Virax Biolabs Group Limited (NASDAQ: VRAX) has announced a strategic partnership with Emory University's Center for the Advancement of Diagnostics for a Just Society (ADJUST Center) to advance clinical studies of its ViraxImmune™ diagnostic technology. The collaboration focuses on immune profiling in individuals with post-viral syndromes, beginning with post-acute sequelae of SARS-CoV-2 (PASC), commonly known as long COVID.
Clinical Study Framework
Under the Research Services Agreement, the Emory Laboratory for Innovative Assay Development (ELIAD) will conduct comprehensive patient recruitment, testing, and analysis to generate clinical data supporting Virax's planned regulatory submissions and potential commercial rollout. This partnership leverages Emory University's recognized expertise in immunology and clinical research to validate ViraxImmune™ in real-world patient populations.
The collaboration aligns with Virax's preparations for a pre-submission meeting with the U.S. Food and Drug Administration scheduled for early September 2025. The meeting will seek FDA feedback on the proposed intended use and regulatory pathway for ViraxImmune™ in PASC diagnosis, with outcomes expected to provide formal input on pivotal U.S. clinical trial design and inform the company's regulatory and commercialization strategy.
Addressing Diagnostic Gaps in Long COVID
"Partnering with Emory University, one of the foremost institutions in immunology and clinical research, is an important step toward validating ViraxImmune™ in real-world patient populations," said James Foster, Chief Executive Officer of Virax Biolabs. "With millions suffering from long COVID and other post-viral conditions without effective diagnostic options, we believe ViraxImmune™ is uniquely positioned to fill this gap."
Dr. Wilbur A. Lam, MD, PhD, Professor of Pediatrics and Biomedical Engineering at Emory University and Georgia Tech, and Director of the ADJUST Center, emphasized the clinical need: "PASC and other post-viral syndromes remain poorly understood and underdiagnosed. Immune profiling technologies could provide critical insights into patient immune function, enabling more precise diagnosis and potentially guiding treatment strategies."
ViraxImmune™ Technology Platform
ViraxImmune™ represents a proprietary T cell testing technology designed to evaluate a patient's immune response profile. Unlike conventional antibody testing, the platform assesses T cell reactivity to provide a more comprehensive picture of immune health in chronic and post-viral conditions. This T cell-based approach can be particularly effective in the diagnosis and therapeutics of post-viral syndromes such as long COVID and other chronic conditions linked to immune dysregulation.
Strategic Market Positioning
The collaboration advances Virax's broader U.S. market entry strategy and represents what the company describes as a significant opportunity to create long-term value for shareholders as it works to establish itself as a leader in immune profiling diagnostics. The partnership with Emory University, a leading research institution recognized internationally for its contributions to medical innovation and scientific discovery, particularly in infectious diseases and immunology, provides critical validation for the technology platform.
Emory's School of Medicine and affiliated healthcare network bring particular strengths in infectious diseases, immunology, and clinical trial execution to the collaboration, positioning the partnership to generate robust clinical evidence for regulatory review and potential commercial deployment.
