Novacyt S.A. ("Novacyt", the "Company" or the "Group"): Launch of CE-Mark test to detect multiple COVID-19 variants of concern
24 Marzo 2021 - 8:00AM
Business Wire
SNPsig® VariPLEX™ is able to detect six key
mutations of SARS-CoV-2 using PCR genotyping in under two
hours
Regulatory News:
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®
VariPLEX™ 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™ is the latest addition to Novacyt’s innovative and
expanding PCR genotyping assay portfolio, SNPsig®, to identify
mutations (single nucleotide polymorphisms (SNPs)). The VariPLEX™
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™ 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™ 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™ 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™, 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.”
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® portfolio
The table below contains details on Novacyt’s SNPsig® 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® portfolio.
Product names
Detection profile
Format
Product code
SNPsig® VariPLEX™ SARS-CoV-2#
20I/501Y.V1, 20H/501Y.V2, 20J/501Y.V3,
20C/S.452R, N501Y, E484K
CE-IVD,
RUO
D00060
R00137
SNPsig® SARS-CoV-2 PLUS (20I/501Y.V1)#
20I/501Y.V1 and E484K
CE-IVD
D00066
SNPsig® SARS-CoV-2 (20I/501Y.V1)
20I/501Y.V1
RUO
R00130
SNPsig® SARS-CoV-2 (20H/501Y.V2)
20H/501Y.V2
R00135
SNPsig® SARS-CoV-2 (20J/501Y.V3)
20J/501Y.V3
R00134
SNPsig® SARS-CoV-2 (20B/S.484K)*
20B/S.484K
R00147
SNPsig® SARS-CoV-2 (N501Y)
Variants with the N501Y mutation
(20I/501Y.V1, 20H/501Y.V2, 20J/501Y.V3)
R00131
SNPsig® SARS-CoV-2 (E484K)
Variants with the E484K mutation
(20I/501Y.V1, 20H/501Y.V2, 20J/501Y.V3, 20C/S.452R)
R00132
#Will be launched w/c 22 March 2021
*Will be launched w/c 29 March 2021
References:
- 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).
- 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).
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
- 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
- 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
- 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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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
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