Analytical validation of protein-based multiplex assays: A workshop report by the NCI-FDA Interagency Oncology Task Force on Molecular Diagnostics Journal Article


Authors: Rodriguez, H.; Težak, Ž; Mesri, M.; Carr, S. A.; Liebler, D. C.; Fisher, S. J.; Tempst, P.; Hiltke, T.; Kessler, L. G.; Kinsinger, C. R.; Philip, R.; Ransohoff, D. F.; Skates, S. J.; Regnier, F. E.; Anderson, N. L.; Mansfield, E.; On behalf of the Workshop Participants
Contributors: Fleisher, M.; Lilja, H.
Article Title: Analytical validation of protein-based multiplex assays: A workshop report by the NCI-FDA Interagency Oncology Task Force on Molecular Diagnostics
Abstract: 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. © 2009 American Association for Clinical Chemistry.
Keywords: review; united states; united states food and drug administration; cancer diagnosis; neoplasms; mass spectrometry; diagnostic procedure; clinical assessment; tumor markers, biological; food and drug administration; proteomics; tumor marker; assay; risk assessment; microarray analysis; national cancer institute (u.s.); validation studies as topic; humans
Journal Title: Clinical Chemistry
Volume: 56
Issue: 2
ISSN: 0009-9147
Publisher: American Association for Clinical Chemistry  
Date Published: 2010-02-01
Start Page: 237
End Page: 243
Language: English
DOI: 10.1373/clinchem.2009.136416
PUBMED: 20007859
PROVIDER: scopus
DOI/URL:
Notes: Review -- Export Date: 22 February 2016 -- Source: Scopus
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MSK Authors
  1. Hans Gosta Lilja
    286 Lilja
  2. Paul J Tempst
    312 Tempst
  3. Martin Fleisher
    245 Fleisher