Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international
specialist in clinical diagnostics, announces that the Company’s
SNPsig® SARS-CoV-2 polymerase chain reaction (PCR) genotyping
portfolio has been included in the NHS England Framework for
detecting Variants of Concern (VoC). Novacyt also announces the
launch of two new PCR assays to detect SARS-CoV-2 VoC.
- Detecting known VoC Framework, announced by NHS England
on 14 May 2021, includes the Company’s SNPsig® SARS-CoV-2 PCR
genotyping portfolio as one of the four companies selected by NHS
England. This national framework is for testing of all positive
SARS-CoV-2 samples from NHS (pillar 1) and high throughput
Lighthouse (pillar 2) laboratories in England.
- SNPsig® COVID-19 (20I/501Y.V1 + E484K) is a CE Marked
assay to detect 20I/501Y.V1, the VoC originally identified in the
UK, VOC-21FEB-02 and all SARS-CoV-2 variants carrying the E484K
escape mutation.
- SNPsig® SARS-CoV-2 (E484K) Easy is a research-use-only,
streamlined workflow solution for the detection of SARS-CoV-2
variants carrying the E484K escape mutation for use with the
Company’s q32 rapid-PCR instrument. This assay comes with
pre-filled cassettes and includes only one pipetting step to
decrease operator complexity and improve cycle times.
Graham Mullis, Chief Executive Officer of Novacyt,
commented:
“We are very pleased to be included in NHS England’s VoC
Framework, which allows our SNPsig® range of products to be used at
any NHS and Lighthouse laboratories, subject to local verification,
as we continue to support diagnostic testing across the UK, and
globally, through our extensive portfolio. We remain committed to
developing new tests to match the rapid evolution of the SARS-CoV-2
virus with our real-time bioinformatics surveillance programme and
accelerated product development. Our SNPsig® portfolio for
detecting Variants of Interest and Variants of Concern now includes
12 individual assays to support scientists and clinicians in the
ongoing fight against COVID-19.”
About the E484K mutation
The E484K mutation has appeared independently in several VoC,
indicating an evolutionary advantage for SARS-CoV-2[1]. Multiple
studies have shown an association with reduced antibody
neutralisation in both natural and vaccine-elicited human sera2-4.
Early detection of the E484K mutation is critical to ensure a rapid
public health response.
About SNPsig® COVID-19 (20I/501Y.V1 + E484K)
The subpopulation of 20I/501Y.V1 carrying the E484K mutation was
first detected in the Southwest of England and was first known as
the Bristol Variant. This VoC, now named as VOC-21FEB-02, has been
detected predominantly in the UK. In addition to the observed
increase in transmissibility detected for 20I/501Y.V1, the E484K
mutation provides this VoC with potential for antibody escape.
SNPsig® COVID-19 (20I/501Y.V1 + E484K) is a product that combines
the detection of both the VoC 20I/501Y.V1 and the clinically
significant mutation E484K, allowing the identification of not only
20I/501Y.V1 and VOC-21FEB-02 positive cases, but also the presence
of E484K in one assay.
About SNPsig® SARS-CoV-2 (E484K) Easy
SNPsig® SARS-CoV-2 (E484K) Easy is a rapid direct solution based
on the Company’s simplified PROmate workflow, to detect the E484K
mutation in SARS-CoV-2 variants in less than 90 minutes using the
Company’s q32 instrument.
