Virax Biolabs Group Limited announced that it has successfully completed patient recruitment for its United Kingdom-based, multi-centre clinical study evaluating the performance of the ViraxImmune?? assay in detecting T cell dysfunction in Post-Acute Infection Syndromes ("PAIS"), including Long COVID, post-treatment Lyme disease ("PTLD"), and Myalgic Encephalomyelitis /Chronic Fatigue Syndrome ("ME/CFS"). 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.
It was randomised in a 3:1 ratio between symptomatic and non-symptomatic participants, with 40 patients recruited for each of the three symptomatic cohorts representing Long COVID, PTLD, and ME/CFS. In parallel, Virax announced that it received final minutes from its productive pre-submission meeting with the U.S. Food and Drug Administration ("FDA") on September 10, 2025, to discuss the proposed regulatory pathway for its ViraxImmune?? T cell assay.
The meeting provided constructive feedback on the Company's continued development of the assay for use in patients with post-acute COVID-19 infection. Virax is incorporating the Agency's recommendations into its ongoing clinical and analytical development programs to support progress toward a future submission in the United States. The Company anticipates commencing its U.S.-based clinical study in 2026 in partnership with Emory University.
Initial read-outs from this longitudinal study are expected in second quarter 2026.
