Novacyt S.A. ("Novacyt", the "Company" or the "Group"): Approval of exsig™ COVID-19 Direct Test in the UK Under CTDA Legislation
July 15 2022 - 2:00AM
Business Wire
Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international
specialist in clinical diagnostics, announces that the Company’s
exsig™ COVID-19 Direct 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").
The exsig™ COVID-19 Direct Real-Time PCR test is designed to
detect a SARS-CoV-2 gene target within ORF1ab and, as with all the
Company’s direct-to-PCR products, removes the need for manual or
automated extraction solutions to significantly improve laboratory
workflow and reduce costs. In addition, the test is designed for
use on an open platform, meaning it can be used with the Company’s
q16 and q32 instruments, as well as other validated systems. The
test is the Company’s fifth PCR product to be added to the CTDA
register of approved products.
David Allmond, Group CEO of Novacyt, commented:
“To ensure Novacyt is well positioned for any future COVID-19
outbreaks, the Company continues to consolidate its portfolio. The
approval of exsig™ COVID-19 Direct supports this aim, complementing
the Company’s existing PCR portfolio for COVID-19 testing in the UK
and further reinforcing Novacyt’s position as a first responder in
infectious diseases.”
The status of 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® COVID-19 3G Real-Time
PCR
7
genesig® Real-time PCR SARS-CoV-2
Winterplex
Pending evaluation
8
PathFlow® COVID-19 Rapid Antigen
Pro
9
PathFlow® COVID-19 Rapid Antigen
Self-Test
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.com
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version on businesswire.com: https://www.businesswire.com/news/home/20220714005903/en/
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 Securities Limited (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
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