Novacyt launches its Dpyd Yourgene Insight test certified IVDR in Europe
The molecular diagnostic company announced the commercialization of its Yourgene Insight DPYD test under IVDR certification, a development axis that extends its growth in clinical genetics on regulated European markets.
This market launch follows an initial introduction of the test for research purposes in May 2026.
Novacyt announced on September 8, 2026 the commercial launch of the Yourgene Insight DPYD test, certified in compliance with the European regulation on in vitro diagnostic medical devices (IVDR).
The test detects 19 variants of the DPYD gene, in order to identify patients at increased risk of severe toxicity related to fluoropyrimidine-based chemotherapies. According to the Company, it is the first DPYD test with CE certification following IVDR regulations to integrate all level 1 and level 2 variants recommended by the Association for Molecular Pathology and the National Comprehensive Cancer Network.
This launch follows the introduction of the test as a research-use-only (RUO) product in May 2026 and marks the completion of its regulatory transition towards IVDR compliance.
Expansion of the clinical genetics range
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IVDR certification expands the product's commercial prospects, particularly on regulated European markets, and is part of the development of the Company's molecular diagnostics portfolio.
Lyn Rees, Chief Executive Officer of Novacyt, stated that this launch « further strengthens our portfolio in the field of clinical genetics » and « supports our strategy to develop a differentiated molecular diagnostic business with high added value ».
Novacyt, whose headquarters is located in Vésinet, operates commercially in more than 65 countries and is listed on Euronext Growth in Paris as well as on the AIM market in London.
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SectorDispositifs médicaux et optique›Dispositifs médicaux
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Context
Period
Period: S1 2026
Key reported figures
Revenue: 11,6 MGBP
Quarterly revenue: 11,6 MGBP
Revenue growth: 18 %
EBITDA: -3,9 MGBP
Net income: -5,8 MGBP
Guidance from the release
Nous demeurons pleinement confiants dans les perspectives à long terme du Groupe et sommes convaincus que les mesures prises au cours des deux dernières années ont permis de forger une entreprise plus solide, mieux ciblée et engagée sur une trajectoire claire vers une croissance organique pérenne.
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