TIDMNCYT
RNS Number : 3778W
Novacyt S.A.
23 April 2021
Novacyt S.A.
("Novacyt", the "Company" or the "Group")
R&D and UK operational update
Paris, France and Camberley, UK - 23 April 2021 - Novacyt (
EURONEXT GROWTH: ALNOV; AIM: NCYT ), an international specialist in
clinical diagnostics, announces an update on the progress of its
near-term COVID-19 research and development (R&D) programmes to
address rapidly evolving testing demands, particularly as
SARS-CoV-2 continues to mutate around the world. Novacyt also
provides an update on its UK operations .
R&D highlights
-- Expansion of PathFlow(R) lateral flow test (LFT) portfolio with COVID-19 tests
o Launch of LFT to detect SARS-CoV-2 IgG antibodies
o Development of LFT to detect and differentiate between
SARS-CoV-2 IgG antibodies, launch expected Q3 2021
o Development of LFT to detect antigens for SARS-CoV-2, launch
expected by end of Q2 2021
-- Expansion of genesig (R) COVID-19 polymerase chain reaction (PCR) portfolio
o Launch of CE Mark three-gene target PCR test
-- Expansion of PROmate(TM) COVID-19 PCR portfolio for workflow
efficiency in a near-to-patient setting
o Development of two-gene target test, launch expected May
2021
o Launch of test to identify a key mutation, E484K, found in all
current variants of concern (VOC)
-- Expansion of SNPsig (R) COVID-19 PCR genotyping portfolio to detect SARS-CoV-2 variants
o Launch of CE Mark VariPLEX(TM) assay panel to detect multiple
variants
o Development of test to detect a variant originally identified
in India, launch expected week commencing 26 April 2021
UK operational highlights
-- Expansion of UK commercial infrastructure
-- Inclusion in Public Health England (PHE) National Framework Agreement
Graham Mullis, Chief Executive Officer of Novacyt,
commented:
"The continued development and expansion of our COVID-19
portfolio demonstrates Novacyt's ability to match the rapid
evolution of SARS-CoV-2 with real-time bioinformatics surveillance
and accelerated product development. We remain committed to
identifying patient needs and overcoming healthcare challenges
today and in the years ahead as we continue to strengthen our
position as a leading innovator in diagnostic testing.
"We are also pleased to be included in the PHE national
framework, which allows PHE and NHS hospitals to purchase our
accredited products without the need for direct contract awards. We
look forward to the opportunity to expand our support of diagnostic
testing in the UK through our established infrastructure and
building a long-term future in this important market, as well as in
international markets as we continue to invest in our direct
commercial operations."
Expansion of the PathFlow(R) LFT portfolio
PathFlow(R) SARS-CoV-2 IgG is a professional use LFT for the
detection of SARS-CoV-2 IgG antibodies, launched as a CE-IVD on 31
March 2021. The test provides a rapid turnaround time of results
from ten minutes and has demonstrated sensitivity of 98% and
specificity of 99% in validation studies.
PathFlow (R) SARS-CoV-2 SMART IgG is a next generation LFT to
detect and, importantly, differentiate between IgG antibodies. The
test is expected to assist clinicians in understanding the impact
of immunisation programmes, as well as the levels of immunity
derived from infection by the virus. The Company now expects to
launch this test as a CE-IVD in Q3 2021.
PathFlow (R) SARS-CoV-2 Antigen is a professional and home use
LFT for the detection of SARS-CoV-2 antigens using non-invasive
anterior nasal swab samples to provide a result in approximately 15
minutes. Novacyt has been working with a partner to develop this
test, which is able to detect the virus regardless of current known
mutations. The Company intends to launch the test as CE-IVD before
the end of Q2 2021 and expects it to complement Novacyt's
established position in COVID-19 PCR testing. As the market for
COVID-19 testing continues to develop, the Directors believe this
product could add significant revenues for Novacyt.
Expansion of the genesig (R) COVID-19 PCR portfolio
Following an emerging need in some countries, Novacyt has
launched a CE-IVD genesig (R) COVID-19 three-gene target test for
use with nasopharyngeal, oropharyngeal and saliva sample types.
This key extension to the genesig(R) COVID-19 portfolio, alongside
the one-gene and two-gene tests, is expected to be critical for use
in airport test and release programmes to and from certain
countries.
