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
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Novacyt SA |
https://novacyt.com/investors |
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Lyn Rees, Chief Executive Officer |
Via Walbrook PR |
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Steve Gibson, Chief Financial Officer
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SP Angel Corporate Finance LLP (Nominated Adviser and Broker) |
+44 (0)20 3470 0470 |
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Matthew Johnson / Charlie Bouverat (Corporate Finance) Vadim Alexandre / Rob Rees (Corporate Broking) |
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Deutsche Numis (Joint Broker) |
+44 (0)20 7260 1000 |
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Freddie Barnfield / Duncan Monteith / Michael Palser |
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Allegra Finance (French Listing Sponsor) Rémi Durgetto / Yannick Petit |
+33 (1) 42 22 10 10 [email protected] / [email protected] |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Paul McManus / Phillip Marriage / Alice Woodings |
+44 (0)20 7933 8780 or [email protected] +44 (0)7796 794 663 / +44 (0)7980 541 893 +44 (0)7867 984 082 / +44 (0)7407 804 654 |
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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:
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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
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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
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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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