ELISA assay employing epitope-specific monoclonal antibodies to quantify circulating HER2 with potential application in monitoring cancer patients undergoing therapy with trastuzumab.

ABSTRACT: Circulating HER2 extracellular domain (HER2 ECD) levels were proposed as a surrogate for HER2 tissue expression to monitor breast cancer patients for early relapse or responses to standard or HER2-targeted therapies, such as the monoclonal antibody (mAb) trastuzumab. Currently, available commercial ELISA assays for HER2 ECD rely on antibodies recognizing undisclosed or unknown epitopes. In this work, two ELISA assays employing MGR2 and MGR3 epitope-specific mAbs for HER2 ECD were developed and validated, showing good assay precision and linearity of the dose-response signal within the dynamic range of 0.19-12.50 ng mL^-1 and detection limits of 0.76 and 0.75 ng mL^-1 for the MGR2 and MGR3 assays, respectively. The developed assay showed a good agreement with two widely

SUBMITTER: Agnolon V 

PROVIDER: S-EPMC7033231 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature