Yourgene Health has secured Australian regulatory approval for its DPYD assay, enabling clinical laboratories to test patients for chemotherapy toxicity risk.

Yourgene Health has secured Australian regulatory approval for its Insight DPYD assay, allowing the pharmacogenetic test to be supplied for clinical diagnostic use in Australia.

The Therapeutic Goods Administration (TGA) approval enables Southern Cross Diagnostics, also part of the Novacyt Group, to market and distribute the in vitro diagnostic (IVD) assay to clinical laboratories.

The assay detects 19 clinically relevant variants in the DPYD gene, which can help identify patients at increased risk of severe or potentially fatal toxicity from 5-fluorouracil (5-FU), a chemotherapy drug used to treat several types of cancer.

DPYD testing is important because patients with certain genetic variants can have reduced activity of the dihydropyrimidine dehydrogenase (DPD) enzyme, which is responsible for breaking down 5-FU. Reduced enzyme activity can result in higher drug exposure and an increased risk of serious adverse reactions.

Australian approval expands clinical testing access

The assay is included on the Australian Register of Therapeutic Goods (ARTG) as a Class 3 pharmacogenetic IVD device, with Southern Cross Diagnostics acting as the Australian sponsor.

The approval follows the launch of the Yourgene Insight DPYD assay as a research-use-only product in May 2026 and its subsequent certification under the European Union’s In Vitro Diagnostic Regulation (IVDR) in September.

The Australian authorisation extends the assay’s availability into another regulated clinical diagnostics market, allowing laboratories to use it for pharmacogenetic testing rather than research purposes alone.

Lyn Rees, chief executive officer of Novacyt, said: “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.”

Assay targets 19 DPYD variants

The Yourgene Insight DPYD assay uses an amplification refractory mutation system (ARMS) allele-specific amplification workflow to detect 19 variants associated with reduced DPD activity.

Yourgene says the assay incorporates all current Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology (AMP) and the National Comprehensive Cancer Network (NCCN).

Its workflow includes ready-to-use reagents and data interpretation tools intended to support routine laboratory testing.

The company says the assay has been developed in collaboration with clinicians and is designed to help laboratories provide pharmacogenetic information to support chemotherapy treatment decisions.

Rees added: “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.”

The approval also supports Novacyt’s strategy to expand its clinical genetics business and increase access to pharmacogenetic testing.