Molecular diagnostics company Yourgene Health has secured TGA regulatory approval in Australia for its Yourgene Insight DPYD assay.
“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,” said Novacyt CEO Lyn Rees. “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.”
The approval enables Southern Cross Diagnostics, also part of the Novacyt Group, to market and supply the in vitro diagnostic (IVD) assay for its approved clinical diagnostic use in Australia. This will help clinical laboratories in Australia to carry out comprehensive pharmacogenetic testing to support safer, personalised chemotherapy treatment for cancer patients.
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 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 Australian approval builds on the 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.
