Virax Biolabs Secures ISO Quality Milestones to Advance Long COVID and PAIS Diagnostic Strategy

Virax Biolabs Group Limited (NASDAQ: VRAX) announced that its UK subsidiary has obtained ISO 13485:2016 and ISO 9001:2015 certification for its quality management system, issued by LRQA and valid through February 2029. ISO 13485 covers the design and development of immunological assay components and kits for in vitro diagnostic (IVD) use, while ISO 9001 covers manufacturing, design and development of Virax’s research‑use‑only products and services.

 Foundation for U.S. clinical validation and potential LDTs

Virax believes these certifications lay the operational groundwork for regulated IVD development and ongoing U.S. clinical validation work tied to its post‑acute infection syndromes (PAIS) strategy, including Long COVID (PASC). The company is also evaluating potential U.S. laboratory‑based testing services, which may include pursuing a laboratory‑developed test (LDT) pathway to market.

 Supporting ViraxImmune and PAIS pipeline

The strengthened quality framework is intended to support disciplined development and control of key assay components for ViraxImmune, the company’s T‑cell–based immune‑profiling platform for PAIS, including Long COVID. Virax views ISO‑aligned design control, risk management, and documentation as critical to scaling its T‑cell diagnostics platform across the UK and U.S. under a more traditional regulated IVD model over time.

 Emory partnership drives Long COVID evidence base

In parallel, Virax continues U.S. clinical validation through a Research Services Agreement with Emory University’s ADJUST Center to study ViraxImmune in people with PASC (Long COVID). Emory is generating lab data intended to inform Virax’s regulatory planning and potential future commercial rollout, which the company believes will be supported and de‑risked by its upgraded quality systems.

Investor angle for VRAX

For VRAX shareholders, ISO 13485 and ISO 9001 do not guarantee regulatory approval, but they are key gating steps for any diagnostics company seeking to operate under regulated IVD and LDT frameworks. If Virax can pair these certifications with positive Emory data and clear regulatory paths, its T‑cell immune‑profiling platform could emerge as a differentiated Long COVID and PAIS diagnostic play in a market where standardized tools remain limited.