Strategic Diagnostics in Action:

The challenge

A global pharmaceutical company focused on maximizing adoption of its gene therapy needed to establish seamless AAV antibody testing. Unlike other gene therapies administered in immune-privileged areas, this therapy involved systemic delivery using an AAV vector. The client had partnered with a diagnostic company and intended to launch with a centralized lab model. Testing for the disease was decentralized and implementing a centralized model risked delays in delivering timely, accurate results - potentially limiting global access to the gene therapy. Diaceutics was contracted to design a global strategy that would enable the client to understand and overcome barriers that could delay patient identification.

• Testing Barriers: Because AAV antibody testing was not part of routine diagnostics, establishing the infrastructure and awareness needed to support its adoption posed a significant barrier to timely patient identification and therapy access.
• Testing Sample Logistics: The centralized lab model created logistical complexities, requiring blood samples to be transported across borders to a single site. This posed risks to timely testing and patient access potentially compounded by affordability challenges because the required test was not yet reimbursed within markets.  
• Global Strategy: Designing a global strategy required tailoring approaches for diverse healthcare systems, balancing a centralized testing model with regional logistics and regulatory nuances to support consistent access across markets.