Novacyt S.A. : Manufacturing and R&D update for COVID-19 test
15 Abril 2020 - 12:15PM
Business Wire
Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt" or the
"Company"), an international specialist in clinical diagnostics,
provides a manufacturing, and research and development update on
its polymerase chain reaction (PCR) test for COVID-19, developed by
Primerdesign, the Company’s molecular diagnostics division based in
the UK.
Manufacturing capacity
Novacyt is focused on managing what it believes will be a period
of sustained, significant demand for its COVID-19 test. The value
of the current order book, anticipated sales contracts and the
growing number of potential orders means further significant
commitments to manufacturing capacity are being made.
Further to the announcement on 30 March 2020, Primerdesign has
now achieved the target run-rate of manufacturing its COVID-19 test
at a rate of four million tests per month. To continue to meet
demand, the Company is working to further increase this
manufacturing capacity and has signed manufacturing partnership
agreements with BioPharma Process Services Ltd and Biofortuna
Limited, both based in the UK, to support its existing partnership
agreements. In addition, Novacyt continues to scale-up its own
production at its Primerdesign site in Southampton, UK. With this
additional capacity, the Company expects, over the next three
months, to increase production of the test to approximately eight
million tests per month.
As part of Novacyt’s ongoing evaluation of additional capacity
options, the Company is also in discussions with further potential
UK-based manufacturing partners.
In order to manage and support the planning, procurement and
logistics for this capacity increase, Novacyt has engaged Chartwell
Consulting, a specialist in rapid process improvement
(www.chartwell-consulting.com). Chartwell has a team of senior
consultants working within Novacyt to assist with the management of
the scale-up plans to help deliver the planned increases in
Primerdesign’s production, and supply chain capacity.
Given the planned increase in production, the Company has begun
ordering additional raw materials to support this expansion. The
Company is also expanding its key raw material supplier base for
its COVID-19 test. Currently there are a total of 76 components
required for its COVID-19 test and Chartwell is helping the Company
to identify additional suppliers in order to develop a long-term
and sustainable supply of its kits at this volume.
Research and development update
Novacyt has been working to address the current reported
shortfall in extraction reagents required to perform PCR testing
through the development of a new “direct-to-PCR” extraction method
prior to running the Company’s COVID-19 test. This removes the need
for some scarce reagents and significantly reduces the number of
extraction steps, allowing faster cycle times, higher throughputs
and cost savings. The Directors believe this innovation should
facilitate an increase in testing capacity for COVID-19, removing a
current bottleneck in sample processing for laboratories. Novacyt
expects to have this new extraction technology available to launch
in May 2020.
Graham Mullis, Chief Executive Officer of Novacyt,
commented:
“Our primary focus today is to expand Primerdesign’s
manufacturing capacity as quickly as possible to service the
continued significant demand for our COVID-19 test. Whilst we are
delighted with the progress we have made in ramping-up
manufacturing capacity, we need to expand this further and are
therefore putting in place plans to ensure we can continue to
support our growing order book. This includes the appointment of a
specialist consulting company to focus on operational efficiency,
which will enable Novacyt to build a larger, sustainable
supply-chain. I would like to thank our manufacturing partners and
suppliers for their support during this pandemic.”
Andy Redfern, Partner at Chartwell Consulting,
commented:
“We are delighted to partner with Novacyt and work with its
manufacturing and supply chain team to deliver a significant
increase in throughput of an important test for COVID-19. The scale
and pace of the ramp-up in manufacturing capacity is crucial as we
support Novacyt in continuing to meet the demand for its COVID-19
test.”
Novacyt has also received emergency use approval for its test
from the Federal Drug Agency of Saudi Arabia and from the National
Agency of Drug and Food Control of the Republic of Indonesia, as
well as import approval from the Drugs Controller General of
India.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
- End –
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 +33 (0)147 03 69 47
arnaud.decheffontaines@fticonsulting.com
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