Virax Biolabs Achieves ISO 13485:2016 and ISO 9001:2015 for U.S. IVD Development
Virax Biolabs’ UK subsidiary obtained ISO 13485:2016 and ISO 9001:2015 certifications covering immunological assay design and manufacturing, valid Feb 18, 2026–Feb 17, 2029. These quality standards underpin its PAIS strategy by bolstering regulated IVD development, U.S. clinical validation with Emory University, and potential laboratory-developed test offerings.
1. ISO Certification Overview
Virax Biolabs (UK) achieved ISO 13485:2016 and ISO 9001:2015 certification from LRQA, covering design and development of immunological assay components and manufacturing of research-use-only products. Certifications were issued on February 18, 2026 and expire on February 17, 2029.
2. Support for PAIS Strategy
The strengthened quality framework enhances design control, risk management and traceability for post-acute infection syndrome (PAIS) diagnostics. It provides operational consistency for developing T cell-based assays targeting conditions like Long COVID as part of Virax’s immune-profiling platform.
3. U.S. Clinical Validation and Emory Partnership
Leveraging the new certifications, Virax is advancing clinical validation under a Research Services Agreement with Emory University’s ADJUST Center. Emory will conduct laboratory testing and analysis of ViraxImmune™ to generate data informing regulatory planning and potential commercial rollout in the U.S.
4. Potential U.S. Laboratory Testing Pathways
In parallel, Virax is evaluating U.S. laboratory-based testing service offerings, including a laboratory-developed test (LDT) pathway. This evaluation aims to establish scalable diagnostic services subject to applicable regulatory requirements.