Novacyt S.A. ("Novacyt", the "Company" or the "Group"): Approval of the First Direct-to-PCR COVID-19 Test in the UK Under CTDA Legislation
17 Februar 2022 - 8:00AM
Business Wire
Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international
specialist in clinical diagnostics, announces that the Company’s
PROmate® COVID-19 2G 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 PROmate® COVID-19 2G test is the first direct-to-PCR product
to be added to the CTDA register of approved products and is
designed to detect two SARS-CoV-2 targets within ORF1ab in response
to an increasing shift from single-gene to multi-gene testing
solutions. Direct-to-PCR products remove the need for complex,
manual or automated extraction solutions and are designed to
significantly improve laboratory workflow and reduce costs. It also
allows testing to take place away from traditional,
laboratory-based settings due to simplicity and ease of use.
Therefore, the PROmate® COVID-19 2G PCR test is well suited for
industries such as travel, sport, film, media, and workplace
settings.
The validation of the PROmate® COVID-19 2G test follows the UK
approval of the Company’s COVID-19 genesig® Real-Time PCR test
under the CTDA, as announced on 26 November 2021. In addition, as
previously announced, Novacyt’s PROmate® COVID-19 1G Real-Time PCR
test, currently being supplied to the NHS under a National
Microbiology Framework, remains on the temporary protocol list (due
to expire on 28 February 2022) and the Company awaits further
updates on an additional seven products submitted to the CTDA
across its COVID-19 testing portfolio.
David Allmond, Group CEO of Novacyt, commented: “Our
PROmate® COVID-19 range offers a unique combination of workflow
efficiency, results in as little as 80 minutes and exceptional
clinical performance, optimised for both our genesig® q16 and q32
instruments. It provides total viral inactivation, with a
ready-prepared mix containing internal control for run validity,
meaning there is no need for a category 2 laboratory to handle the
live virus, thereby removing handling risk and bringing the test
nearer to patients. With this approval from the CTDA, we can
continue to meet the demand for high quality COVID-19 testing in
the UK.”
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/20220216006236/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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