Significant new opportunities for
growth
Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international
specialist in clinical diagnostics, announces an R&D
update.
R&D highlights
- Launch of near-patient (mobile) testing, which comprises
Novacyt’s COVID-19 test, direct-to-PCR RNA extraction kit (Exsig™
Direct), and q16 and q32 instruments
- Launch of a saliva sampling type to support ease of patient
sampling, lower levels of discomfort and demonstrate more
reproducible data
- Development of a respiratory testing panel to diagnose and
distinguish between influenza A&B, RSV and COVID-19. Launch
expected during September 2020 for the 2020/21 flu season in the
Northern hemisphere
- Development of a two-gene test to address markets employing
this testing approach. Launch expected no later than September
2020
- Development, together with a partner, of a serology (antibody)
test to detect past infection of COVID-19. Launch expected in Q4
2020
The Company’s COVID-19 polymerase chain reaction (PCR) test was
one of the first to be developed and registered under the CE-IVD
Directive, establishing Novacyt as a pioneer and a leader in
COVID-19 diagnostics. The success of the product has been built
around robust design principles and the selection of a gene target
that has so far demonstrated exceedingly low levels of genetic
mutation and variation. To date, the target has been analysed
against 42,655 individual COVID-19 viral sequences and demonstrated
100% detection.
Novacyt remains committed to building on this innovative
position for COVID-19 testing, and more broadly for respiratory
disease testing, and investing to address unmet needs in the
market. The Company has already launched three new innovative
products, Exsig™ Direct, Exsig™ Mag and COVID-HT, to support
laboratories testing for COVID-19 through improving workflow
efficiency and helping to address the reported shortfall in global
manufacturing and supply of extraction reagents.
Scientists at the Company continue to innovate and detailed
below is an update on the current development activities, which are
expected to drive incremental revenue for the Company once
launched. Novacyt continues to build on its patent portfolio
through new filings to protect its products and market leading
position in COVID-19 testing.
Launch of near-patient (mobile) testing
Further to the Company announcement on 22 July 2020, Novacyt
confirms the launch of its near-patient testing (NPT) system for
COVID-19. Validation of the NPT system includes analysis of over
400 patient samples carried out by a leading, accredited clinical
laboratory. The reported sensitivity and specificity are both
greater than 99%.
A number of NHS hospitals are already using Novacyt’s NPT system
in hospital departments. Pilot programmes are underway in surgical,
cancer and imaging departments where rapid, accurate testing is a
pre-requisite to the patient receiving care. In addition, the NPT
system is being used in the private sector, such as professional
sport and mining industries. The Company is currently evaluating
other markets where the NPT system could be used for rapid and
frequent COVID-19 testing.
Launch of new sample type
The Company’s COVID-19 test was developed for use with sample
types initially preferred by testing authorities and key opinion
leaders, which include oropharyngeal (throat) and nasopharyngeal
(nasal) swabs, and sputum. To support ease of patient sampling,
lower levels of discomfort and demonstrate more reproducible data,
other less invasive and easier to collect sample types have been
discussed by various authorities.
Recent studies1 have demonstrated that saliva often has far
higher numbers of viral particles compared with nasopharyngeal
swabs. An independent study carried out by the Liverpool School of
Hygiene and Tropical Medicine using Novacyt’s COVID-19 test
concluded that “SARS-Cov-2 can be detected with greater sensitivity
in saliva samples compared to nasal swabs” 2. Further to completing
its own validation of the saliva sampling type, Novacyt confirms
this sample type can be used with its COVID-19 test.
In addition, as detailed in the Company’s announcement on 22
July 2020, a 2,000 patient clinical trial led Queen Mary University
of London using Novacyt's near-patient testing system, is
evaluating the effectiveness of mid-nose nasal swabs compared to
invasive nasopharyngeal swabs as a further sampling type.
Development of a respiratory testing panel
There remains a challenge for healthcare providers in
differentiating COVID-19 from other respiratory diseases,
particularly during a seasonal flu outbreak, due to patients
presenting with similar symptoms. This is driving the requirement
for the development of respiratory testing panels that are able to
diagnose and distinguish the difference between types of flu and
COVID-19. Novacyt has been working closely with certain key opinion
leaders to determine the make-up of such panels. This has resulted
in the development of a panel covering the differential diagnosis
of influenza A&B, respiratory syncytial virus (RSV) and
COVID-19. Novacyt expects to launch the panel as a CE Mark product
in September 2020 for the 2020/21 “flu season” in the Northern
hemisphere.
Development of a two gene test
Whilst the Company’s COVID-19 test continues to demonstrate a
market leading performance in terms of specificity and sensitivity,
there are a number of countries legislating that a two-gene testing
approach is employed. This approach is driven by concerns regarding
mutation of the virus and the inability for some other PCR tests to
detect positive cases.
Whilst Novacyt is able to demonstrate the superiority of its
specific single gene approach, with the test having received
emergency use authorisation from most major health bodies,
including the US FDA and WHO, the insistence on deployment of two
gene tests has impaired the Company’s ability to penetrate certain
markets. The Company is therefore finalising the development of its
own two gene target test and expects to launch this two gene test
no later than September 2020.
Serology (antibody) testing
It has been widely documented that healthcare providers require
an effective method to identify individuals who have previously
been exposed to COVID-19 and who may therefore have immunity to
further infection. Serological methods typically try to distinguish
between IgM and IgG antibodies.
The human immune response to infection results in the body
producing different types of antibodies at different stages of the
infection, with IgM being produced before IgG. However, the initial
antibody response is not produced immediately and may not be
detectable until up to 14 days after infection. Therefore,
detection of viral RNA by PCR testing is the most sensitive method
of choice in early diagnosis of infection, often in patients who
are showing few or no clinical symptoms. The IgM antibody response
is also short lived. However, the body generates a longer lasting
response with the production of IgG antibodies. It is these IgG
antibodies that are indicative of past infection and which can
typically impart some form of immunity against future
infection.
Following extensive investigation of a number of serological
methods, Novacyt is working with a partner who has developed a test
for the detection of the IgG antibody to COVID-19. To date, the
product has demonstrated significant levels of sensitivity and
specificity for detection of IgG in patients 14 days after testing
positive for COVID-19 by a PCR test. Novacyt is now in the process
of conducting its own performance evaluation to validate the
serology test and will look to launch a CE Mark product during the
fourth quarter of 2020.
Graham Mullis, Group CEO of Novacyt, commented:
“Novacyt has established itself as a pioneer in COVID-19
diagnostics through the rapid development and success of its PCR
test for the virus. We remain committed to building on this
innovative position for COVID-19 testing, and more broadly across
infectious diseases, as we continue to invest in the business to
address unmet needs in the diagnostics market. The immediate
pipeline of new products is expected to drive incremental revenue
for the Company in the near-term, but Novacyt’s strengthened
financial position also means we are able to redefine our R&D
pipeline for the next three years, which we expect to drive
significant and continued growth opportunities in the
longer-term.”
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
1 Wyllie et al: medRxiv 2020.04.16.20067835; doi:
https://doi.org/10.1101/2020.04.16.20067835 2 Byrne and Adams et
al: medRxiv preprint doi:
https://doi.org/10.1101/2020.07.09.20149534; July 2020
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version on businesswire.com: https://www.businesswire.com/news/home/20200726005029/en/
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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