M, Carr, SA, Liebler, DC, Fisher, SJ, Tempst, P, Hiltke, T, Kessler, LG, Kinsinger, CR, Philip, R, Ransohoff, DF, Skates, SJ, Regnier, FE, N Anderson, L, Mansfield, E
Corporate AuthorsWorkshop Participants
JournalClin Chem
Date Published2010 Feb
KeywordsBiomarkers, Tumor, Humans, Mass Spectrometry, National Cancer Institute (U.S.), Neoplasms, Proteomics, United States, United States Food and Drug Administration, Validation Studies as Topic

Clinical proteomics has the potential to enable the early detection of cancer through the development of multiplex assays that can inform clinical decisions. However, there has been some uncertainty among translational researchers and developers as to the specific analytical measurement criteria needed to validate protein-based multiplex assays. To begin to address the causes of this uncertainty, a day-long workshop titled "Interagency Oncology Task Force Molecular Diagnostics Workshop" was held in which members of the proteomics and regulatory communities discussed many of the analytical evaluation issues that the field should address in development of protein-based multiplex assays for clinical use. This meeting report explores the issues raised at the workshop and details the recommendations that came out of the day's discussions, such as a workshop summary discussing the analytical evaluation issues that specific proteomic technologies should address when seeking US Food and Drug Administration approval.


Alternate JournalClin. Chem.
PubMed ID20007859