Virax Biolabs Group Limited (NASDAQ: VRAX) announced that its fully owned subsidiary, Virax Biolabs (UK) Limited, has secured ISO 13485:2016 and ISO 9001:2015 certifications for its quality management systems. The certifications were granted by LRQA on 18 February 2026 and are valid through 17 February 2029.
Key highlights:
Virax states that these enhanced quality standards reinforce its strategy around post-acute infection syndromes (PAIS), improving preparedness for regulated in vitro diagnostic (IVD) development and supporting ongoing U.S. clinical validation efforts.
The company is also exploring potential U.S.-based laboratory testing services, which could include a laboratory-developed test (LDT) pathway.
Under the approved scope, ISO 13485:2016 applies to the design and development of immunological assay components and kits—such as antibody- and peptide-based reagents—for IVD use. ISO 9001:2015, meanwhile, covers the manufacturing, design, and development of Virax’s research-use-only products and related services.
Both ISO 13485 and ISO 9001 are globally recognized standards for quality management. They provide structured frameworks for areas such as design control, risk management, traceability, supplier qualification, and consistent manufacturing processes. While ISO 13485 is specific to medical devices and diagnostics, ISO 9001 is a broader standard used across industries. Virax believes these certifications enhance the controls and documentation required to advance regulated diagnostic programs and support clinical validation.
The company views these achievements as a strong operational base for its quality-driven development initiatives, including its diagnostic technologies targeting PAIS conditions like post-acute sequelae of SARS-CoV-2 (PASC), commonly known as Long COVID. They also support Virax’s broader objective of building a T cell immune-profiling platform with clinical and regulatory reach across both Europe and the United States.
At the same time, Virax continues to move forward with its U.S. clinical validation work, which it believes benefits from the strengthened quality framework. As previously announced, the company has signed a Research Services Agreement (RSA) with Emory University’s ADJUST Center to carry out clinical studies of ViraxImmune™, focusing on immune profiling in individuals with PASC. Under this collaboration, Emory will perform laboratory testing and data analysis to generate clinical insights that may guide Virax’s regulatory strategy and potential commercialization.
Virax emphasizes that improving its quality systems supports disciplined development of critical assay components and associated documentation, which in turn can aid validation processes and future scale-up plans, subject to regulatory requirements.
“Securing ISO 13485 and ISO 9001 certifications marks an important milestone for Virax,” said Chairman and CEO James Foster. “It underscores the progress our team has made in establishing strong quality systems to support the regulated development of our immunological assays. This is particularly significant as we advance our PAIS strategy, strengthen our foundation for IVD development, expand clinical evidence across the UK and U.S., and assess potential U.S. laboratory testing pathways, including an LDT option.”