Gene Therapy Immunogenicity Summit (August 3-5)
Precision’s Travis Harrison (Vice President, Bioassay Solutions) presents at the Gene Therapy Immunogenicity Summit. Don’t miss this presentation on October 4th at 12.30pm ET
Development of a Neutralizing Antibody Assay as a Diagnostic
• Assays that measure neutralizing antibodies (NAb) have become an essential
part of the development process for many gene therapeutics
• When NAb assays are used to determine eligibility for treatment, there are
heightened regulatory concerns
• Development strategy for use of a NAb assay as a diagnostic assay for a pivotal
clinical trial and subsequent use as a companion diagnostic