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Novacyt launches IVDR-certified Yourgene Insight DPYD assay in Europe

Novacyt (ALNOV, NCYT) introduced its IVDR-certified Yourgene Insight DPYD assay, detecting 19 DPYD gene variants linked to fluoropyrimidine chemotherapy toxicity, marking the first CE‑marked test of its kind.

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Helena Vásquez · Business Desk · 13 Sept 2026 · 12:53 · 1 min read
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Novacyt launches IVDR-certified Yourgene Insight DPYD assay in Europe

Novacyt S.A., listed on Euronext Growth (ALNOV) and the AIM market (NCYT), announced the commercial launch of its Yourgene Insight DPYD assay for the European market. The product was unveiled from the company’s Paris and Manchester offices, with corporate headquarters in Le Vésinet, France, and additional sites in the UK, Singapore, the United States and Canada.

The assay received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR), making it the first CE‑marked DPYD test to include all current Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology and the National Comprehensive Cancer Network. It identifies 19 clinically relevant DPYD gene variants that increase a patient’s risk of severe toxicity from fluoropyrimidine‑based chemotherapy.

Originally offered as a Research Use Only product in May 2026, the test was developed in collaboration with clinicians and validated for use in clinical laboratories. Novacyt’s chief executive, Lyn Rees, said the launch demonstrates the company’s ability to translate scientific innovation into clinically relevant products that address urgent healthcare needs.

Novacyt focuses its molecular‑diagnostics portfolio on reproductive health, precision medicine and infectious diseases, expanding its presence in the European in‑vitro diagnostics market with this IVDR‑certified offering.

This article was produced with AI assistance and edited by a Finance Review Daily journalist.
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Written by
Helena Vásquez
Business Desk

Helena covers corporate news for listed and private companies across Europe, from strategy shifts to leadership changes, with an eye for what a story signals about the broader market.

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Novacyt launches IVDR-certified DPYD assay · Finance Review Daily