TIDMNCYT
RNS Number : 3501F
Novacyt S.A.
16 November 2020
Novacyt S.A.
("Novacyt", the "Company" or the "Group")
R&D Update
Continued expansion of COVID-19 product portfolio to address
unmet market needs
Paris, France and Camberley, UK - 16 November 2020 - Novacyt (
EURONEXT GROWTH: ALNOV; AIM: NCYT ), an international specialist in
clinical diagnostics, announces an R&D update.
R&D highlights
-- Encouraging interim data from ongoing clinical trial in care
homes confirms accuracy of Novacyt's near-patient testing (NPT)
system compared to central laboratory testing of COVID-19
-- Launch of PROmate(TM), a new product to improve the workflow
efficiency of Novacyt's NPT system for COVID-19 testing
-- Development of a l oop-mediated isothermal amplification ( LAMP) test for COVID-19
-- Development of an antibody lateral flow test (LFT) for COVID-19
-- Development of a research-use-only (RUO) test for a new strain of COVID-19
Novacyt's near-term focus remains to deliver strong organic
revenue growth in the core business, where the Directors believe
demand for its products will continue to grow well into 2021 as
COVID-19 testing continues. In the medium-term, Novacyt expects to
leverage its reputation, market intelligence and relationships
developed during the COVID-19 response to commercialise new
products, as well as expand its presence in respiratory and
transplant clinical diagnostics, to continue to meet significant
unmet market needs.
As part of Novacyt's strategy, the Company also continues to
invest in developing its IP portfolio to enhance and secure future
value and has submitted 15 new patents covering various aspects of
its COVID-19 portfolio.
Clinical trial update using Novacyt's NPT system in care
homes
Further to the announcement on 22 July 2020, Queen Mary
University of London (QMUL) has completed an interim review of the
performance of the Company's innovative near-patient testing (NPT)
system in an ongoing study testing for COVID-19 in care homes.
The interim review analysed over 4,000 samples from care home
residents and staff, with 98% of the samples using Novacyt's NPT
system processed and reported in the same day. The clinical
accuracy of Novacyt's NPT system was found to have >99% clinical
sensitivity and specificity when compared to a standard central
laboratory system. These data demonstrate the reliability and
accuracy of Novacyt's NPT system. In addition, mid-nose nasal
swabs
were found to be effective and well tolerated compared to the more invasive nasopharyngeal swabs.
Further to the announcement of Novacyt's second contract with
the UK DHSC on 29 September 2020 for the supply of q16 and q32
instruments and test kits to NHS hospitals, the clinical trial is
being expanded into additional settings across the UK where the
Company's NPT systems are being deployed.
Launch of PROmate(TM)
PROmate(TM) is a new CE Mark approved product designed to
further improve the workflow efficiency of COVID-19 testing when
used in combination with the Company's q16 and q32 instruments. The
reagents involved in the Company's COVID-19 RNA extraction and PCR
test products have been repackaged, with some reagents also
freeze-dried, to reduce the amount of consumables and the number of
steps required, thereby reducing operator complexity and improving
cycle times. In addition, PROmate(TM) uses a viral inactivation
methodology validated by P ublic H ealth E ngland for potential use
outside of laboratory environments.
As Novacyt's NPT system continues to be deployed across the NHS,
and globally, this improvement in workflow efficiency for COVID-19
testing is expected to make the system one of the quickest and
easiest to use PCR platforms in its class.
Further to the announcement on 15 October 2020 when Novacyt
acquired IT-IS International, the Company has significantly
increase d the manufacturing capability of IT-IS to manage the
growing demand for its q16 and q32 instruments. From November 2020,
the Company has scaled-up manufacturing capacity for instrument
production more than five-fold, with further expansion planned,
depending on continued demand.
Development of a LAMP COVID-19 test
L oop-mediated isothermal amplification ( LAMP ) technology is a
single-tube technique for the amplification of DNA and RNA and is
considered a low-cost alternative to detect certain diseases ,
including COVID-19. I sothermal amplification is carried out at a
constant temperature without the need for a thermal cycler,
contrast ing to PCR amplification, which is carried out with a
series of alternating temperature steps or cycles in a thermal
cycler .
Novacyt is currently developing a LAMP test for COVID-19,
including evaluating the trade-off between cycle time and test
performance . The Company expects to launch the product during Q1
2021 with an expected cycle time of 20 minutes or lower. Novacyt's
LAMP offering is designed to be compatible with its q16 and q32
instruments . The Company is also in active discussions with
several potential partners who are seeking support to develop,
manufacture and supply LAMP tests for their instrument
platforms.
Development of an antibody lateral flow test for COVID-19
On 29 September 2020, Novacyt announced the launch of its IgG
specific antibody test for use in central laboratory testing. The
Company is also working on developing an IgG antibody lateral flow
test (LFT) for use as a rapid antibody test for professional use.
An LFT is an easy-to-use diagnostic device used to confirm the
presence or absence of a pathogen or biomarker. The product is
expected to launch during Q1 2021 and is expected to take
approximately 20 minutes or less to give a result.
Development of a RUO test for a new strain of COVID-19
Further to the identification of a mutation of COVID-19 in
Danish mink, Novacyt has taken the strategic decision to develop a
research-use-only (ROU) PCR test for a specific new strain of the
virus. The analysis currently available suggests there are four
mutations that have been found in mink. One of the mutations, known
as Y453F , is of potential concern to scientists and clinicians as
it causes an amino acid change which affects antibody binding. This
could have implications for vaccine strategies , which are
predicated on stimulating a defined antibody response to the virus
(1) .
While it is unknown what, if any, impact the amino acid
modification will have on vaccines, Novacyt believes a RUO test
could help scientists and clinicians to identify patients that
carry the virus with the Y453F mutation. The Company expects to
launch this novel test in December 2020 . Should a clinical need
arise for the diagnostic differentiation of Y453F from other
strains of COVID-19 infection, Novacyt will be well positioned to
offer this as a clinical use diagnostic product.
(1) https://files.ssi.dk/Mink-cluster-5-short-report_AFO2
Graham Mullis, Group CEO of Novacyt, commented:
"Novacyt continues to innovate in its response to the rapidly
changing needs of the COVID-19 testing market. In particular, the
launch of PROmate(TM) is expected to further improve the workflow
efficiency of our near-patient testing system, enabling reduc ed
operator complexity and faster cycle times for our market leading
PCR COVID-19 test. Not only do t he additions to the portfolio
broaden the Company's ability to support clinicians and
laboratories through the pandemic, they also strengthen our
position in infectious disease diagnostics as we continue to
redefine our R&D pipeline for the next three years, in line
with our long-term growth strategy."
- 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 / Alex Shaw / 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
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