VCGS achieves ISO 15189 accreditation for whole genome sequencing using Oxford Nanopore technology

Melbourne, Australia, and Oxford, UK, 8 July 2026 – Victorian Clinical Genetics Services (“VCGS”) has received National Association of Testing Authorities (NATA) accreditation to ISO 15189 for a clinical whole genome sequencing workflow incorporating Oxford Nanopore sequencing technology.

Whole human genome sequencing provides a comprehensive view of a person’s DNA, generating richer genetic information that can help clinicians characterise genetic diseases more comprehensively in a single workflow.

The accreditation marks an important step in bringing advanced genomic approaches into regulated clinical practice. The validated workflow supports better resolution in complex genomic regions, variant phasing, and in the future, the detection of complex genomic variation, including structural variants and repeat expansions. This has the potential to improve diagnostic yield, inform clinical decision-making and provide more patients with answers.

ISO 15189 accreditation requires laboratories to demonstrate robust validation, quality management and clinical oversight. The achievement shows how whole genome sequencing using Oxford Nanopore technology can be implemented within a clinically governed diagnostic framework, providing a valuable reference for laboratories evaluating new approaches to genomic testing.

The work also contributes to strengthening Australia’s capability in advanced genomic diagnostics and reflects broader momentum as healthcare systems expand large-scale genomics programmes globally.

Sebastian Lunke, Executive General Manager – Innovation in Genomics at VCGS, commented: “This accreditation reflects the work of our teams to translate emerging genomic technologies into clinically governed practice. It enables us to better resolve complex genomic variation and is an important step towards expanding access to advanced genomic diagnostics for patients and families.”

Gretchen Weightman, VP Commercial and General Manager APAC at Oxford Nanopore Technologies, commented: “This milestone demonstrates how our technology can be implemented within the standards required for clinical laboratories when supported by rigorous validation and governance. It provides a clear reference point for organisations considering how to integrate new sequencing approaches into diagnostic services.”

Oxford Nanopore provided technical support to VCGS during their workflow development and validation within VCGS’s clinically governed laboratory framework, and continues to work with clinical and research partners globally to advance the use of nanopore sequencing in research and clinical settings.