Assays that measure neutralizing antibodies (NAb) have become an essential part of the development process for many gene therapeutics. When these NAb assays are used to determine eligibility for treatment, there are heightened regulatory concerns.

Watch Travis Harrison’s (VP, Bioassay Solutions at Precision for Medicine) on-demand presentation from Gene Therapy Immunogenicity Summit “Development of a Neutralizing Antibody Assay as a Diagnostic,” as he explains a development strategy for use of a NAb assay as a diagnostic assay for a pivotal clinical trial and subsequent use as a companion diagnostic.

See a recording of his presentation here!