REG - Novacyt S.A. - IVDR accreditation for Yourgene QST*R Base assay

Novacyt SAAnnouncement

20/02/2025 07:15

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RNS Number : 7690X  Novacyt S.A.  20 February 2025

 

Novacyt S.A.

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

 

IVDR accreditation for Yourgene® QST*R Base assay

 

Paris, France, and Manchester, UK - 20 February 2025 - 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® QST*R Base assay. The
Yourgene® QST*R Base is a Class C in vitro medical device under IVDR and is
intended for use by healthcare professionals within a molecular laboratory
environment.

 

Yourgene® QST*R Base is a highly multiplexed, single tube assay containing
22 markers for rapid diagnosis of the common autosomal and sex chromosome
aneuploidies during pregnancy. For those women identified as being at high
risk of carrying a fetus with one of these conditions, chorionic villus
sampling (10-12 weeks) or amniocentesis (14-18 weeks) is offered and QST*R
Base would then be used by the laboratory. Autosomal markers are used to
detect the three most common viable autosomal trisomies: trisomy 21 (Down's
syndrome), trisomy 18 (Edwards' syndrome) and trisomy 13 (Patau's syndrome).
The chosen markers are highly informative with results obtained in >99% of
samples.

 

IVDR ensures that the Yourgene® QST*R Base assay, 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® QST*R Base assay was assessed by British Standards
Institution (BSI), an independent conformity assessment body, and was shown to
conform to the new regulations.

 

Lyn Rees, CEO of Novacyt, commented: "This is the third IVDR accreditation for
Novacyt which further demonstrates the high quality and accuracy of our
products, and our team's ability to navigate the stringent new regulatory
environment for in vitro diagnostic tests. Novacyt has a range of tests for
the reproductive health lifecycle and the QST*R Base test is complementary to
our NIPT tests providing a follow-on confirmatory test after a high risk NIPT
result. We are very proud to have developed an assay that provides accurate
and reliable results during a stressful time in the pregnancy for expecting
parents."

 

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)

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

 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 Le Vésinet in France with offices in the
Manchester, UK, 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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