Virax Biolabs Group Limited announced it has signed a Research Services Agreement ("RSA") with Emory University'sCenter 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. 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.
