Virax Biolabs Completes Patient Recruitment for Clinical Study of ViraxImmune[TM] Assay in Detection of T Cell Dysfunction in Post-Acute Infection Syndromes

Strategic Insights -

Virax Biolabs Group Limited, a biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases, has successfully completed patient recruitment for its clinical study evaluating the performance of the ViraxImmune[TM] assay in detecting T cell dysfunction in Post-Acute Infection Syndromes (PAIS). The study, conducted in collaboration with the UK's National Health Service (NHS), has achieved full enrolment ahead of schedule, reaching its target of 160 participants. The trial is designed to evaluate T cell dysfunction and immune dysregulation underlying the major symptoms observed in PAIS.

Key Takeaways:

  • The clinical study has successfully recruited 160 participants, including 40 patients for each of the three symptomatic cohorts representing Long COVID, post-treatment Lyme disease (PTLD), and Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS).
  • The study is designed to evaluate the performance of the ViraxImmune[TM] assay in detecting T cell dysfunction as an aid in diagnosing PAIS in patients experiencing persistent and debilitating fatigue.
  • The results from this analysis are intended to support regulatory submissions in the United Kingdom, including filings with the Medicines and Healthcare products Regulatory Agency (MHRA), and may also inform subsequent U.S. submissions.
  • The company has received constructive feedback from the U.S. Food and Drug Administration (FDA) on its proposed regulatory pathway for the ViraxImmune[TM] T cell assay and is incorporating the Agency's recommendations into its ongoing clinical and analytical development programs.
  • Virax Biolabs is partnering with Emory University to commence its U.S.-based clinical study in 2026, which will focus on the development of ViraxImmune[TM] as a diagnostic tool for post-acute COVID-19 infection.
  • The company's Chief Executive Officer, James Foster, stated that the completion of full UK clinical recruitment ahead of schedule and the receipt of constructive FDA feedback represent significant milestones for the ViraxImmune[TM] program.

Statistics:

  • 160 participants were recruited for the clinical study, exceeding the target recruitment number.
  • 40 patients were recruited for each of the three symptomatic cohorts representing Long COVID, post-treatment Lyme disease (PTLD), and Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS).
  • The study is intended to support regulatory submissions in the United Kingdom and inform subsequent U.S. submissions.
  • The company anticipates commencing its U.S.-based clinical study in 2026 in partnership with Emory University.

Sources:

  • Virax BioLabs Group Limited, "Virax Biolabs Completes Patient Recruitment for Clinical Study of ViraxImmune[TM] Assay in Detection of T Cell Dysfunction in Post-Acute Infection Syndromes" (November 3, 2025)
  • PRNewswire, "Virax Biolabs Completes Patient Recruitment for Clinical Study of ViraxImmune[TM] Assay in Detection of T Cell Dysfunction in Post-Acute Infection Syndromes" (November 3, 2025)