Novacyt S.A. Launch of COVID-19 antibody test (3706A)
September 29 2020 - 01:00AM
UK Regulatory
TIDMNCYT
RNS Number : 3706A
Novacyt S.A.
29 September 2020
Novacyt S.A.
("Novacyt" or the "Company")
Launch of COVID-19 antibody test
Paris, France and Camberley, UK - 29 September 2020 - Novacyt,
an international specialist in clinical diagnostics, announces
that, further to the announcement on 27 July 2020, the Company has
launched a CE-Mark approved serology (antibody) 96-well plate ELISA
(enzyme-linked immunosorbent assay) test for the detection of IgG
antibodies to SARS-CoV-2 derived from plasma and serum samples.
The test has been launched by Microgen Bioproducts Limited
(Microgen), which is part of Novacyt's protein diagnostics division
Lab21. The new antibody test complements Novacyt's existing
COVID-19 product portfolio, in particular the Company's polymerase
chain reaction (PCR) test for COVID-19, to provide clinicians with
the diagnostic tools to detect and differentiate between active and
prior SARS-CoV-2 infections in patients.
The new antibody test has been validated in a study where 1,673
patient samples (112 positive samples and 1,561 negative samples)
were evaluated. The test demonstrated 100% sensitivity in patients
that were tested at 14 days after testing positive for COVID-19 by
a PCR test. The antibody test also demonstrated 99.4%
specificity.
The ELISA test has been designed for use in all established
central laboratories and follows a standard ELISA protocol that
makes it compatible with most 96-well plate automation systems.
Novacyt has sufficient manufacturing capacity to deliver more than
three million antibody tests per month initially and the Company is
working with its manufacturing partner to ensure this can be
increased depending on demand.
Graham Mullis, Chief Executive Officer of Novacyt,
commented:
"Novacyt remains committed to supporting the global response to
COVID-19 through the delivery of high performance diagnostics. We
continue to strengthen our product offering in COVID-19 testing as
demand continues and we are delighted to launch an antibody test.
We believe an antibody test plays an important role in aiding the
diagnosis of COVID-19, as well as increasing our understanding of
the disease through screening of populations for infection rates
and immunity ."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
- End -
Contacts
Novacyt SA
Graham Mullis, Chief Executive Officer
Anthony Dyer, 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
FTI Consulting (International)
Victoria Foster Mitchell / Mary Whittow
+44 (0)20 3727 1000
victoria.fostermitchell@fticonsulting.com /
mary.whittow@fticonsulting.com
FTI Consulting (France)
Arnaud de Cheffontaines
+33 (0)147 03 69 48
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.com
About COVID-19
Researchers at the Chinese Centre for Disease Control and
Prevention and their collaborators have sequenced the 2019 novel
coronavirus (COVID-19) pathogen from patient samples and have found
it to be genetically distinct from the severe acute respiratory
syndrome (SARS) virus that caused an epidemic in 2002 and 2003, as
well as from the Middle East respiratory syndrome (MERS) virus that
was detected in 2012.
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END
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