Novacyt S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international molecular diagnostics company headquartered in France with UK operations in Manchester, has received regulatory approval from Australia's Therapeutic Goods Administration (TGA) for its Yourgene® Insight DPYD assay. The approval enables Southern Cross Diagnostics Pty Ltd, the Group's Australian subsidiary acquired in March 2026, to market the assay for clinical diagnostic use — moving it beyond its previous research-use-only status. The Australian addressable market for DPYD testing is estimated by the company at approximately 16,000 to 66,000 tests per year, representing an annual reimbursed testing value to laboratories of approximately A$3.0 million to A$12.0 million based on the current Australian Medicare reimbursement rate of approximately A$182 per test.

Key Points

  • Novacyt S.A. (AIM: NCYT / EURONEXT GROWTH: ALNOV)
  • TGA has approved the Yourgene® Insight DPYD assay for clinical diagnostic supply in Australia via Southern Cross Diagnostics
  • Estimated Australian addressable market of 16,000–66,000 tests per year; reimbursed at approximately A$182 per test under Medicare
  • Investors may watch for clinical laboratory uptake in Australia and further international regulatory submissions following IVDR certification in September 2026

TGA Approval Unlocks Clinical Diagnostic Market for Novacyt's DPYD Assay in Australia

The Therapeutic Goods Administration approval means the Yourgene® Insight DPYD assay is now included on the Australian Register of Therapeutic Goods (ARTG) as a Class 3 pharmacogenetic in vitro diagnostic device, with Southern Cross Diagnostics acting as the Australian sponsor. The assay is manufactured by Yourgene Health, part of the Novacyt Group, and was previously available in Australia on a research-use-only basis following its launch in May 2026. TGA approval now permits Australian clinical laboratories to deploy the assay in routine diagnostic practice, a materially different and broader commercial pathway than research use alone.

Yourgene® Insight DPYD Assay Detects 19 DPYD Variants to Identify Chemotherapy Toxicity Risk

The assay detects 19 clinically relevant variants in the DPYD gene, supporting the identification of patients at increased risk of severe or potentially fatal toxicity when receiving 5-fluorouracil (5-FU) chemotherapy. The announcement states the product is the first CE-marked DPYD assay certified under the European Union's In Vitro Diagnostic Regulation (IVDR) to incorporate all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology and the National Comprehensive Cancer Network. IVDR certification was achieved in September 2026, with TGA approval now extending the assay's regulatory credentials into the Asia-Pacific region.

Southern Cross Diagnostics Acquisition Provides Novacyt with Australian Distribution for Group Products

Novacyt acquired Southern Cross Diagnostics in March 2026, establishing a commercial presence in Australia and broader access to the Asia-Pacific life sciences and diagnostics markets. The TGA approval demonstrates how the Group intends to leverage that acquisition by channelling products developed elsewhere in the business through its Australian distribution infrastructure. The company operates across more than 65 countries and is organised into three segments: Clinical, Instrumentation, and Research Use Only, with the DPYD assay sitting within its Precision Medicine offering under the Clinical division.

Estimated A$3.0 Million to A$12.0 Million Annual Market Signals Commercial Upside for Novacyt's Pharmacogenomics Strategy

Novacyt's own estimate places the total annual reimbursed testing value to Australian laboratories at approximately A$3.0 million to A$12.0 million, based on current Medicare rates. The wide range reflects uncertainty in test volume uptake, and actual revenues realised by Novacyt will depend on the Group's market share rather than total market size. Investors may be watching for further detail on commercialisation timelines, laboratory contracting progress, and whether international regulatory submissions — building on IVDR and TGA credentials — are pursued in additional markets as part of the Group's stated strategy to grow its clinical genetics business.