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REG - Novacyt S.A. - Launch of COVID-19 antibody test

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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
(mailto:victoria.fostermitchell@fticonsulting.com) /
mary.whittow@fticonsulting.com (mailto:mary.whittow@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.com
(http://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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