TIDMNCYT
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(R) 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(R) 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
*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/
Contacts
Novacyt SA https://novacyt.com/investors
James Wakefield, Non-Executive Via Walbrook PR
Chairman
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 +33 (1) 42 22 10 10
Sponsor) r.durgetto@allegrafinance.com /
Rémi Durgetto / Yannick y.petit@allegrafinance.com
Petit
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/
About Novacyt Group ( 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(R) 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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