Paris and Manchester, Sept. 8, 2026 — Yourgene Health, part of the Novacyt Group, announced Tuesday the commercial launch of its IVDR-certified Yourgene® Insight DPYD assay, a pharmacogenetic test designed to help clinicians identify cancer patients at heightened risk of severe toxicity from commonly used chemotherapy drugs.
The assay, which received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR), detects 19 clinically relevant variants in the DPYD gene, enabling more informed treatment decisions for patients prescribed fluoropyrimidine-based regimens such as 5-fluorouracil and capecitabine.
A First Under New European Rules
According to Novacyt, the Yourgene Insight DPYD assay is the first CE-marked test under IVDR to incorporate all current Tier 1 and Tier 2 genetic variants recommended by the Association for Molecular Pathology (AMP) and the National Comprehensive Cancer Network (NCCN).
The test builds on the company’s May 2026 launch of the assay as a Research Use Only (RUO) product, completing its transition to full regulatory compliance for routine clinical laboratories across Europe.
Why DPYD Testing Matters
Deficiency in the dihydropyrimidine dehydrogenase (DPYD) enzyme affects an estimated 3% to 5% of patients and can lead to severe, sometimes life-threatening toxicity when standard doses of fluoropyrimidine chemotherapy are administered. Prospective testing and dose adjustments have been shown to mitigate these risks.
The assay uses an ARMS (amplification refractory mutation system) workflow with ready-to-use reagents and simplified data interpretation tools, developed in collaboration with clinicians to meet the practical needs of hospital and reference laboratories.
Executive Perspective
“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,” said Lyn Rees, Chief Executive Officer of Novacyt.
Rees added that as precision medicine evolves, pharmacogenomic testing is becoming increasingly important in supporting safer and more effective treatment decisions. The company said the certification broadens commercial opportunities across highly regulated European markets and strengthens its clinical genetics portfolio.
Availability
The Yourgene Insight DPYD assay is now available for order across IVDR-regulated European markets. Further information is available at: https://yourgenehealth.com/products/yourgene-insight-dpyd/.
About Yourgene Health and Novacyt
Yourgene Health is an international molecular diagnostics company and part of the Novacyt Group, offering an integrated portfolio of technologies and services in clinical genetics and diagnostics. Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) focuses on building a differentiated, high-value molecular diagnostics business with clinically relevant products.
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