REG - Novacyt S.A. - Approval of genesig COVID-19 3G PCR test in UK

Novacyt SAAnnouncement

06/12/2022 07:00

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RNS Number : 6734I  Novacyt S.A.  06 December 2022

 

Novacyt S.A.

 

("Novacyt", the "Company" or the "Group")

 

Approval of genesig(®) COVID-19 3G PCR test in the UK under CTDA legislation

 

Paris, France and Eastleigh, UK - 6 December 2022 - 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   PathFlow(®) COVID-19 Rapid Antigen Pro           Pending evaluation

 9   PathFlow(®) COVID-19 Rapid Antigen Self-Test

 

 

- End -

 

For further information, please refer to www.novacyt.com
(http://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 (mailto:r.durgetto@allegrafinance.com) /
y.petit@allegrafinance.com (mailto:y.petit@allegrafinance.com)

 

FTI Consulting (International)

Victoria Foster Mitchell / Alex Shaw

+44 (0)20 3727 1000

victoria.fostermitchell@fticonsulting.com
(mailto:victoria.fostermitchell@fticonsulting.com) /
Alex.Shaw@fticonsulting.com (mailto:Alex.Shaw@fticonsulting.com) /
Novacyt.group@fticonsulting.com (mailto:Novacyt.group@fticonsulting.com)

 

FTI Consulting (France)

Arnaud de Cheffontaines

+33 (0)147 03 69 48

arnaud.decheffontaines@fticonsulting.com
(mailto:arnaud.decheffontaines@fticonsulting.com)

 

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
(http://www.novacyt.com)

 

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