Expansion of the PROmate(TM) PCR portfolio
PROmate(TM) remains the only direct-to-PCR assay approved by the
UK's Technology Validation Group and enables near-to-patient
testing with results in under 90 minutes. The current CE-IVD
PROmate(TM) COVID-19 test identifies the SARS-CoV-2 ORF1ab gene.
Due to an emerging need in some countries, the Company expects to
launch a second CE-IVD PROmate(TM) COVID-19 test in May 2021 to
identify both the SARS-CoV-2 ORF1ab gene and M gene.
In addition, Novacyt has launched PROmate(TM) SARS-CoV-2 E484K,
a research-use-only (RUO) test to identify this key mutation, with
a CE-IVD planned subject to demand. E484K is a mutation found in
all current VOC and has been associated with immune evasion and
reduction of vaccine efficacy.
Expansion of the SNPsig(R) PCR genotyping portfolio
In addition to Novacyt's recently launched CE-IVD assay panel,
VariPLEX(TM), the Company has eight RUO assays, which it believes
is the most complete variant detection portfolio currently
available to address the globally prevalent variants of
SARS-CoV-2.
An RUO assay to detect a new variant originally identified in
India is expected to be launched in the next week and reinforces
Novacyt's leadership in responding to an urgent public health need
and market requirements. (Full detail on the SNPsig(R) portfolio
can be found below.)
UK operational update
Novacyt has invested significantly in supporting the UK market
during the past 12 months and now has over 50 field specialists
servicing the NHS across England, Wales, Scotland and Northern
Ireland. In addition, Primerdesign and Microgen Bioproducts,
Novacyt's wholly owned subsidiaries, have been included in the
National Microbiology Framework for Diagnostic Goods and Services
(Lot 1) published by PHE for a full range of clinical products,
including tests within the Company's accredited portfolio.
The successful inclusion of Primerdesign and Microgen
Bioproducts in the PHE National Framework Agreement, coupled with
the Company's investment in its commercial infrastructure to
deliver new products and establish a direct sales force, means
Novacyt is well positioned to develop a long-term commercial
position in the UK market.
- End -
Contacts
Novacyt SA
Graham Mullis, Chief Executive Officer
James McCarthy, 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 /
alex.shaw@fticonsulting.com / mary.whittow@fticonsulting.com /
Novacyt.group@fticonsulting.com
FTI Consulting (France)
Arnaud de Cheffontaines
+33 (0)147 03 69 48
arnaud.decheffontaines@fticonsulting.com
About the SNPsig(R) portfolio
The table below contains details on Novacyt's SNPsig (R)
portfolio of products, which have been launched to date or are due
to launch imminently. Novacyt's bioinformatics surveillance group
remains highly vigilant and, as significant new mutations are
identified, these will be added to the SNPsig (R) portfolio.
Assay Type Detection Profile
SNPsig(R) VariPLEX (TM) SARS-CoV-2 20I/501Y.V1, 20H/501Y.V2, 20J/501Y.V3,
20C/S.452R, N501Y, E484K
---------------------------------------
SNPsig(R) SARS-CoV-2 (20I/501Y.V1) 20I/501Y.V1 (UK)
---------------------------------------
SNPsig(R) SARS-CoV-2 (20H/501Y.V2) 20H/501Y.V2 (SA)
---------------------------------------
SNPsig(R) SARS-CoV-2 (20J/501Y.V3) 20J/501Y.V3 (Brazil)
---------------------------------------
SNPsig(R) SARS-CoV-2 (20B/S.484K) 20B/S.484K (Brazil)
---------------------------------------
SNPsig(R) SARS-CoV-2 (N501Y) Variants with the N501Y mutation
(UK, SA & Brazil)
---------------------------------------
SNPsig(R) SARS-CoV-2 (E484K) Variants with the E484K mutation
---------------------------------------
SNPsig(R) SARS-CoV-2 (L452R) Variants with the L452R mutation
---------------------------------------
SNPsig(R) SARS-CoV-2 (VUI-21APR-01) VUI-21APR-01 (India)
*
---------------------------------------
SNPsig(R) SARS-CoV-2 (VUI-21MAR-02) VUI-21MAR-02 (Brazil)
*
---------------------------------------
*in development
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 offers microbiology,
haematology and serology products with a focus in respiratory and
transplantation markets.
For more information please refer to the website:
www.novacyt.com
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