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    'Fit-for-purpose' validation of SearchLight multiplex ELISAs of angiogenesis for clinical trial use.

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    Authors
    Backen, Alison C
    Cummings, Jeffrey
    Mitchell, Claire L
    Jayson, Gordon C
    Ward, Timothy H
    Dive, Caroline
    Affiliation
    CR-UK Translational Angiogenesis Group, Paterson Institute for Cancer Research, University of Manchester, Wilmslow Road, Manchester, M20 4BX, UK.
    Issue Date
    2009-03-15
    
    Metadata
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    Abstract
    Validated assays of circulating biomarkers of angiogenesis to predict and determine the efficacy of vascular-targeted anticancer drugs would facilitate successful drug development. Multiple biomarker candidates exist and a multiplex approach was sought to minimise the requisite patient blood volume and to aid selection of those biomarkers with greatest potential clinical utility. Validation of the SearchLight multiplex ELISA platform comprising two multiplex assays of nine potential angiogenesis biomarkers was conducted (plex 1; VEGF R1 and R2, IL-8, KGF, PlGF; plex 2; PDGFbb, HGF, FGFb and VEGF). The study focused on instrument qualification, analyte specificity within the multiplex format, assay precision and reproducibility. No evidence was found within the multiplex that signals output from one analyte impinged on another or that antibody cross-reactivity occurred. Spike recovery for 5 between-experiment repeats was within +/-15% of input values for 7 of the 9 multiplexed analytes, with a coefficient of variation (CV) of <20% for 6 of the 9 analytes. Plasma samples from 8 ovarian cancer patients (who were not receiving therapy) were assessed using the two multiplexes on this platform to explore the likely baseline variability in this disease context. This study suggests that the platform and the multiplex approach will be useful to evaluate pharmacodynamic responses to vascular targeted therapy in early clinical trials.
    Citation
    'Fit-for-purpose' validation of SearchLight multiplex ELISAs of angiogenesis for clinical trial use. 2009, 342 (1-2):106-14 J. Immunol. Methods
    Journal
    Journal of Immunological Methods
    URI
    http://hdl.handle.net/10541/52813
    DOI
    10.1016/j.jim.2009.01.003
    PubMed ID
    19174166
    Type
    Article
    Language
    en
    ISSN
    0022-1759
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.jim.2009.01.003
    Scopus Count
    Collections
    All Paterson Institute for Cancer Research
    Clinical and Experimental Pharmacology Group
    Medical Oncology

    entitlement

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