Launch of IVDR-Certified Yourgene® DPYD Assay

Novacyt S.A.

08 September 2026

 

8 September 2026

Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Launch of IVDR-Certified Yourgene® Insight DPYD Assay

Paris, France, and Manchester, UK - 8 September 2026 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international molecular diagnostics company with a growing portfolio of integrated technologies and services, announces the commercial launch of the In Vitro Diagnostic Regulation (IVDR)-certified Yourgene® Insight DPYD assay, expanding the Company's clinical genetics portfolio across regulated European markets.

The launch follows the successful introduction of the Yourgene® Insight DPYD assay as a Research Use Only (RUO) product in May 2026 and marks the completion of the assay's regulatory transition to full compliance with the European Union's IVDR.

The Yourgene® Insight DPYD assay enables the accurate detection of 19 clinically relevant variants in the DPYD gene, supporting the identification of patients at increased risk of severe toxicity from fluoropyrimidine-based chemotherapy. The assay provides laboratories and clinicians with an important tool to support informed treatment decisions and improve patient management.

The assay is the first CE marked in accordance with IVDR 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, providing laboratories with a comprehensive solution aligned with the latest clinical guidance. The assay has been developed in close collaboration with leading clinicians and has undergone extensive evaluation to ensure it meets the testing needs of routine clinical laboratories.

The IVDR certification broadens the commercial opportunity for the product, particularly across highly regulated European markets, and represents the continued growth of the Company's clinically relevant molecular diagnostics portfolio.

Lyn Rees, Chief Executive Officer of Novacyt, commented: "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. 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."

Contacts

Novacyt SA			https://novacyt.com/investors
Lyn Rees, Chief Executive Officer			Via Walbrook PR
Steve Gibson, Chief Financial Officer
SP Angel Corporate Finance LLP (Nominated Adviser and Broker)				[phone]
Matthew Johnson / Charlie Bouverat (Corporate Finance) Vadim Alexandre / Rob Rees (Corporate Broking)
Singer Capital Markets (Joint Broker)				[phone]
Russell Cook / Graham Hertrich / James Fischer
Allegra Finance (French Listing Sponsor) Rémi Durgetto / Yannick Petit		[phone] [e-mail] / [e-mail]
Walbrook PR (Financial PR & IR) Paul McManus / Alice Woodings / William Turner			[phone] or [e-mail] [phone] / [phone] [phone]

About Novacyt Group (www.novacyt.com)

Novacyt is an international molecular diagnostics company providing a broad portfolio of integrated technologies and services, primarily focused on the delivery of genomic medicine. The Company develops, manufactures, and commercialises a range of molecular assays and instrumentation to deliver workflows and services that enable seamless end-to-end solutions from sample to result across multiple sectors including human health, animal health and environmental.

The Company is divided into three business segments:

Clinical	Broad portfolio of human clinical in vitro diagnostic products, workflows and services focused on three therapeutic areas: ·    Reproductive Health: NIPT, Cystic Fibrosis and other rapid aneuploidy tests ·    Precision Medicine: DPYD genotyping assay ·    Infectious Diseases: Winterplex, multiplex winter respiratory PCR panel
Instrumentation	Portfolio of next generation size selection DNA sample preparation platforms and rapid PCR machines, including: ·    Ranger® Technology: automated DNA sample preparation and target enrichment technology ·     genesig q16 and q32 real-time quantitative PCR (qPCR) instruments
Research Use Only	Range of services for the life sciences industry: ·  Design, manufacture, and supply of high-performance qPCR assays and workflows for use in human health, agriculture, veterinary and environmental, to support global health organisations and the research industry ·    Pharmaceutical research services: whole genome sequencing (WGS) / whole exome sequencing (WES)

Novacyt is headquartered in Le Vésinet in France with offices in the UK (Manchester), Singapore, the US and Canada and has a commercial presence in over 65 countries, including Australia, following the recent acquisition of Southern Cross Diagnostics in March 2026, which has opened new distribution channels to the life sciences and diagnostics industries in the territory and the wider Asia-Pacific region.

The Company is listed on the London Stock Exchange's AIM market ("NCYT") and on the Paris Stock Exchange Euronext Growth ("ALNOV").

For more information, please refer to the website: www.novacyt.com

 

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