TIDMNCYT
RNS Number : 2590T
Novacyt S.A.
24 March 2021
Novacyt S.A.
("Novacyt", the "Company" or the "Group")
Launch of CE-Mark test to detect multiple COVID-19 variants of
concern
SNPsig(R) VariPLEX(TM) is able to detect six key mutations of
SARS-CoV-2 using PCR genotyping in under two hours
Paris, France and Camberley, UK - 24 March 2021 - Novacyt
(EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in
clinical diagnostics, announces that, further to the announcement
on 2 February 2021, the Company will launch SNPsig(R) VariPLEX(TM)
this week as a CE-Mark approved polymerase chain reaction (PCR)
assay panel able to detect the four COVID-19 variants of concern
(VOC) that are currently recognised and the two most biologically
significant mutations in a single kit.
VariPLEX(TM) is the latest addition to Novacyt's innovative and
expanding PCR genotyping assay portfolio, SNPsig(R) , to identify
mutations (single nucleotide polymorphisms (SNPs)). The
VariPLEX(TM) panel detects the variants originally identified in
the UK (20I/501Y.V1), South Africa (20H/501Y.V2), Brazil
(20J/501Y.V3) and California (20C/S.452R), and mutations N501Y and
E484K, which are now all prevalent globally.(1)
VariPLEX(TM) can be deployed on-site in near-patient settings to
generate results in under two hours to facilitate same-day patient
and public health decision making when using the Company's q32
instruments or in any central laboratory with an open platform
instrument with the ability to detect across at least four
fluorescent channels. This provides a rapid alternative or could
complement next generation sequencing, which typically requires up
to 14 days of off-site analysis.
At present, if SARS-CoV-2 variants are considered to have
'concerning' properties, including causing higher infection rate,
reduced vaccine efficacy or resistance to antibody treatment, they
are raised for formal investigation and classified as a variant
under investigation (VUI).(2) Following a risk assessment with the
relevant expert committee, such as the World Health Organization, a
VUI may be designated as a VOC. Due to the concerning properties,
Novacyt recognises the importance and need to closely monitor VOC
and significant mutations. Therefore, VariPLEX(TM) is a fully
customisable assay panel and new mutations can be added to the
panel within weeks as and when they become relevant.
Concurrently, Novacyt is also making a research use only (RUO)
version of VariPLEX(TM) available for epidemiological application
and will be pursuing emergency use authorisations in a number of
countries.
Graham Mullis, Chief Executive Officer of Novacyt,
commented:
"This is an important step in our response to COVID-19. As we
reach a point where vaccination efforts are increasing globally, we
are also seeing a worrying rise in the number of variants of the
virus, all of which bring subtly different challenges to healthcare
systems around the world. With VariPLEX(TM), we are offering an
affordable, scalable and time efficient alternative to next
generation sequencing which allows for reliable testing of key
variants in a single test. By providing an on-site solution which
reads out in less than two hours, we are ensuring that it is
possible to track variants and the infections they cause on a
global scale."
- 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 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
About N501Y and E484K mutations
The N501Y mutation is important as it leads to an increase in
ACE2 binding and therefore to increased infectivity.(3) This
mutation has been seen in the UK, South African, and Brazilian
variants and has been correlated in epidemiological studies to
increase infectivity by approximately 70% and could potentially
lead to an increase in mortality.(4-8) The E484K mutation is seen
in all current VOC and is called an escape mutation because it
helps the virus slip past the body's immune defences to evade host
antibodies and may, as a result, diminish the efficacy of
immunisation.(4-7,9-12)
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.
