Virax Biolabs Achieves ISO Certifications, Laying Foundation for Regulated IVD Development and U.S. Clinical Validation
LONDON, March 31, 2026 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ:VRAX) ("Virax" or the "Company") today announced that Virax Biolabs (UK) Limited, its wholly owned subsidiary, has achieved ISO 13485:2016 and ISO 9001:2015 certification for its quality management system. The certifications were issued by LRQA, with an issue date of 18 February 2026 and an expiry date of 17 February 2029.
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 U.S. clinical validation work, which the Company believes is supported by a strengthened quality framework. As previously disclosed, Virax has entered into a Research Services Agreement ("RSA") with Emory University's ADJUST Center to conduct clinical studies of ViraxImmune™ focused on immune profiling in individuals with PASC (commonly referred to as "Long COVID"). Under the agreement, Emory will conduct laboratory testing and analysis to generate clinical data intended to inform Virax's regulatory planning and potential future commercial rollout.
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 UK and U.S. clinical programmes, while also evaluating potential U.S. laboratory-based testing pathways, which may include an LDT route."
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
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