Virax Biolabs Group Limited reported positive early pilot performance data for ViraxImmune?, its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome ("ME/CFS") and related post-acute infection syndromes ("PAIS"). In the pilot dataset, ViraxImmune? demonstrated measurable separation between PAIS patients and healthy controls, achieving 88% specificity and 92% positive predictive value ("PPV").
ViraxImmune? has now been evaluated in more than 120 subjects in the Company's ongoing UK clinical study in Long COVID, ME/CFS and related post-acute infection syndromes. Virax is preparing for its next major development milestone: a larger clinical validation analysis involving previously collected samples from 300 additional participants, with analysis expected to begin in Fourth Quarter 2026 and results expected in First Quarter 2027.
Findings support continued advancement toward Virax's intended U.S. market-entry strategy: an initial PAIS-focused U.S. Laboratory Developed Test ("LDT") route, with broader in vitro diagnostic ("IVD") development planned over time. If validated in larger studies, ViraxImmune? could become one of the first objective immune-profiling approaches developed specifically for Long COVID, ME/CFS and related post-acute infection syndromes.
ViraxImmune? is in development and is not approved for diagnostic use in any jurisdiction. The VRX003 observations are preliminary and are intended to inform ongoing assay development and future clinical validation planning.

















