REG - Novacyt S.A. - IVDR certification for DPYD genotyping assay

Novacyt SAAnnouncement

07/11/2023 07:00

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RNS Number : 5611S  Novacyt S.A.  07 November 2023

 

Novacyt S.A.

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

 

IVDR certification achieved for DPYD genotyping assay

One of the first products of its kind to conform with new IVDR requirements

 

Paris, France, and Eastleigh and Manchester, UK - 7 November 2023 - Novacyt
S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in
clinical diagnostics, confirms IVDR accreditation under the new EU
requirements of the In Vitro Diagnostic Regulation ("IVDR") for its DPYD
genotyping assay, which supports the identification of cancer patients at risk
of suffering a severe, and potentially life-threatening, reaction to common
chemotherapy.

 

The Yourgene® DPYD assay is used to identify patients with Dihydropyrimidine
Dehydrogenase (DPD) deficiency, through the rapid detection of six clinically
relevant variants in the DPD enzyme. Patients with a DPD deficiency have a
high risk of severe, and sometimes lethal, side effects following the
administration of 5-Fluorouracil (5-FU), a widely used chemotherapy agent used
in the treatment of many cancers including colorectal, head and neck, breast,
pancreatic and stomach cancer.

 

An estimated two million people globally are treated with fluoropyrimidines
(including 5-FU) each year(1), with between 10-30% of these patients suffering
severe side effects associated with DPD deficiency(2). DPYD genotyping for
5-FU toxicity has been adopted in many countries internationally with
screening introduced into cancer care clinical pathways following government
reimbursement in England, Wales, Germany, Spain, Belgium and the Ontario
province of Canada. The screening enables clinicians to reduce the risk of
increased toxicity from 5-FU exposure in these patients by treatment with a
lower dose, or with an alternate drug therapy where indicated.

 

The Yourgene® DPYD assay is a Class C in vitro medical device under IVDR and
is intended for use by healthcare professionals within a molecular or oncology
laboratory environment.

 

The new IVDR ensures that in vitro diagnostic devices manufactured for sale in
the EU are assessed against stringent quality, safety and performance
requirements. Manufacturers must provide, among other things, considerable
evidence of scientific validity, as well as data demonstrating analytical and
clinical performance of the devices. The DPYD assay was assessed by BSI, an
independent conformity assessment body (the "Notified Body") and was shown to
conform to the new regulations.

 

The DPYD assay is the first product within the now enlarged Novacyt product
portfolio to conform to the new EU IVDR and is one of the first
pharmacogenomics tests in the market, and the only assay for the rapid
detection of the six clinically relevant variants in the DPD enzyme, as
defined by the CPIC* guidelines, to conform to IVDR. The Directors of Novacyt
believe that conformity with IVDR provides clinicians and patients with
additional confidence in the high-quality and accuracy of this test, which is
increasingly becoming an essential screening requirement ahead of cancer
patient treatment.

 

Commenting James McCarthy, Acting Chief Executive Officer, said: "We are
delighted to announce the first conformity of one of our products to the new
EU regulations for in vitro diagnostic products. This success reflects the
high-quality of the product in terms of both performance and safety, and
follows a rigorous review by our Notified Body. It is a clear market advantage
to have our product as the first assay to detect DPD deficiency to conform to
IVDR, particularly as more and more countries in Europe and elsewhere are
adopting this form of screening as their recommended procedure ahead of
chemotherapy treatment."

 

Sources

(1) D. Meulendijks et al./Cancer Treatment Reviews 50 (2016) 23-34

(2) Cancer Research UK https://bit.ly/2kLn1uT (https://bit.ly/2kLn1uT)

*CPIC Guidelines (Clinical Pharmacogenetics Implementation Consortium)
provides clinical dosing recommendations based on DPYD genotype for patients
https://cpicpgx.org/guidelines/guideline-for-fluoropyrimidines-and-dpyd/
(https://cpicpgx.org/guidelines/guideline-for-fluoropyrimidines-and-dpyd/)

 

Contacts

 

 Novacyt SA                                                              https://novacyt.com/investors (https://novacyt.com/investors/)
 James Wakefield, Non-Executive Chairman                                  Via Walbrook PR

 James McCarthy, Acting Chief Executive 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

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

 Stephanie Cuthbert / Anna Dunphy /                                      +44 (0)7796 794 663/ +44 (0)7876 741 001

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

 

About DPYD

https://yourgenehealth.com/our-products/assays-and-applications/precision-medicine/dpyd-genotyping/
(https://yourgenehealth.com/our-products/assays-and-applications/precision-medicine/dpyd-genotyping/)

 

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

Novacyt is an international diagnostics business delivering a broad portfolio
of in vitro and molecular diagnostic tests for a wide range of infectious
diseases, enabling faster, more accurate, accessible testing to improve
healthcare outcomes. The Company provides customers with a seamless
sample-to-result workflow using its integrated and scalable
instrumentation/solutions. The Company specialises in the design, manufacture,
and supply of real-time PCR kits, reagents and a full range of laboratory and
qPCR instrumentation for molecular biology research and clinical use. Novacyt
offers one of the world's most varied and comprehensive range of qPCR assays,
covering human, veterinary, biodefence, environmental, agriculture and food
testing.

 

The acquisition of Yourgene in September 2023 added a complementary
international genomics technology and services business, focussed on
delivering accurate molecular diagnostic and screening solutions, across
reproductive health and precision medicine. Yourgene's portfolio of in vitro
diagnostic products includes non-invasive prenatal tests (NIPT) for Down's
Syndrome and other genetic disorders, Cystic Fibrosis screening tests,
invasive rapid aneuploidy tests and DPYD genotyping assays. Yourgene also
works in partnership with global leaders in DNA technology to allow its
Ranger® Technology to deliver dynamic target enrichment.

 

Novacyt is headquartered in Vélizy in France with offices in the UK in
Stokesley, Eastleigh and Manchester. The Company also has offices in Taipei
(divestment pending), Singapore, the US and Canada and is listed on the London
Stock Exchange's AIM market ("NCYT") and on the Paris Stock Exchange Euronext
Growth ("ALNOV").

 

 

 

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