About the SNPsig® portfolio
Novacyt's bioinformatics surveillance group remains highly
vigilant and, as new biologically significant mutations are
identified, these will continue to be added to the SNPsig®
portfolio. A recent study reported in the medRxiv5, the preprint
server for health sciences, demonstrates the high potential of the
SNPsig® portfolio to detect the most significant mutations, VoCs
and variants. The portfolio is described below:
SNPsig® Assays launched
Assay Type
Detection Profile
SNPsig® SARS-CoV-2 (20I/501Y.V1)
RUO
20I/501Y.V1 (UK)
SNPsig® SARS-CoV-2 (20H/501Y.V2)
20H/501Y.V2 (SA)
SNPsig® SARS-CoV-2 (N501Y)
Variants with the N501Y mutation (UK, SA
& Brazil)
SNPsig® SARS-CoV-2 (E484K)
Variants with the E484K mutation
SNPsig® SARS-CoV-2 (20J/501Y.V3)
20J/501Y.V3 (Brazil)
SNPsig® VariPLEX (COVID-19)
CE-IVD
Variants originally identified in the UK
(20I/501Y.V1), South Africa (20H/501Y.V2), Brazil (20J/501Y.V3) and
California (20C/S:452R), and the key biologically significant
mutations N501Y and E484K
SNPsig® VariPLEX (SARS-CoV-2)
RUO
SNPsig® SARS-CoV-2 (20B/S.484K)
RUO
20B/S.484K (Brazil)
SNPsig® SARS-CoV-2 (L452R)
RUO
Variants with the L452R mutation
SNPsig® COVID-19 (20I/501Y.V1+ E484K)
CE-IVD
20I/501Y.V1, VOC-21FEB-02 and variants
carrying the E484K mutation
SNPsig® SARS-CoV-2 (E484K) Easy
RUO
Variants with the E484K mutation (one-step
PROmate workflow)
SNPsig® SARS-CoV-2 (VUI-21APR)
VUI-21APR-01 and VUI- 21APR-03 (India)
SNPsig® Assays in development
Assay Type
Detection Profile
SNPsig® EscapePLEX (SARS-CoV-2)
RUO
Variants with the E484K, K417N/T and P681R
mutations including the India, SA and BR VOCs
SNPsig® SARS-CoV-2 (VUI-21MAR-02)
VUI-21MAR-02 (Brazil)
SNPsig® SARS-CoV-2 (B.1.1.519)
B.1.1.519 (Mexico)
End
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
References
- Aline P, Ferrareze G, Bonetti Franceschi V, de Menezes Mayer A,
Caldana GD, Zimerman RA, Thompson CE E484K as an innovative
phylogenetic event for viral evolution: Genomic analysis of the
E484K spike mutation in SARS-CoV-2 lineages from Brazil. bioRxiv
[internet]. 2021; Available from:
https://doi.org/10.1101/2021.01.27.426895
- 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. bioRxiv [Internet]. 2021;
Available from: https://doi.org/10.1101/2021.01.15.426911
- Wang WB, Liang Y, Jin YQ, Zhang J, Su JG, Li QM. E484K mutation
in SARS-CoV-2 RBD enhances binding affinity with hACE2 but reduces
interactions with neutralizing antibodies and nanobodies: Binding
free energy calculation studies. bioRxiv [internet]. 2021;
Available from: https://doi.org/10.1101/2021.02.17.431566
- Jangra S, Ye C, Rathnasinghe R, Stadlbauer D, PVI Study Groupl,
Krammer F. The E484K mutation in the SARS-CoV-2 spike protein
reduces but does not abolish neutralizing activity of human
convalescent and post-vaccination sera. 2021. medRxiv [internet].
Available from: https://doi.org/10.1101/2021.01.26.21250543
- Daryl Borley, R.A. Trevor, Alex Richter, Stephen Kidd, Nick
Cortes, Nathan Moore, Alice Goring, Kate Templeton, Prachi
Teltumbde, Seden Grippon, Paul Oladimeji, Aida Sanchez-Bretano,
Andrew Dawson, Joanne E Martin. A prospective diagnostic study to
measure the accuracy of detection of SARS-CoV-2 Variants Of Concern
utilising a novel RT-PCR GENotyping algorithm in an In silico
Evaluation (VOC-GENIE) medRxiv 2021.05.05.21256396; doi:
https://doi.org/10.1101/2021.05.05.21256396
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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 / George Kendrick +44 (0)20 3727 1000
victoria.fostermitchell@fticonsulting.com /
Alex.Shaw@fticonsulting.com/ George.Kendrick@fticonsulting.com
FTI Consulting (France) Arnaud de Cheffontaines +33
(0)147 03 69 48 arnaud.decheffontaines@fticonsulting.com
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