Bioanalytical qualification of clinical biomarker assays in plasma using a novel multi-analyte Simple Plex™ platform

Author:

Gupta Vinita1,Davancaze Teresa1,Good Jeremy1,Kalia Navdeep1,Anderson Michael2,Wallin Jeffrey J3,Brady Ann1,Song An1,Xu Wenfeng1

Affiliation:

1. BioAnalytical Sciences, Genentech Inc, South San Francisco, CA 94080, USA

2. New Technologies, Bio-Techne, 614 McKinley Place NE, Minneapolis, MN 55413, USA

3. Oncology Biomarker Development, Genentech Inc, South San Francisco, CA 94080, USA

Abstract

Aim: 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. Conclusion: The qualified assays will be useful in assessing mechanism of action cancer immunotherapies.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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