Novacyt S.A.: Update on Novel Coronavirus Test
07 Février 2020 - 8:00AM
Business Wire
Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt", the
"Company" or the “Group”), an international specialist in clinical
diagnostics, provides an update following the launch of its
research use only (RUO) test for novel coronavirus (2019-nCoV),
which has been developed by its subsidiary Primerdesign as a direct
response to the recent outbreak of the respiratory virus in
China.
Since the World Health Organization declared the 2019-nCoV
outbreak a global emergency on the 30 January 2020, the Company has
seen strong demand for its nCoV test, which was launched on 31
January 2020. To date, Primerdesign has received orders for 33,000
tests and requests for quotations for another 32,000 tests from
over 30 countries, with a high conversion rate from quotations to
orders. The Directors believe the Company is well placed to support
the growing global demand for nCoV testing.
The Company is also pleased to announce it is planning to launch
a CE-Mark approved nCoV test in the week commencing 17 February.
This approval will mean the nCoV test can be used for clinical
diagnostic testing, as well as expanding its use within
laboratories. The Directors believe that Primerdesign will be one
of the first companies to market its test with CE-Mark
approval.
In addition, the Company has applied to the US Food and Drug
Administration (FDA) for Emergency Use Approval (EUA) of its nCoV
test. EUA approval would allow laboratories in the US to use the
nCoV test for clinical diagnosis on a temporary basis. The Company
is working with the FDA in order to demonstrate the consistency and
performance of the Primerdesign test for emergency use.
The Company is also in discussions with various NHS hospitals
and Public Health England regarding the nCoV test and it has
already sold a limited number of tests to certain hospitals for
their validation purposes.
As previously announced, the Primerdesign nCoV test is designed
to detect only the 2019 strain of the virus, which the Directors
believe differentiates it from a number of current tests which are
less specific and could, therefore, react to other related viruses,
potentially giving rise to a false diagnosis. The Primerdesign test
can generate a result in less than two hours meaning that all
samples can be screened quickly, which could help stop the
unnecessary spread of this virus. The test is also stable at
ambient temperatures, which eliminates the need for cold chain
shipping in tropical climates and therefore improves the efficiency
of the test and reduces transport costs.
Graham Mullis, Chief Executive Officer of Novacyt
commented: “It is still early days in this public health
emergency, however coronavirus has already been reported in 23
countries with more than 28,000 reported infections. As one of the
first companies to develop and launch a test to detect the 2019
strain of nCoV, we have received unprecedented interest in our test
and anticipate demand continuing to grow. In addition, we look
forward to launching our CE-Mark approved nCoV test, which we
believe provides laboratories with a fast and reliable nCoV test
without the need to carry out their own validation. We continue to
support our new and existing customers and are working with the
various regulatory authorities to try to make our nCoV test
available to as many countries and laboratories as possible to
support clinicians in reducing the spread of the disease.”
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
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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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
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 / Astrid
Villette +33 (0)147 03 69 47 / +33 (0)147 03 69 51
arnaud.decheffontaines@fticonsulting.com /
astrid.villette@fticonsulting.com
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