REG - Novacyt S.A. - IVDR accreditation

Novacyt SAAnnouncement

17/10/2024 07:00

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RNS Number : 5085I  Novacyt S.A.  17 October 2024

 

Novacyt S.A.

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

 

IVDR accreditation for Yourgene® Cystic Fibrosis Base assay

 

Paris, France, Eastleigh and Manchester, UK - 17 October 2024
- Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international molecular
diagnostics company with a broad portfolio of integrated technologies and
services, announces that it has received accreditation under the new EU
requirements of the In Vitro Diagnostic Regulation ("IVDR") for the Yourgene®
Cystic Fibrosis Base assay. The Yourgene® Cystic Fibrosis Base assay is a
Class C in vitro medical device under IVDR and is intended for use by
healthcare professionals within a molecular laboratory environment.

 

IVDR ensures that the Yourgene® Cystic Fibrosis Base test, which is
manufactured for sale in the EU, is assessed against stringent quality, safety
and performance requirements. Manufacturers must provide considerable evidence
of scientific validity, as well as data demonstrating analytical and clinical
performance of the tests. The Yourgene® Cystic Fibrosis Base test was
assessed by British Standards Institution (BSI), an independent conformity
assessment body, and was shown to conform to the new regulations.

 

Cystic Fibrosis ("CF") has become the most common life-shortening hereditary
genetic condition affecting 1 in 2,500 live births in Caucasians. In the UK,
all newborns are screened for CF as part of the newborn blood spot test. The
test is performed within the first three days of a baby's life and involves
pricking the baby's heel and collecting a few drops of blood on a card. The
blood is then tested for CF and other rare conditions. The Yourgene® Cystic
Fibrosis Base assay uses Amplification-Refractory Mutation System technology
and genetic analysers to detect point mutations, insertions or deletions in
DNA. The assay is designed with all clinically relevant diagnostic scenarios
in mind such as carrier screening, newborn screening and male factor
infertility testing.

 

The Yourgene® Cystic Fibrosis Base test, part of Yourgene's Reproductive
Health portfolio, is used to identify patients with any of the 50 most common
CF mutations in the European population.

 

Lyn Rees, CEO of Novacyt, commented: "This is the second product within the
now enlarged Novacyt product portfolio to conform to the new EU IVDR
regulations and is one of the first IVDR CF tests on the market. Conformity
with IVDR provides clinicians and patients with additional confidence in the
high-quality and accuracy of our test which is increasingly becoming an
essential test in the detection and diagnosis of CF.

 

"CF testing is prevalent globally and there has recently been an increase in
some regions due to increased reimbursement. This includes Australia where the
Australian government have introduced a nationwide reimbursement pathway that
enables all eligible Australians to receive CF screening either prior to, or
early in pregnancy. With increasing momentum in this market, the IVDR
accreditation only further validates the quality of our test within the EU and
beyond."

 

 

 

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)

 Deutsche Numis (Joint Broker)                                                                                    +44 (0)20 7260 1000
 Freddie Barnfield / Duncan Monteith / Michael Palser

 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)

 Stephanie Cuthbert / Paul McManus /                                     +44 (0)7796 794 663 / +44 (0)7980 541 893

 Phillip Marriage / Alice Woodings                                        +44 (0)7867 984 082 / +44 (0)7407 804 654

 

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 Vélizy-Villacoublay in France with offices in the
UK (in Eastleigh and Manchester), Singapore, the US and Canada and has a
commercial presence in over 65 countries. 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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