Launch of IVDR-Certified Yourgene® DPYD Assay
Novacyt S.A. has announced the commercial launch of its IVDR-certified Yourgene® Insight DPYD assay, a significant expansion of its clinical genetics portfolio into regulated European markets. This assay, previously available for research use, now fully complies with the European Union's In Vitro Diagnostic Regulation and is the first CE-marked DPYD assay to incorporate all recommended Tier 1 and Tier 2 variants for identifying patients at risk of severe toxicity from fluoropyrimidine chemotherapy, aligning with guidance from the Association for Molecular Pathology and the National Comprehensive Cancer Network. The IVDR certification is expected to broaden the commercial opportunity for this product, supporting Novacyt's strategy of developing a high-value molecular diagnostics business.
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Paris, France, and Manchester, UK - 8 September 2026 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international molecular diagnostics company with a growing portfolio of integrated technologies and services, announces the commercial launch of the In Vitro Diagnostic Regulation (IVDR)-certified Yourgene® Insight DPYD assay, expanding the Company's clinical genetics portfolio across regulated European markets.
The launch follows the successful introduction of the Yourgene® Insight DPYD assay as a Research Use Only (RUO) product in May 2026 and marks the completion of the assay's regulatory transition to full compliance with the European Union's IVDR.
The Yourgene® Insight DPYD assay enables the accurate detection of 19 clinically relevant variants in the DPYD gene, supporting the identification of patients at increased risk of severe toxicity from fluoropyrimidine-based chemotherapy. The assay provides laboratories and clinicians with an important tool to support informed treatment decisions and improve patient management.
The assay is the first CE marked in accordance with IVDR DPYD assay to incorporate all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology and the National Comprehensive Cancer Network, providing laboratories with a comprehensive solution aligned with the latest clinical guidance. The assay has been developed in close collaboration with leading clinicians and has undergone extensive evaluation to ensure it meets the testing needs of routine clinical laboratories.
The IVDR certification broadens the commercial opportunity for the product, particularly across highly regulated European markets, and represents the continued growth of the Company's clinically relevant molecular diagnostics portfolio.
Lyn Rees, Chief Executive Officer of Novacyt, commented: "The launch of the IVDR-certified Yourgene® Insight DPYD assay is an important milestone for Novacyt and demonstrates our ability to translate scientific innovation into clinically relevant products that address urgent healthcare needs. As precision medicine continues to evolve, pharmacogenomic testing is becoming increasingly important in supporting safer and more effective treatment decisions. By delivering the first IVDR-certified DPYD assay incorporating all recommended Tier 1 and Tier 2 variants, we are providing laboratories with a comprehensive solution that aligns with the latest clinical guidance. This launch further strengthens our clinical genetics portfolio and supports our strategy of building a differentiated, high-value molecular diagnostics business."
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