Virax Biolabs (NASDAQ: VRAX) reports positive ViraxImmune Long COVID data
Rhea-AI Filing Summary
Virax Biolabs Group Limited reported early pilot performance data for ViraxImmune™, a blood-based test in development for Long COVID, ME/CFS and related post-acute infection syndromes. In the pilot dataset, the test showed measurable separation between PAIS patients and healthy controls, with 88% specificity and 92% positive predictive value.
ViraxImmune™ has been evaluated in more than 120 subjects in an ongoing UK clinical study. Virax plans a larger clinical validation using samples from 300 additional participants, with analysis expected to begin in Q4 2026 and results expected in Q1 2027, supporting a planned U.S. market-entry via a PAIS-focused Laboratory Developed Test followed by broader in vitro diagnostic development. Virax estimates up to 21 million U.S. adults may be living with Long COVID and related PAIS conditions, with about 2.5 million new cases each year.
Positive
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Negative
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Insights
Early ViraxImmune™ pilot data look encouraging but remain preliminary.
Virax Biolabs released pilot performance data for its ViraxImmune™ immune-profiling test in Long COVID and related syndromes, reporting 88% specificity and 92% positive predictive value. The assay has been run in more than 120 subjects in an ongoing UK study.
The company outlines a next step of analyzing samples from 300 additional participants, with work starting in Q4 2026 and results in Q1 2027. These numbers come from an internal pilot dataset and are described as preliminary, with ViraxImmune™ not yet approved for diagnostic use.
If future validation supports the pilot findings, Virax plans a U.S. Laboratory Developed Test route first, followed by broader in vitro diagnostic development. Actual commercial impact will depend on outcomes of the larger validation, regulatory interactions and how the sizable estimated PAIS population is addressed.
Key Figures
Key Terms
post-acute infection syndromes medical
positive predictive value medical
Laboratory Developed Test regulatory
in vitro diagnostic regulatory
forward-looking statements regulatory
immune profiling medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2026
Commission File Number: 001-41440
Virax Biolabs Group Limited
(Registrant’s Name)
BioCity Glasgow
Bo'Ness Road Newhouse
Lanarkshire, ML1 SUH
United Kingdom
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
When used in this Form 6-K, unless otherwise indicated, the terms “the Company,” “Virax,” “we,” “us” and “our” refer to Virax Biolabs Group Limited. and its subsidiaries.
Information Contained in this Form 6-K Report
On May 26, 2026, Virax Biolabs Group Limited issued a press release today reporting 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:
A copy of the press release dated May 26, 2026 is included as Exhibit 99.1 to this report.
Exhibits
Exhibit No |
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Description |
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99.1 |
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Press release dated May 26, 2026 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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VIRAX BIOLABS GROUP LIMITED |
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Date: |
May 26, 2026 |
By: |
/s/ James Foster |
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James Foster, Chief Executive Officer |
Exhibit 99.1
Virax Biolabs Reports Positive Early Clinical Data for ViraxImmune™ in Long COVID and Related Post-Acute Infection Syndromes
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:
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 orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms.
In evaluating these forward-looking statements, you should consider various factors, including: our ability to keep pace with new technology and changing market needs; potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of preliminary, interim or top-line data to accurately reflect the complete results of a trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA and other regulators’ agreement on the regulatory path for ViraxImmune™ or other potential products; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us.
These forward-looking statements are based on information currently available to Virax and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Virax’s Annual Report on Form 20-F for the year ended March 31, 2025. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions.
Company Contact:
Virax Biolabs Group Limited
Phone: +44 020 7788 7414
Email: info@viraxbiolabs.com
Investor Contact:
Dave Gentry, CEO
RedChip Companies, Inc.
Phone: 1-407-644-4256
Email: VRAX@redchip.com