Virax Biolabs Teams With Emory to Validate Long COVID T-Cell Test

Virax Biolabs Group Limited said it has signed a research services agreement with Emory University’s ADJUST Center to run clinical studies of ViraxImmune, the company’s proprietary T-cell diagnostic aimed at identifying post-acute sequelae of SARS-CoV-2, more commonly known as long COVID. Emory’s Laboratory for Innovative Assay Development will recruit patients, carry out testing and analyse data to support Virax’s regulatory filings and eventual commercial rollout in the United States. The collaboration is designed to generate evidence ahead of a pre-submission meeting Virax has scheduled with the US Food and Drug Administration in early September. Feedback from the FDA is expected to guide the pivotal US trial design and the regulatory pathway for ViraxImmune. Virax, listed on Nasdaq under the ticker VRAX, said it views the partnership as a key step toward breaking into the US market for immune-profiling diagnostics, an area where demand is growing as millions of people continue to experience long-term effects of COVID-19.