TIDMNSCI
RNS Number : 5812L
NetScientific PLC
16 May 2022
NetScientific plc
( " NetScientific " , the "Group" or the "Company " )
ProAxsis Update
ProAxsis announces "impressive" results in performance
evaluation of the in-licensed AstraZeneca COVID-19 antibody
test
-- Successful completion of evaluation of the AstraZeneca COVID-19 antibody test
-- The assay showed exceptional levels of sensitivity and
specificity of 100% and 99.3% respectively
-- Successful development strengthens ProAxsis's expanding
product range and international customer offering
-- Additive to NetScientific's Trans-Atlantic plans
NetScientific plc (AIM: NSCI), the international life sciences
and sustainability technology investment and commercialisation
Group announces that its wholly owned subsidiary ProAxsis has
completed the development and validation of the AstraZeneca
COVID-19 antibody test with "impressive performance evaluation
results."
In June 2021 ProAxsis entered into an exclusive licensing
agreement with the global biopharmaceutical company AstraZeneca,
under which ProAxsis took responsibility for completing the
development, validation and global commercialisation of a
SARS-CoV-2 (the virus associated with COVID-19) serology ELISA
(enzyme-linked immunosorbent assay).
The detailed independent performance evaluation study by Prof.
Tara Moore of Ulster University, analysed over 1,100 clinical
serology samples. The assay was able to detect IgG antibodies in
blood samples from previously infected individuals, vaccinated
individuals, and also detected IgG from individuals known to be
infected by the different SARS-CoV-2 variants - Alpha, Delta and
Omicron. Furthermore, strong evidence of assay specificity for
SARS-CoV-2 antibodies was found when the assay was assessed against
over 100 serology from virus infections including common corona
virus, influenza virus and many other common respiratory
viruses.
The assay showed exceptional levels of sensitivity and
specificity of 100% and 99.3% respectively, and enabled the
SARS-CoV-2 antibodies to be measured and tracked over time in
individuals. The test uses a simple blood sample, and will be
launched into the research and clinical trials markets, which are a
core part of ProAxsis's business . This successful development
reinforces the standing of ProAxsis, and this test further
strengthens its expanding product range and international customer
offering.
Registration of the assay for a CE Mark has been formally
submitted.
John Clarkson, Chairman of NetScientific and ProAxsis
commented:
"The global AstraZeneca licence for this antibody test provides
a valuable addition to ProAxsis's respiratory diagnostics offerings
and expanded product range in a post-COVID-19 world. The clinical
trials market is a core part of ProAxsis's business, and this test
provides further commercial opportunities for ProAxsis. Over 3,500
COVID-19 related clinical trials are currently either recruiting or
in preparation around the World, involving approximately 1 million
subjects.
"The successful completion of this high-profile exercise marks
another significant milestone in the implementation of ProAxsis'
growth strategy. After signing the global licence agreement with
AstraZeneca, it has been a period of hard work, with rigorous
testing, development and validation by the highly skilled ProAxsis
team, complemented by the excellent work of Professor Tara Moore.
By any standards, this is an excellent result. This highly
sensitive and specific test provides a significant enhancement to
the company's commercial offering; further extending product range
and reinforcing the continued international expansion. This fits
well with NetScientific's Trans-Atlantic bridges and global
strategic plans."
Prof. Smith, NetScientific PLC Non-Executive Director, said : "
COVID-19 restrictions are generally lifting around the world, but
the virus has not gone away. Whilst Omicron was a milder variant,
future strains may be more virulent. We are learning to live with
the reality that COVID will be with us for some time, with
potentially serious consequences for elderly and vulnerable people.
This test's accuracy and ability to detect multiple assay variants
makes it an especially valuable tool for vital research, supporting
ongoing and future pandemic response strategies and the
individual.
"The serology ELISA developed by ProAxsis is impressively able
to detect the various strands and mutations of the SARS-CoV-2
virus. It is excellent news that we can play our part and help
deliver real benefits to the community, through the application of
ProAxsis' expertise in respiratory assays. "
NetScientific holds 100% of the issued shares and 95% of
ProAxsis on a fully diluted basis.
The full text of the announcement from ProAxsis Limited is
reproduced below and is available online here:
(https://proaxsis.com).
###
ProAxsis announces "impressive" results in Performance
Evaluation of COVID-19 antibody test
Date: May 16, 2022
ProAxsis Limited ( www.proaxsis.com ), the Belfast-based
respiratory diagnostics company, has successfully completed the
Performance Evaluation study of the COVID-19 antibody test,
initially created by AstraZeneca, with impressive results.
The assay has exceptional levels of sensitivity and specificity
of 100% and 99.3% respectively, and enables the SARS-CoV-2
antibodies to be measured and tracked over time in individuals.
This assay requires a simple blood sample and will be launched into
the research and clinical trials markets, further strengthening
ProAxsis's expanding product range and international customer
offering.
ProAxsis previously announced that it had entered into an
exclusive licensing agreement with the global biopharmaceutical
company AstraZeneca for the Worldwide commercialisation rights of a
SARS-CoV-2 (the virus associated with COVID-19) serology
Enzyme-Linked ImmunoSorbent Assay (ELISA) that detects antibodies
to SARS-CoV-2. The highly skilled ProAxsis team have further
developed and validated this valuable assay, which in addition has
been rigorously tested by Professor Tara Moore, a leading expert in
this field.
