REG - Novacyt S.A. - UK Approval of genesig® SARS-CoV-2 Winterplex® 3G

Novacyt SAAnnouncement

26/10/2022 07:17

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RNS Number : 0989E  Novacyt S.A.  26 October 2022

 

Novacyt S.A.

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

 

Approval of genesig(®) SARS-CoV-2 Winterplex(®) 3 Gene assay panel in the UK
under CTDA legislation

 

A multiplex PCR test for the detection of winter viruses including SARS-CoV-2,
influenza A and B, and RSV

 

Paris, France and Camberley, UK - 26 October 2022 - Novacyt (EURONEXT GROWTH:
ALNOV; AIM: NCYT), an international specialist in clinical diagnostics,
announces that the Company's genesig(®) Real-Time PCR SARS-CoV-2
Winterplex(®) 3G assay panel (Winterplex(®) 3G) 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
sixth PCR test to be added to the CTDA register of approved COVID-19
diagnostic products.

 

Winterplex(®) 3G is a high throughput multiplex screening assay (with 96
reactions per kit) for the detection of influenza A, influenza B, respiratory
syncytial virus (RSV), and SARS-CoV-2 (COVID-19) (specifically the detection
of ORF1ab, S and M genes targets) from oropharyngeal, nasopharyngeal or sputum
samples.

 

This approval comes in advance of the winter virus season in the northern
hemisphere and means the Company can now sell Winterplex(®) 3G in the UK.
Winterplex(®) 3G allows healthcare systems to differentiate between common
respiratory infections which present with similar symptoms. As the prevalence
of winter viruses increases, Novacyt continues to monitor all strains of
influenza A, influenza B, RSV and SARS-CoV-2 through its bioinformatics
surveillance programme.

 

David Allmond, Group CEO of Novacyt, commented:

"We are pleased Winterplex(®) 3G has been approved under the UK's CTDA
legislation. This product is a combined assay which offers the benefit of
testing for multiple seasonal viruses at the same time, saving time and
requiring only one patient sample. We believe this is important as the
diagnostics market moves towards favouring respiratory panels over
COVID-19-specific testing due to concerns about the dual rise in COVID-19 and
influenza cases this winter. 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 respiratory 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             Pending evaluation

 8   PathFlow(®) COVID-19 Rapid Antigen Pro

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

 

- End -

 

Contacts

Novacyt SA

David Allmond, Chief Executive Officer

James McCarthy, Chief Financial 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's lead business units comprise of
Primerdesign and Lab21 Products, supplying 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.co
(http://www.novacyt.com) m

 

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