{"id":140388,"title":"Novacyt Launch of IVDR-Certified Yourgene® Insight DPYD Assay","publisher":"Share Talk","author":"sharetalk","published":"2026-09-08T09:55:20+00:00","modified":"2026-09-08T09:55:20+00:00","canonical_url":"https://www.share-talk.com/novacyt-launch-of-ivdr-certified-yourgene-insight-dpyd-assay/","markdown_url":"https://www.share-talk.com/novacyt-launch-of-ivdr-certified-yourgene-insight-dpyd-assay.md","json_url":"https://www.share-talk.com/novacyt-launch-of-ivdr-certified-yourgene-insight-dpyd-assay.json","category":"Health","categories":["Health","Healthcare","Pharmaceutical"],"tags":["Clarence Jaccard-Briat","development","DHSC","diagnostic","diagnostics","families","Graham Mullis","haematology","IT-IS","IT-IS International Ltd","Lab21","Lab21 Products","Lyn Rees","microbiology","molecular","monkeypox","NCYT","NHS England","Novacyt","Novacyt S.A.","Primerdesign","product","Roderic Fuerst","SARS-CoV-21","serology","serology markets","Share Talk","SNPsig","UNICEF","vitro","VoC Framework"],"featured_image":"https://i0.wp.com/www.share-talk.com/wp-content/uploads/2026/09/e5fd6334-98f3-4f58-bc74-277d136fbf72.png?fit=1727%2C911&quality=80&ssl=1","format":"news","language":"en-GB","content":"[Novacyt (AIM: NCYT)](https://www.investegate.co.uk/announcement/rns/novacyt-s-a-cdi---ncyt/launch-of-ivdr-certified-yourgene-dpyd-assay/9759938)has launched its IVDR-certified **Yourgene® Insight DPYD assay** across regulated European markets, expanding the company’s clinical genetics portfolio.\n\nThe commercial launch follows the introduction of the assay as a Research Use Only product in May 2026 and marks completion of its transition to full compliance with the European Union’s **In Vitro Diagnostic Regulation**.\n\nThe assay is designed to detect **19 clinically relevant variants in the DPYD gene**, helping identify patients who may be at increased risk of severe toxicity from fluoropyrimidine-based chemotherapy.\n\nBy identifying these genetic variants before treatment, clinicians can use the information to support safer and more personalised chemotherapy decisions.\n\nNovacyt said the product is the **first IVDR CE-marked DPYD assay to incorporate all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology and the National Comprehensive Cancer Network**.\n\nThe company said this gives laboratories a comprehensive solution aligned with current clinical guidance.\n\nThe assay was developed in collaboration with clinicians and has undergone extensive evaluation for use in routine clinical laboratory settings.\n\nIVDR certification significantly broadens the commercial opportunity for the product, particularly in European markets where regulated diagnostic products are required for clinical use.\n\nThe launch also strengthens Novacyt’s position in pharmacogenomic testing, an area expected to become increasingly important as healthcare systems move towards more personalised treatment strategies.\n\n**Lyn Rees, Chief Executive Officer of Novacyt, commented:**\n\n*“The launch of our IVDR-certified Yourgene® Insight DPYD assay marks an important milestone for Novacyt and demonstrates our ability to turn scientific innovation into clinically relevant diagnostic products.*\n\n*“As precision medicine develops, pharmacogenomic testing is playing an increasingly important role in helping clinicians make safer and more effective treatment decisions. Our assay is the first IVDR-certified DPYD test to incorporate all recommended Tier 1 and Tier 2 variants, providing laboratories with a comprehensive solution aligned with the latest clinical guidance.*\n\n*“The launch further strengthens our clinical genetics portfolio and supports our strategy of building a differentiated, high-value molecular diagnostics business.”*"}