8 Best Practices For Immunogenicity Assay And Companion Diagnostic Development In AAV Gene Therapy

The FDA's focus on immunogenicity testing stems from the need to assess pre-existing immunity in patients, which can significantly impact the efficacy and safety of gene therapies. Pre-existing immunity refers to the presence of antibodies in a patient's system that may neutralize the therapeutic gene vector, thereby reducing its effectiveness or causing adverse reactions. Given this regulatory requirement, gene therapy companies are increasingly collaborating with diagnostic developers on AAV gene therapy assay development and CDx co-development.

These assays are designed to detect and measure the levels of pre-existing antibodies against the gene therapy vectors. By identifying patients with high levels of pre-existing immunity, these tests help ensure that gene therapies are administered to those who are most likely to benefit from them, while minimizing potential risks. Read more to understand why the partnership between gene therapy companies and diagnostic developers is crucial for advancing the field of gene therapy to not only facilitate compliance with FDA regulations but also enhance the overall safety and efficacy of gene therapies.