LONDON , May 26, 2026 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX ) ("Virax" or the "Company") today 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") — 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 United States 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: In the pilot dataset, ViraxImmune™ demonstrated measurable separation between PAIS patients and healthy controls and achieved 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 Q4 2026 and results expected in Q1 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. Virax believes this approach could support a differentiated diagnostic strategy in an area of significant unmet need, with potential applications in patient stratification, clinical decision-making , longitudinal monitoring and therapeutic development. "These early pilot data mark an important step in the development of ViraxImmune™ as a potential objective immune-profiling test for Long COVID, ME/CFS and related post-acute infection syndromes," said James Foster, Chairman and Chief Executive Officer of Virax Biolabs. "The observed separation between patients and healthy controls, together with encouraging early performance metrics, supports our confidence that ViraxImmune™ has the potential to address a major unmet diagnostic need as we advance toward our planned U.S. LDT-first route to market." "Patients with Long COVID, ME/CFS and related post-acute infection syndromes often face lengthy diagnostic journeys and limited objective testing options," said Dr. Sean Knight, MD, PhD, Principal Investigator at the Lydia Becker Institute of Immunology and Inflammation, University of Manchester, and Consultant Respiratory Physician at Northern Care Alliance NHS Foundation Trust. "Objective immune profiling may help improve how these patients are assessed, stratified and monitored over time. These early pilot findings are encouraging and support further clinical validation of ViraxImmune™." Virax will host an investor webcast on May 26, 2026, at 4:15 p.m. ET to review the early ViraxImmune™ dataset, discuss the clinical and commercial implications of the findings, and outline the Company's planned path toward larger clinical validation, assay finalization and U.S. market entry. Interested parties may register for the webcast at this link . A replay will be made available following the event. 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. About Virax Biolabs Group Limited Virax Biolabs Group Limited is a biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. The Company is developing T cell-based test technologies intended to support an immunology profiling platform. T cell testing may have applications in post-acute infection syndromes, including Long COVID, and other chronic conditions linked to immune dysregulation. For more information, please visit www.viraxbiolabs.com Caution Concerning Forward-Looking Statements This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements
