Pre-screening for anti-AAV antibodies in patients is a critical step in AAV-based gene therapy development. This session will focus on a key discussion point across the industry regarding the assay format (total antibody or neutralizing antibody assay) that is most relevant and provides the best scientific information to make patient treatment decisions. Other practical considerations such as which assay formats allow us to provide results in a timely fashion and are amenable to companion diagnostic development will also be discussed.
Learning Objectives:
Identify the assay formats currently being employed across AAV gene therapies to support pre-existing immunogenicity testing for clinical trials
Understand the utility of these assays (NAb, TAb, IgG) during pre-enrollment and risks and benefits of the approaches
Understand the requirements for developing a lab derived test for prescreen vs a diagnostic test