Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.
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.
Rodriguez
Henry
H
National Cancer Institute-Food and Drug Administration Interagency Oncology Task Force on Molecular Diagnostics, National Institutes of Health, Bethesda, MD 20892, USA. rodriguezh@mail.nih.gov
Tezak
Zivana
Z
Mesri
Mehdi
M
Carr
Steven A
SA
Liebler
Daniel C
DC
Fisher
Susan J
SJ
Tempst
Paul
P
Hiltke
Tara
T
Kessler
Larry G
LG
Kinsinger
Christopher R
CR
Philip
Reena
R
Ransohoff
David F
DF
Skates
Steven J
SJ
Regnier
Fred E
FE
Anderson
N Leigh
NL
Mansfield
Elizabeth
E
D014408:Biomarkers, Tumor / Q000097:blood*; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000097:blood / Q000175:diagnosis*; D040901:Proteomics / Q000379:methods* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D054928:Validation Studies as Topic
D014408:Biomarkers, Tumor