Yourgene Health launches IVDR-certified Yourgene Insight DPYD assay in Europe

Yourgene Health, part of the Novacyt Group, has commercially launched its In Vitro Diagnostic Regulation (IVDR)-certified Yourgene^® Insight DPYD assay across regulated European markets following the assay’s introduction as a Research Use Only (RUO) product in May 2026.

DPYD testing supports personalized chemotherapy decisions

The Yourgene Insight DPYD assay is designed to accurately detect 19 clinically relevant DPYD gene variants. Identifying these variants can help determine which patients face an increased risk of severe toxicity from fluoropyrimidine-based chemotherapy, providing an important tool for patient management and personalised treatment decisions.

The commercial launch completes the assay’s transition from an RUO product to full compliance with the European Union’s IVDR.

Assay includes recommended Tier 1 and Tier 2 DPYD variants

The assay is the first CE-marked DPYD test under IVDR 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). This coverage gives laboratories a comprehensive testing solution aligned with the latest clinical guidance.

Its ARMS (amplification refractory mutation system) allele-specific amplification workflow includes ready-to-use reagents and straightforward data interpretation tools designed to expedite personalised treatment decisions. Developed in close collaboration with leading clinicians, the assay has undergone extensive evaluation to ensure it meets the needs of routine clinical laboratories.

IVDR certification expands access in regulated European markets

IVDR certification broadens the commercial opportunity for the Yourgene Insight DPYD assay, particularly in highly regulated European markets. The launch also supports the continued growth of Yourgene Health’s clinically relevant molecular diagnostics and clinical genetics 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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