Yourgene Health, part of the Novacyt Group, has announced the commercial launch of its In Vitro Diagnostic Regulation (IVDR)-certified Yourgene® Insight DPYD assay, extending the company’s clinical genetics portfolio into regulated European markets. The launch was announced in Paris, France, and Manchester, UK, on 8 September 2026, and follows the assay’s earlier introduction as a Research Use Only (RUO) product in May 2026.

Detecting variants linked to fluoropyrimidine toxicity

The Yourgene Insight DPYD assay enables the detection of 19 clinically relevant variants in the dihydropyrimidine de-hydrogenase (DPYD) gene. This supports the identification of patients at increased risk of severe toxicity from fluoro­pyrimidine-based chemotherapy, giving laboratories and clinicians a tool to support informed treatment decisions and improve patient management.

Lyn Rees, Chief Executive Officer of Novacyt

Aligned with AMP and NCCN guidance

The company describes the assay as the first CE-marked, IVDR-compliant 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). The test uses an ARMS (amplification refractory mutation system) allele-specific amplification workflow, with ready-to-use reagents and data interpretation tools intended to expedite personalised treatment decisions. The assay was developed in collaboration with clinicians and has undergone extensive evaluation for use in routine clinical laboratories.

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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