title: Bioanalytical qualification of clinical biomarker assays in plasma using a novel multi-analyte Simple Plex™platform.
abstract: OBJECTIVE
  Immune-checkpoint inhibitors are presumed to break down the tolerogenic state of immune cells by activating T-lymphocytes that release cytokines and enhance effector cell function for elimination of tumors. Measurement of cytokines is being pursued for better understanding of the mechanism of action of immune-checkpoint inhibitors, as well as to identify potential predictive biomarkers.
  
  
  RESULTS
  In this study, we show bioanalytical qualification of cytokine assays in plasma on a novel multi-analyte immunoassay platform, Simple Plex™. The qualified assays exhibited excellent sensitivity as evidenced by measurement of all samples within the quantifiable range. The accuracy and precision were 80-120% and 10%, respectively.
  
  
  CONCLUSIONS
  The qualified assays will be useful in assessing mechanism of action cancer immunotherapies.
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Vinita
authors.initials: V
authors.lastname: Gupta
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Teresa
authors.initials: T
authors.lastname: Davancaze
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Good
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Navdeep
authors.initials: N
authors.lastname: Kalia
authors.affiliation: New Technologies, Bio-Techne, 614 McKinley Place NE, Minneapolis, MN 55413, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Anderson
authors.affiliation: Oncology Biomarker Development, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Wallin
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Brady
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: An
authors.initials: A
authors.lastname: Song
authors.affiliation: BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA.
authors.forename: Wenfeng
authors.initials: W
authors.lastname: Xu
mesh_terms: D015415:Biomarkers / Q000097:blood*; D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000379:methods*; D018925:Chemokines / Q000097:blood; D016207:Cytokines / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D015203:Reproducibility of Results; D013601:T-Lymphocytes / Q000378:metabolism
chemical_list: D015415:Biomarkers; D018925:Chemokines; D016207:Cytokines
keywords: PD-1; PD-L1; Simple Plex; T-cell activation markers; biomarkers; cytokines; immunoassay; multi-analyte; multiplex