Virax Biolabs Group Limited VRAX announced on Tuesday that it had 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.
ViraxImmune is a proprietary T cell testing technology 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.
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. The data is intended to support Virax's planned regulatory submissions and potential future commercial rollout.
The 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 ViraxImmune's proposed intended use and regulatory pathway 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…"
In March, Virax Biolabs started patient enrollment for its multi-center clinical study in the United Kingdom to assess the ViraxImmune FluoroSpot T cell assay's performance in detecting T cell dysfunction in post-acute infection syndrome patients.
Up to 200 participants will be enrolled in the study, and initial data from this longitudinal assessment are expected in the second quarter of 2026.
Price Action: VRAX stock closed at $0.774 on Monday.
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