Virax Biolabs advances long COVID blood test on positive pilot data
Virax Biolabs Group (NASDAQ:VRAX) announced positive preliminary performance metrics from an early pilot dataset for ViraxImmune™, its proprietary blood-based diagnostic test under development for Long COVID and related post-acute infection syndromes (PAIS).
The London-based biotechnology firm reported that in an ongoing UK clinical assessment involving more than 120 subjects, the test successfully demonstrated a measurable separation between individuals diagnosed with PAIS—including chronic fatigue syndrome (ME/CFS)—and healthy controls.
The pilot performance yielded an 88% specificity rating alongside a 92% positive predictive value (PPV), figures the company intends to use to guide its asset-development strategy.
Virax is preparing to scale its clinical validation program by launching an analytical evaluation of 300 additional, previously collected patient samples.
Processing for this larger validation phase is scheduled to begin in the fourth quarter of 2026, with full diagnostic readouts anticipated in the first quarter of 2027.
The developmental push comes amid a significant gap in objective clinical testing options for post-viral conditions.
Public health figures cited by Virax suggest that up to 21 million adults in the U.S. live with the lingering effects of Long COVID or related syndromes, with an estimated 2.5 million new cases emerging annually.
To commercialize the technology in the face of this substantial target market, Virax intends to pursue an initial U.S. market-entry strategy through a Laboratory Developed Test (LDT) pathway localized to specific clinical laboratories.
The company plans to follow the LDT launch with standard, broader in vitro diagnostic (IVD) approvals over the longer term.
Management notes that ViraxImmune™ remains an investigational device and is not currently cleared or approved for diagnostic utilization by any regulatory body.
