Virax Biolabs Reports Positive Early Data for Long COVID Test
Virax Biolabs Group reported positive early pilot performance data for ViraxImmune its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, and related post-acute infection syndromes, or PAIS. In the pilot dataset, ViraxImmune demonstrated measurable separation between PAIS patients and healthy controls, achieving 88% specificity and 92% positive predictive value, or PPV - early performance metrics that Virax believes support continued development and advancement into larger clinical validation. Based on estimates derived from CDC, the RECOVER Initiative and other peer-reviewed and public-health sources, Virax estimates that up to 21 million adults in the U.S. may currently be living with Long COVID and related PAIS conditions, with approximately 2.5 million new cases estimated each year. Virax believes this represents a significant potential U.S. testing opportunity in an area where many patients are often assessed through symptoms and exclusion, rather than objective immune biomarkers of the type ViraxImmune is being developed to assess. Highlights include: In the pilot dataset, ViraxImmune demonstrated measurable separation between PAIS patients and healthy controls and achieved 88% specificity and 92% 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 Q4 2026 and results expected in Q1 2027. 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.