Product names Detection profile Format Product
code
SNPsig(R) VariPLEX(TM) 20I/501Y.V1, 20H/501Y.V2, CE-IVD, D00060
SARS-CoV-2 (#) 20J/501Y.V3, 20C/S.452R, RUO
N501Y, E484K
--------------------------- -------- --------
R00137
--------------------------- -------- --------
SNPsig (R) SARS-CoV-2 20I/501Y.V1 and E484K CE-IVD D00066
PLUS (20I/501Y.V1) (#)
--------------------------- -------- --------
SNPsig(R) SARS-CoV-2 20I/501Y.V1 R00130
(20I/501Y.V1)
--------------------------- -------- --------
SNPsig(R) SARS-CoV-2 20H/501Y.V2 R00135
(20H/501Y.V2)
--------------------------- --------
SNPsig(R) SARS-CoV-2 20J/501Y.V3 R00134
(20J/501Y.V3)
--------------------------- --------
SNPsig(R) SARS-CoV-2 20B/S.484K R00147
(20B/S.484K)(*)
--------------------------- --------
SNPsig(R) SARS-CoV-2 Variants with the N501Y R00131
(N501Y) mutation (20I/501Y.V1,
20H/501Y.V2, 20J/501Y.V3)
--------------------------- --------
SNPsig(R) SARS-CoV-2 Variants with the E484K R00132
(E484K) mutation (20I/501Y.V1,
20H/501Y.V2, 20J/501Y.V3,
20C/S.452R) RUO
--------------------------- -------- --------
(#) Will be launched w/c 22 March 2021
(*) Will be launched w/c 29 March 2021
References:
1. World Health Organization. COVID-19 Weekly Epidemiological
Update. World Health Organization 1-3. Available from:
https://www.who.int/publications/m/item/weekly-epidemiological-update---16-march-2021
(2021).
2. World Health Organization. Weekly epidemiological update - 25
February 2021. World Health Organization 1-3 Available from:
https://www.who.int/publications/m/item/covid-19-weekly-epidemiological-update
(2021).
3. Starr TN, Greaney AJ, Hilton SK, Ellis D, Crawford KHD,
Dingens AS, et al. Deep Mutational Scanning of SARS-CoV-2 Receptor
Binding Domain Reveals Constraints on Folding and ACE2 Binding.
Cell [Internet]. 2020;182(5):1295-1310.e20. Available from:
http://dx.doi.org/10.1016/j.cell.2020.08.012
4. Wang Z, Schmidt F, Weisblum Y, Muecksch F, Finkin S,
Schaefer-Babajew D, et al. mRNA vaccine-elicited antibodies to
SARS-CoV-2 and circulating variants 2 3. bioRxiv [Internet]. 2021
[cited 2021 Jan 25]; Available from:
https://doi.org/10.1101/2021.01.15.426911
5. Novavax Inc. - IR Site. Novavax COVID-19 Vaccine Demonstrates
89.3% Efficacy in UK Phase 3 Trial [Internet]. [cited 2021 Feb 1].
Available from:
https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3
6. Johnson | Johnson & Johnson. Johnson & Johnson
Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met
Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
[Internet]. [cited 2021 Feb 1]. Available from:
https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial
7. Andreano E, Piccini G, Licastro D, Casalino L, Johnson N V,
Paciello I, et al. SARS-CoV-2 escape in vitro from a highly
neutralizing COVID-19 convalescent plasma. bioRxiv [Internet].
2020;2020.12.28.424451. Available from:
http://biorxiv.org/content/early/2020/12/28/2020.12.28.424451.abstract
8. Horby, A. P. et al. NERVTAG - Presented to SAGE on 21/1/21. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/
961037/NERVTAG_note_on_B.1.1.7_severity_for_SAGE_77__1_.pdf
(2021)
9. Greaney AJ, Loes AN, Crawford KH, Starr TN, Malone KD, Chu
HY, et al. Comprehensive mapping of mutations to the SARS-CoV-2
receptor-binding domain that affect recognition by polyclonal human
serum antibodies. [cited 2021 Jan 19]; Available from:
https://doi.org/10.1101/2020.12.31.425021
10. Cele S, Gazy I, Jackson L, Hwa S-H, Tegally H, Lustig G, et
al. Escape of SARS-CoV-2 501Y.V2 variants from neutralization by
convalescent plasma. medRxiv [Internet]. 2021 [cited 2021 Jan
25];1-19. Available from:
https://www.medrxiv.org/content/10.1101/2021.01.26.21250224v1
11. COG-UK. COG-UK report on SARS-CoV-2 Spike mutations of
interest in the UK [Internet]. Vol. 1. 2021. Available from:
https://cov-lineages.org/global_report.html
12. Wu K, Werner AP, Moliva JI, Koch M, Choi A, Stewart-Jones
GBE, et al. mRNA-1273 vaccine induces neutralizing antibodies
against spike mutants from global SARS-CoV-2 variants. bioRxiv
[Internet]. 2021 [cited 2021 Jan 29]; Available from:
https://doi.org/10.1101/2021.01.25.427948
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