Virax Biolabs Reports Positive Early Data for Long COVID Test ViraxImmune
Virax Biolabs Group Limited reported positive early pilot performance data for ViraxImmune , its blood-based test in development for Long COVID, ME/CFS, and related post-acute infection syndromes (PAIS). The test demonstrated 88% specificity and 92% positive predictive value (PPV) in the pilot dataset, showing measurable separation between PAIS patients and healthy controls. ViraxImmune has been evaluated in over 120 subjects in an ongoing UK clinical study, and the company is preparing for a larger clinical validation analysis involving 300 additional participants, with results expected in Q1 2027. The findings support Virax's strategy for U.S. market entry via an initial PAIS-focused Laboratory Developed Test (LDT) route.
Key Highlights
- ViraxImmune demonstrated 88% specificity and 92% positive predictive value (PPV) in pilot data.
- Test evaluated in over 120 subjects in ongoing UK clinical study for Long COVID and ME/CFS.
- Larger clinical validation analysis with 300 additional participants expected to begin in Q4 2026.
- Results from the larger validation analysis are expected in Q1 2027.
- Company plans initial U.S. market entry via Laboratory Developed Test (LDT) route.
- Virax estimates up to 21 million U.S. adults may have Long COVID and related PAIS conditions.
- An estimated 2.5 million new cases of Long COVID and related PAIS occur annually in the U.S.
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