July 10, 2025

Introducing the AAV Complement Activation Assay: A New Standard in Safety Assessment for Gene Therapies

In AAV gene therapy, safety isn't optional-it's everything. That's why we're proud to introduce a powerful new tool to your immunogenicity toolkit: the AAV Complement Activation Assay.

This assay is the first of its kind available on the market, giving you a critical edge in detecting and managing immune responses that could compromise patient safety and therapeutic success.

July 10, 2025

Introducing the AAV Complement Activation Assay: A New Standard in Safety Assessment for Gene Therapies

In AAV gene therapy, safety isn't optional-it's everything. That's why we're proud to introduce a powerful new tool to your immunogenicity toolkit: the AAV Complement Activation Assay.

This assay is the first of its kind available on the market, giving you a critical edge in detecting and managing immune responses that could compromise patient safety and therapeutic success.

Why Complement Activation Matter 

While neutralizing and total antibodies have long been the focus of immunogenicity testing, complement activation is an emerging risk factor-and one that's gaining attention from regulators and clinicians alike.

Unchecked complement activation can lead to serious adverse events, including inflammation and tissue damage. Our assay helps you:

  • Detect predisposition to AAV-mediated complement activation
  • Reduce the risk of immune-related complications
  • Strengthen your safety profile for regulatory review

 

What Makes Our Assay Different

Our Complement Activation Assay is currently offered exclusively through our CRO services, including:

  • Assay development & customization, and subsequent sample analysis
  • Scientific consultation and data interpretation
  • Integration with our full immunogenicity panel (NAb + TAb)

Off-the-shelf kits are in development and will be available soon, but you can start benefiting from this assay today through our expert team.

Combine It with the Full Trifecta

Our AAV-associated Complement Activation Assay is the newest addition to our AAV immunogenicity platform, which also includes:

Together, these assays provide a comprehensive overview of immune response, helping you make smarter decisions at every stage of development.

Ready to Add Complement Testing to Your Program?

If you're developing AAV-based therapies, this assay could be the missing piece in your safety strategy. Let's talk about how it fits into your workflow, whether as a standalone test or part of a custom-built solution.

Contact us today to learn more or request a consultation. 

Contact us