Novacyt Regulatory News (NCYT)

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."

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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:

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