LONDON, United Kingdom, May 26, 2026
Virax Biolabs Group Limited has announced encouraging early clinical data for ViraxImmune™, its investigational blood-based immune profiling test designed to support the diagnosis and assessment of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and related post-acute infection syndromes (PAIS). The biotechnology company reported that the pilot dataset demonstrated measurable immune-profile separation between affected patients and healthy controls, achieving 88% specificity and a 92% positive predictive value (PPV), findings that support continued development and larger clinical validation studies.
Virax stated that ViraxImmune™ has now been evaluated in more than 120 participants as part of its ongoing UK clinical study focused on immune dysfunction associated with Long COVID and related chronic post-viral conditions. The company plans to advance into a larger validation analysis involving samples from an additional 300 participants, with testing expected to begin in the fourth quarter of 2026 and results anticipated during the first quarter of 2027. If validated successfully, ViraxImmune™ could emerge as one of the first objective immune-profiling diagnostic approaches specifically developed for Long COVID and related immune dysregulation disorders.
ViraxImmune™ Targets Growing Long COVID Crisis
Long COVID and post-acute infection syndromes have become major global healthcare concerns following the COVID-19 pandemic, with millions of patients continuing to experience persistent symptoms months or even years after initial infection. Symptoms frequently include severe fatigue, cognitive dysfunction, breathing difficulties, muscle pain, and neurological complications that significantly affect quality of life and long-term health outcomes.
According to estimates referenced by Virax from the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) RECOVER Initiative, up to 21 million adults in the United States may currently be living with Long COVID and related post-acute infection syndromes, with approximately 2.5 million new cases emerging annually.
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Despite the scale of the problem, healthcare providers currently lack widely accepted objective laboratory tests capable of diagnosing or monitoring many of these conditions. Most patients are assessed primarily through symptom evaluation and exclusion of alternative diagnoses. Virax believes ViraxImmune™ could help address this major unmet need by introducing a blood-based immune profiling platform designed to identify measurable immune abnormalities associated with chronic post-viral syndromes.
Immune Profiling Technology Advances Diagnostic Innovation
ViraxImmune™ is being developed as a T cell-based immune profiling technology, reflecting growing scientific interest in the role of immune dysregulation and chronic inflammation in Long COVID and ME/CFS. The company believes the platform could potentially support patient stratification, clinical monitoring, therapeutic development, and more precise disease management strategies in the future.
James Foster, Chairman and Chief Executive Officer of Virax Biolabs, described the pilot findings as an important milestone toward developing an objective diagnostic tool for patients often facing lengthy and uncertain diagnostic journeys. Researchers involved in the study also emphasized the importance of objective immune biomarkers in improving clinical understanding and patient assessment for post-acute infection syndromes.
Dr. Sean Knight, Principal Investigator at the Lydia Becker Institute of Immunology and Inflammation at the University of Manchester, stated that objective immune profiling may significantly improve how patients with Long COVID and related syndromes are evaluated and monitored over time.
The company intends to initially pursue a U.S. Laboratory Developed Test (LDT) commercialization strategy before expanding into broader in vitro diagnostic (IVD) development pathways in future stages.
Biotechnology Sector Focuses on Post-Viral Disorders
The announcement reflects increasing investment within the biotechnology industry aimed at addressing chronic post-viral illnesses and immune dysregulation disorders. Long COVID research has accelerated rapidly over recent years as healthcare systems, researchers, and biotechnology companies seek diagnostic and therapeutic solutions for patients with persistent symptoms.
Industry analysts believe immune profiling technologies may become increasingly important in precision medicine and chronic disease management, particularly in conditions where conventional biomarkers and diagnostic tools remain limited. If future studies confirm the early findings, ViraxImmune™ could help establish a new category of diagnostic testing focused on immune-based characterization of chronic post-infectious disorders.
Source: Virax Biolabs press release
