REG - Novacyt S.A. - Launch of Yourgene® Insight DPYD assay

Novacyt SAAnnouncement

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RNS Number : 7842E  Novacyt S.A.  19 May 2026

 

Novacyt S.A.

("Novacyt" or the "Company")

 

Launch of Yourgene® Insight DPYD assay

Paris, France and Manchester, UK - 19 May 2026 - Novacyt S.A. (EURONEXT
GROWTH: ALNOV; AIM: NCYT), an international molecular diagnostics company with
a broad portfolio of integrated technologies and services, announces the
launch of Yourgene® Insight DPYD assay, an assay utilizing genetic Insights
for safer chemotherapy treatments to align with updated testing guidelines.

 

Yourgene® Insight DPYD is a simple-to-use genotyping test that can identify
cancer patients with Dihydropyrimidine Dehydrogenase (DPD) deficiency, which
can cause severe and sometimes lethal side effects in patients being treated
with chemotherapeutic drug 5-Fluorouracil (5-FU), commonly used in the
treatment of colorectal, head and neck, breast, pancreatic and stomach
cancers. Over two million cancer patients globally are treated with
fluoropyrimidines (including 5-FU) each year; 10-20% of these patients suffer
severe, and sometimes fatal side effects associated with DPD deficiency.
Screening patients for DPYD variants allows treatments to be adjusted
accordingly.

 

Following updated guidelines from a joint consensus of organisations such as
AMP (Association for Molecular Pathology) and ACMG (American College
of Medical Genetics and Genomics), the 2019 original Yourgene® DPYD test
has been enhanced to enable the number of variants to be detected to increase
from six to 19, including the 14 recommended by these updated guidelines,
demonstrating the Company's ability to meet customer and market needs. The
product has been launched for Research Use Only (RUO) initially with In Vitro
Diagnostic Regulation (IVDR) and other regulatory territory approvals to
follow in due course. Many countries have already implemented DPYD genotyping
ahead of prescribing chemotherapy treatment and there is a mixed model of
private pay and reimbursement.

 

The Yourgene® Insight DPYD test has the same workflow and format as the
original DPYD kit, with ready-to-use reagents, simple data interpretation to
identify the presence or absence of 19 variants  and a fast turnaround time
enabling results to be provided the same day, ensuring there is no delay in
patients starting their chemotherapy treatment.

 

The Company has continued to invest in research and development to expand its
product portfolio, and it is encouraging to see this investment translating
into commercially launched products and tangible pipeline progress.

Lyn Rees, Chief Executive Officer of Novacyt, commented: "We are pleased to
have launched the Yourgene® Insight DPYD assay on schedule, enabling a
streamlined, cost-effective pharmacogenetic workflow that supports safer, more
personalised treatment decisions for cancer patients at risk of suffering a
severe, and potentially life-threatening reaction to common chemotherapy. By
listening to customer feedback and working with key opinion leaders, we have
ensured additional variants have been included in the test enhancing our
global coverage for the product, strengthening our market position. The new
kit delivers a deeper insight and greater confidence for clinical
decision-making, helping reduce adverse side effects while improving patient
safety."

 

 

Contacts

 

 Novacyt SA                                                              https://novacyt.com/investors (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)                                                    +44 (0)20 3470 0470
 Matthew Johnson / Charlie Bouverat (Corporate Finance)

 Vadim Alexandre / Rob Rees (Corporate Broking)

 Singer Capital Markets (Joint Broker)                                                                            +44 (0) 20 7496 3000
 Phil Davies / James Fischer / Samed Ethemi

 Allegra Finance (French Listing Sponsor)       +33 (1) 42 22 10 10

                                             r.durgetto@allegrafinance.com (mailto:r.durgetto@allegrafinance.com) /
 Rémi Durgetto / Yannick Petit                 y.petit@allegrafinance.com (mailto:y.petit@allegrafinance.com)

 Walbrook PR (Financial PR & IR)                                         +44 (0)20 7933 8780 or novacyt@walbrookpr.com (mailto:novacyt@walbrookpr.com)

 Paul McManus / Lianne Applegarth                                        +44 (0)7980 541 893 / +44 (0)7584 391 303

 Alice Woodings                                                           +44 (0)7407 804 654

 

About Novacyt Group (www.novacyt.com (http://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
(http://www.novacyt.com)

 

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