Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that the Company's genesig COVID-19 3G Real-Time PCR test has been approved in the UK under the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA"), making it the Company's seventh PCR test to be added to the CTDA register of approved COVID-19 diagnostic products.
The genesig COVID-19 3G test, CE marked in April 2021, is designed to detect three separate SARS-CoV-2 gene targets (ORF1ab, M gene, and S genes) from combined nasal and oropharyngeal sample types. As seen during the COVID-19 pandemic, the prevalence of mutations with biological significance within the spike protein of SARS-CoV-2 meant the need to test for more than one gene target at a time increased.
James McCarthy, Acting Group CEO of Novacyt, commented:
"The approval of our COVID-19 3G test, our seventh product to be approved under the UK's CTDA legislation, reinforces the market-leading quality of our tests. We believe the ability of our COVID-19 3G test to simultaneously target three separate genes within SARS-CoV-2 provides a highly accurate option for detection. This latest approval ensures we are well-positioned with our consolidated COVID-19 portfolio for any potential future outbreaks and as we continue to focus on our wider diagnostic product offering as part of our growth strategy."
The status of the Company's current CTDA submissions is as follows:
| Product name | Current CTDA status |
1 | genesig COVID-19 Real-Time PCR | Approved November 2021 |
2 | PROmate COVID-19 2G (q32) | Approved February 2022 |
3 | PROmate COVID-19 1G (q32) | Approved April 2022 |
4 | PROmate COVID-19 1G (q16) | Approved May 2022 |
5 | exsig COVID-19 Direct | Approved July 2022 |
6 | genesig Real-time PCR SARS-CoV-2 Winterplex | Approved 20 October 2022 |
7 | genesig COVID-19 3G Real-Time PCR | Approved 1 December 2022 |
8 9 | PathFlow COVID-19 Rapid Antigen Pro PathFlow COVID-19 Rapid Antigen Self-Test | Pending evaluation |
About Novacyt Group
The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company supplies an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.
For more information, please refer to the website: www.novacyt.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20221205005797/en/
Contacts:
For further information, please refer to www.novacyt.com or contact:
Contacts
Novacyt SA
James Wakefield, Non-Executive Chairman
James McCarthy, Acting Chief Executive Officer
+44 (0)1276 600081
SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Matthew Johnson Charlie Bouverat (Corporate Finance)
Vadim Alexandre Rob Rees (Corporate Broking)
+44 (0)20 3470 0470
Numis (Joint Broker)
Freddie Barnfield James Black
+44 (0)20 7260 1000
Allegra Finance (French Listing Sponsor)
Rémi Durgetto Yannick Petit
+33 (1) 42 22 10 10
r.durgetto@allegrafinance.com/ y.petit@allegrafinance.com
FTI Consulting (International)
Victoria Foster Mitchell Alex Shaw
+44 (0)20 3727 1000
victoria.fostermitchell@fticonsulting.com Alex.Shaw@fticonsulting.com Novacyt.group@fticonsulting.com
FTI Consulting (France)
Arnaud de Cheffontaines
+33 (0)147 03 69 48
arnaud.decheffontaines@fticonsulting.com
