Therapeutic antibodies are increasingly used to treat different types of cancer, including breast cancer, the second most commonly diagnosed cancer worldwide. Many of these therapeutic antibodies work, at least in part, by activating antibody-dependent cell-mediated cytotoxicity (ADCC). In ADCC, an effector cell actively lyses a target cell that is bound by a specific antibody.

Trastuzumab is an anti-HER2 therapeutic antibody commonly used for treating HER2 positive breast cancer patients. Svar has developed a sensitive and specific functional cell-based iLite® ADCC HER2 assay.

In this study, the authors have analyzed this assay for some of the most critical parameters included in clinical bioassay characterization: serum tolerance, cut-point determination, neutralizing antibody (NAb) assay sensitivity using different antibodies and drug tolerance evaluation at high NAb level.

From their preliminary results, they conclude that the iLite® ADCC HER2 assay can be used for clinical applications to analyze patient samples and determine the presence of NAbs in clinical samples.

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