Novacyt S.A. ("Novacyt", the "Company" or the "Group"): Approval of genesig® COVID-19 3G PCR Test in the UK Under CTDA Legislation
06 12월 2022 - 4:00PM
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
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
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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
Novacyt (EU:ALNOV)
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Novacyt (EU:ALNOV)
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부터 12월(12) 2023 으로 12월(12) 2024
