Virax Biolabs Signs Research Agreement with Emory University for Immune Profiling Studies.

Virax Biolabs Group Limited has signed a Research Services Agreement with Emory University's Center for the Advancement of Diagnostics for a Just Society to conduct clinical studies of ViraxImmune™. The studies will focus on immune profiling in individuals with post-viral syndromes, including post-acute sequelae of SARS-CoV-2 (long COVID). The data generated will 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 US Food and Drug Administration.

Virax Biolabs Group Limited (NASDAQ: VRAX) has signed a Research Services Agreement with Emory University's Center for the Advancement of Diagnostics for a Just Society (ADJUST Center) to conduct clinical studies of ViraxImmune™. The studies will focus on immune profiling in individuals with post-viral syndromes, including post-acute sequelae of SARS-CoV-2 (long COVID). The data generated will 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 US Food and Drug Administration (FDA) in early September 2025.

Under the agreement, Emory University's Laboratory for Innovative Assay Development (ELIAD) will handle patient recruitment, testing, and analysis to generate clinical data. The collaboration aims to validate ViraxImmune™, a proprietary T cell testing technology designed to evaluate a patient's immune response profile. Unlike conventional antibody testing, ViraxImmune™ assesses T cell reactivity, providing a more comprehensive picture of immune health in chronic and post-viral conditions.

The partnership is strategically timed to support Virax's regulatory strategy. The FDA pre-submission meeting will discuss the intended use and regulatory pathway for ViraxImmune™ in PASC. The feedback from this meeting will shape the design of Virax's pivotal U.S. clinical trials, a critical step toward potential market authorization.

This collaboration represents a significant milestone in Virax's clinical development strategy. The long COVID diagnostic market presents a substantial opportunity, with millions of affected individuals lacking effective diagnostic tools. If clinical studies generate supportive data and regulatory approval follows, ViraxImmune™ could address this unmet medical need.

Virax's partnership with Emory University's ADJUST Center and the upcoming FDA meeting suggest a methodical approach to market entry in the specialized immune profiling diagnostic sector.

References:
[1] https://www.prnewswire.com/news-releases/virax-biolabs-partners-with-emory-university-on-viraximmune-clinical-studies-readies-for-fda-pre-submission-meeting-in-early-september-302537678.html
[2] https://www.stocktitan.net/news/VRAX/virax-biolabs-partners-with-emory-university-on-virax-immune-tm-hi13o8ehimi1.html
[3] https://www.marketscreener.com/news/virax-biolabs-partners-with-emory-university-on-viraximmunea-clinical-studies-readies-for-fda-pre-ce7c50d9d88cf42c