Hence, ProAxsis is now delighted to confirm that the necessary
work for CE Marking has been completed and as such, a notification
has been sent to the MHRA. The company expects acknowledgment of
receipt from the MHRA shortly, which is a prerequisite of market
launch.
In return for providing access to the required intellectual
property and technical know-how, AstraZeneca will receive an
undisclosed royalty fee on future Global net sales of the
assay.
Speaking about the news, Professor Tara Moore, Professor of
Precision Medicine at Ulster University, commented:
"This assay performed exceptionally well in the Performance
Evaluation study which analysed >1100 clinical serology samples
demonstrating levels of sensitivity and specificity of 100% and
99.3% respectively, which was extremely impressive. The assay was
able to detect IgG antibodies in blood samples from previously
infected individuals, vaccinated individuals and also detected IgG
from individuals known to be infected by the different SARS-CoV-2
variants - Alpha, Delta and Omicron. Furthermore, strong evidence
of assay specificity for SARS-CoV-2 antibodies was found when the
assay was assessed against over 100 serology from virus infections
including common corona virus, influenza virus and many other
common respiratory viruses. The full data set will be published in
a peer reviewed journal at the earliest opportunity."
Ruth March, SVP, Precision Medicine, AstraZeneca, added:
"The development of this serology ELISA by our team is another
example of AstraZeneca's comprehensive response to the COVID-19
pandemic. We are delighted to see the formal validation of the
assay and the results of the independent Performance Evaluation
study that has formed a critical part of the submission for
registration of the assay with a CE Mark."
Dr David Ribeiro, CEO of ProAxsis , said:
"This is clearly great news for both ProAxsis and AstraZeneca.
The initial work conducted by AstraZeneca provided a strong
framework for our team to further develop, optimise and validate
the antibody assay. A critical component of the validation process
was the completion of an external independent Performance
Evaluation study, and we greatly appreciate the efforts of
Professor Tara Moore to complete this work in a timely and highly
professional manner."
Any enquiries concerning the new SARS-CoV-2 serology assay can
be directed to info@proaxsis.com.
About ProAxsis
ProAxsis Limited is a commercial diagnostics company, based in
Northern Ireland, and with a rapidly growing global client list of
pharmaceutical companies and academic laboratories. The company has
already CE Marked their activity-based immunoassays targeting
Neutrophil Elastase (NE) and Proteinase 3, as biomarkers of lung
infection and inflammation in chronic respiratory diseases such as
COPD, cystic fibrosis and bronchiectasis.
This technology has been translated into a point-of-care test
(NEATstik(R)), to enable ongoing monitoring of active NE levels.
Recently published data has shown that measuring active NE levels
using NEATstik(R) enables identification of patients with airway
bacterial infection and those patients at highest risk of suffering
pulmonary exacerbations over the subsequent 12 months.
In addition to proteases, the company also has significant
expertise in the measurement of other inflammatory biomarkers,
including IL-6, IL-8 and TNF-alpha. Grant-funded R&D funded
projects for a variety of targets remain a key area of focus.
Aside from the provision of assays, ProAxsis can offer sample
analysis at its purpose-built laboratory facility in Belfast and is
currently supporting a number of pharmaceutical company-sponsored
Phase I, II and III clinical trials.
ProAxsis is a wholly owned subsidiary of NetScientific Plc.
# # #
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014. Following the
publication of this announcement, this inside information is now
considered to be in the public domain.
For more information, please contact:
NetScientific Via Walbrook PR
John Clarkson, Chairman
WH Ireland (NOMAD, Financial Adviser
and Broker)
Chris Fielding / Darshan Patel +44 (0)20 7220 1666
Walbrook PR
Nick Rome/ Paul McManus 07748 325 236 or 07980 541 893
About NetScientific
NetScientific plc (AIM: NSCI) is an active holding company, that
invests in, develops, commercialises and realises shareholder value
in life sciences/healthcare, sustainability and technology
companies, which offer significant growth potential in the UK,
Europe and USA, as well as globally.
The Group has nearly trebled its portfolio from 8 to 22
companies, either through direct subsidiary, balance sheet
investment or capital under advisory, varying from start-up private
companies to publicly listed equities.
NetScientific delivers shareholder returns through a proactive
and hands-on management approach to their portfolio companies;
identifying, investing in, and helping to build game-changing
companies. The Group targets value inflection points and the
release of value through partial or full exits from trade sales,
public listings, or equity sales. The Company has a strong
transatlantic and growing international presence, providing
attractive expansion prospects.
NSCI can deploy a capital-light investment structure; utilising
the power of the PLC Brand, and the NetScientific balance sheet to
anchor future investments and achieve a multiplier effect by
attracting 3rd party investment for the portfolio companies.
NetScientific is headquartered in London, United Kingdom, and
was admitted to trading on AIM, a market operated by the London
Stock Exchange, in 2013 (website: www.netscientific.net).
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