DPYD Genotyping Assay Supports Safer Fluoropyrimidine Chemotherapy Dosing

 

Yourgene Health (Manchester, UK) has introduced the IVDR-certified Yourgene Insight DPYD assay, with the commercial launch announced on September 8, 2026 in Paris and Manchester. The rollout follows the assay’s availability as a Research Use Only product in May 2026 and completes its transition to full compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR). The launch expands the company’s clinical genetics portfolio across regulated European markets.

 

The assay uses an ARMS (amplification refractory mutation system) allele‑specific amplification workflow designed for routine laboratory adoption. It includes ready‑to‑use reagents and streamlined data interpretation tools intended to expedite treatment decision‑making. The test was developed in close collaboration with leading clinicians and underwent extensive evaluation to ensure it meets everyday diagnostic needs.

 

The Yourgene Insight DPYD assay enables accurate detection of 19 clinically relevant DPYD variants to support identification of patients at increased risk of severe toxicity from fluoropyrimidine‑based therapy. It is positioned as the first CE‑marked, IVDR‑conforming 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). By aligning content with these recommendations, the assay provides laboratories with a comprehensive solution to support informed chemotherapy dosing and patient management.

 

The company high that IVDR certification broadens market access for the product across highly regulated European settings and reflects continued growth of its clinically focused 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,” said Lyn Rees, Chief Executive Officer of Novacyt.

 

“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,” added Rees.

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