Virax Biolabs Achieves ISO Certifications, Laying Foundation for Regulated IVD Development and U.S. Clinical Validation
Rhea-AI Summary
Virax Biolabs (NASDAQ: VRAX) achieved ISO 13485:2016 and ISO 9001:2015 certification for its quality management system, issued by LRQA on 18 February 2026 and expiring 17 February 2029.
The company says the certifications support regulated IVD development readiness, U.S. clinical validation of ViraxImmune™, and evaluation of potential U.S. lab-based testing pathways including an LDT route.
Positive
- ISO 13485:2016 & ISO 9001:2015 certified (issue 18 Feb 2026, expiry 17 Feb 2029)
- Signed Research Services Agreement with Emory University for clinical validation of ViraxImmune
- Scope covers design/development of immunological assay components and RUO product manufacturing
Negative
- Certifications are scope-limited to assay components, kits and RUO products
- U.S. clinical validation with Emory is ongoing; no clinical readouts reported yet
News Market Reaction – VRAX
On the day this news was published, VRAX gained 35.32%, reflecting a significant positive market reaction. Argus tracked a peak move of +83.5% during that session. Argus tracked a trough of -2.4% from its starting point during tracking. Our momentum scanner triggered 42 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $426K to the company's valuation, bringing the market cap to $1.63M at that time. Trading volume was exceptionally heavy at 186.0x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Highlights:
- Virax believes the strengthened quality framework supports its post-acute infection syndromes ("PAIS") strategy by strengthening readiness for regulated in vitro diagnostic ("IVD") development and supporting
U.S. clinical validation activities. - Virax is also evaluating potential
U.S. laboratory-based testing service offerings, which may include a laboratory-developed test ("LDT") pathway.
Within the scope of approval, ISO 13485:2016 covers the design and development of immunological assay components and kits, including antibody- and peptide-based reagents, for IVD applications. Within the scope of approval, ISO 9001:2015 covers the provision of manufacturing, design and development of Virax's research-use-only products and services.
ISO 13485 and ISO 9001 are internationally recognised quality management standards that establish a framework for design control, risk management, traceability, supplier qualification and manufacturing consistency. In simple terms, ISO 13485 is a widely used quality standard for medical devices and diagnostics, while ISO 9001 is a broader quality management standard used across many industries. Virax believes these certifications strengthen the controls and documentation needed to advance regulated diagnostics programmes and support clinical validation work.
Virax believes these certifications provide an important operational foundation for the Company's quality-managed development activities, including its in-development diagnostic technology for post-acute infection syndromes ("PAIS"), such as post-acute sequelae of SARS-CoV-2 ("PASC") (commonly referred to as "Long COVID"), and support the Company's broader strategy to build a T cell immune-profiling platform with a transatlantic clinical and regulatory footprint.
In parallel, Virax continues to advance its
Virax believes strengthening its quality systems is relevant to disciplined development and control of key assay components and supporting documentation processes, which can support validation activities and scale-up planning, subject to applicable regulatory requirements.
"Achieving ISO 13485 and ISO 9001 certification is a meaningful milestone for Virax," said James Foster, Chairman and Chief Executive Officer of Virax Biolabs. "It reflects the work our team has done to implement robust quality systems that support the regulated development of our immunological assays. This matters as we continue to execute our PAIS strategy, including strengthening the foundation for regulated IVD development and expanding our evidence base through
About Virax Biolabs Group Limited
Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. Virax Biolabs Group Limited is developing T cell-based test technologies with the intention of providing an immunology profiling platform. T cell testing can be particularly effective in the diagnosis and therapeutics of 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 change the direction of the Company; our ability to keep pace with new technology and changing market needs; 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, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.
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SOURCE Virax BioLabs Group Limited