Virax Biolabs Group Limited (NASDAQ: VRAX) (“Virax” or the “Company”), an innovative biotechnology company focused on immune response detection and diagnostics, today announced it has signed a Research Services Agreement (“RSA”) with Emory University’s Center for the Advancement of Diagnostics for a Just Society (“ADJUST Center”) to conduct clinical studies of ViraxImmune™. These studies will focus on immune profiling in individuals with post-viral syndromes, beginning with post-acute sequelae of SARS-CoV-2 (“PASC”), commonly known as long COVID.
Under the agreement, the Emory Laboratory for Innovative Assay Development (“ELIAD”) will conduct patient recruitment, testing, and analysis to generate clinical data. This data is intended to support Virax’s planned regulatory submissions and potential future commercial rollout.
This collaboration aligns with Virax’s preparations for a pre-submission meeting with the U.S. Food and Drug Administration (“FDA”) in early September 2025. The meeting will seek the FDA’s feedback on the proposed intended use and regulatory pathway for ViraxImmune™ in PASC. The outcome will provide formal input on the pivotal U.S. clinical trial design and inform the Company’s regulatory and commercialisation strategy.
“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. This collaboration advances our broader U.S. market entry strategy and represents a significant opportunity to create long-term value for our shareholders as we work to establish Virax as a leader in immune profiling diagnostics.”
Dr. Wilbur A. Lam, MD, PhD, Professor of Pediatrics and Biomedical Engineering at Emory University and Georgia Tech, and Director of the ADJUST Center, commented: “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™ is a proprietary T cell testing technology designed to evaluate a patient’s immune response profile. Unlike conventional antibody testing, it assesses T cell reactivity to provide a more comprehensive picture of immune health in chronic and post-viral conditions.
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