Novacyt S A Cdi — Australian approval for Yourgene® DPYD Assay

(LSE:NCYT) Novacyt S.A. announced that it received TGA approval on 11 November 2026 to supply the Yourgene® Insight DPYD in vitro diagnostic for clinical use in Australia. This approval converts the Yourgene® Insight DPYD assay from Research Use Only status following IVDR certification in September 2026. The Yourgene® Insight DPYD assay is designed to detect 19 DPYD variants. The company estimates the Australian addressable market for this assay is between 16,000 and 66,000 tests per year. The current Medicare reimbursement rate for the test is approximately A$182 per test. Based on these figures, the annual reimbursed market value to laboratories is estimated at approximately A$3.0 million to A$12.0 million. This approval extends the near-term commercial revenue potential for Novacyt in Australia. The transition from Research Use Only to clinical use is enabled by the IVDR certification achieved in September 2026. The TGA approval date is specifically 11 November 2026. The company highlights the significance of the Australian market opportunity for the Yourgene® Insight DPYD assay. The product's ability to detect 19 DPYD variants is a key feature. The company is positioning the assay for clinical use following regulatory milestones. The announcement quantifies both the test volume opportunity and the associated reimbursed market value. The company is targeting laboratories as the primary customers for the assay in Australia. The approval is expected to drive commercial revenue in the near term.