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Novacyt S.A. ("Novacyt", the "Company" or the "Group"): Approval of genesig® COVID-19 3G PCR Test in the UK Under CTDA Legislation

PARIS & EASTLEIGH, England--(BUSINESS WIRE)--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


genesig® COVID-19 Real-Time PCR

Approved November 2021


PROmate® COVID-19 2G (q32)

Approved February 2022


PROmate® COVID-19 1G (q32)

Approved April 2022


PROmate® COVID-19 1G (q16)

Approved May 2022


exsig™ COVID-19 Direct

Approved July 2022


genesig® Real-time PCR SARS-CoV-2 Winterplex

Approved 20 October 2022


genesig® COVID-19 3G Real-Time PCR

Approved 1 December 2022



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:


For further information, please refer to or contact:

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

FTI Consulting (International)
Victoria Foster Mitchell / Alex Shaw
+44 (0)20 3727 1000 / /

FTI Consulting (France)
Arnaud de Cheffontaines
+33 (0)147 03 69 48

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Last Updated: 06-Dec-2022