Yourgene Health (part of the Novacyt Group), an international molecular diagnostics company with a broad portfolio of integrated technologies and services, announces the commercial launch of its 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 dihydropyrimidine dehydrogenase (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 test 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), providing laboratories with a comprehensive solution aligned with the latest clinical guidance. The ARMS (amplification refractory mutation system) allele-specific amplification workflow includes ready-to-use reagents and simple data interpretation tools to expedite personalized treatment decisions. It 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.
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."
Lyn Rees, Chief Executive Officer, Novacyt
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