Yourgene Health (part of the Novacyt Group), an international molecular diagnostics company with a broad portfolio of integrated technologies and services, announces Australian regulatory approval for its Yourgene® Insight DPYD assay. The approval enables Southern Cross Diagnostics Pty Ltd, also part of the Novacyt Group, to market and supply the in vitro diagnostic (IVD) assay for its approved clinical diagnostic use in Australia.
Extending its commercial opportunity beyond research use only, will enable clinical laboratories in Australia to carry out comprehensive pharmacogenetic testing to support safer, personalized chemotherapy treatment for cancer patients.
The Therapeutic Goods Administration (TGA) has approved the supply of the Yourgene Insight DPYD assay in Australia. The assay, manufactured by Yourgene Health, is covered by an Australian Register of Therapeutic Goods (ARTG) inclusion for Class 3 pharmacogenetic IVD devices, held by Southern Cross Diagnostics as the Australian sponsor. It is also certified under the European Union's In Vitro Diagnostic Regulation (IVDR).
The Yourgene Insight DPYD assay detects 19 clinically relevant variants in the DPYD gene, supporting the identification of patients at increased risk of severe or potentially fatal toxicity during 5-fluorouracil (5-FU) treatment. It provides laboratories and clinicians with information to support informed treatment decisions and improve patient management.
The Australian approval builds on the successful launch of the Yourgene Insight DPYD assay as a Research Use Only (RUO) product in May 2026, followed by its certification under the IVDR in September 2026. TGA approval represents a further step in the product's international regulatory expansion, enabling access to another highly regulated market.
The Yourgene Insight DPYD assay is the first CE-marked DPYD assay certified under IVDR to incorporate all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology (AMP) and the National Comprehensive Cancer Network (NCCN). The ARMS (amplification refractory mutation system) allele-specific amplification workflow includes ready-to-use reagents and simple data interpretation tools to expedite personalized treatment decisions. Developed in close collaboration with leading clinicians and subject to extensive evaluation, the assay provides a comprehensive testing solution designed to meet the requirements of routine clinical laboratories.
Australian approval expands the commercial opportunity for our Yourgene Insight DPYD assay into routine clinical testing. Through Southern Cross Diagnostics, we can now offer Australian laboratories a registered diagnostic assay to support the identification of patients at increased risk of severe chemotherapy toxicity."
Lyn Rees, Chief Executive Officer, Novacyt
"Following IVDR certification in September, this approval advances our international expansion and demonstrates how our Australian distribution business can bring products from across the Group to clinical customers. We can bring our established pharmacogenomics testing solution to a wider international customer base and supports our strategy to grow our clinical genetics business and broaden access to pharmacogenomic testing."
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