Novacyt S.A.: Launch of PCR Genotyping Assay Portfolio to Detect COVID-19 Variants
02 Febbraio 2021 - 8:00AM
Business Wire
Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt", the
"Company" or the “Group”), an international specialist in clinical
diagnostics, announces the launch of a new and innovative portfolio
of assays (under the brand name SNPsig®) to aid the diagnosis of
the new variants of SARS-CoV-2.
Novacyt’s existing polymerase chain reaction (PCR) COVID-19
portfolio remains highly accurate in detecting all published
SARS-CoV-2 variants. The launch of the new SNPsig® portfolio
complements and expands the Company’s offering into the rapidly
evolving requirement for PCR genotyping of variants.
As noted by the US Centers for Disease Control and Prevention,
multiple SARS-CoV-2 variants emerged in late 2020. The three most
notable variants were originally identified by their reporting
origin, the UK (20I/501Y.V1 or B.1.1.7), South Africa (20H/501Y.V2
or B.1.351) and Brazil (20J/501Y.V3 or B.1.1.28) but are now
prevalent globally1. The emergence of these variants has been
reported across Europe, in 32 US states2, Japan, Africa and Latin
America and is expected to significantly impact the clinical care
of individual patients, local community disease control and
national epidemiological strategies3, due to suggested evidence
that these variants are associated with an increase in mortality
and transmission4.
The tracking of variants could also contribute to the
effectiveness of vaccination efforts, especially if, as described
in recent publications, the emergence of variants may have an
impact on vaccine efficaciousness5. The SNPsig® assays offer the
ability to track variants on-site and to generate a result in
hours, compared to the current approach of next generation
sequencing, which is typically constrained by limited capacity,
cost and an off-site multi-day turnaround.
Novacyt’s bioinformatics surveillance group has worked with a
global network of virologists tracking variants to identify the
mutations, or Single Nucleotide Polymorphisms (SNPs), critical to each variant.
From this analysis, Novacyt has developed and patented the SNPsig®
portfolio, which is one of the first commercially available for
variant detection. The first three SNPsig® assays, launched today,
enable the identification of the non-variant virus and the UK,
South Africa or Brazil variants, as well as any variant carrying
the N501Y mutation.
The next product in the SNPsig® portfolio, planned to launch
shortly, will be an assay panel, known as VariPLEX™, to detect
these three variants and two other key mutations identified by the
World Health Organization6 in a single test. Novacyt’s
bioinformatics surveillance group remains highly vigilant and, as
significant new mutations are identified, these will be added to
the SNPsig® portfolio.
The SNPsig® assays are designed to run on central laboratory
systems and on the Company’s q16 and q32 rapid PCR systems as
research-use-only products. The Company expects to launch the
regulatory approved clinical diagnostic assays next month.
Of note, the first three SNPsig® assays are also being deployed
to an international consortium of leading academic and public
health laboratories in the UK, Europe, US and Latin America7,
assembled by Novacyt to support a global variant diagnostic
surveillance study.
Graham Mullis, Chief Executive Officer of Novacyt,
commented: “It is clear that we must stay highly vigilant as
SARS-CoV-2 continues to mutate and may, therefore, remain as a
global threat for many years. Diagnostic companies have a key role
to play in aiding the clinical diagnosis of the variants of
greatest concern. We are therefore pleased to announce the rapid
development and launch of this portfolio of PCR genotyping assays
for the identification of specific new SARS-CoV-2 variants. With
this launch, Novacyt continues to demonstrate its ability to remain
at the forefront of this rapidly evolving field, with
market-leading intelligence and expertise that allows us to support
scientists and clinicians around the world in the fight against
this pandemic.”
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
____________________ 1
https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html
2
https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html
3
https://www.ecdc.europa.eu/sites/default/files/documents/COVID-19-risk-related-to-spread-of-new-SARS-CoV-2-variants-EU-EEA.pdf
4 NERVTAG paper on COVID-19 variant of concern B.1.1.7
(publishing.service.gov.uk) 5
https://jamanetwork.com/journals/jama/fullarticle/2776039 6
https://www.who.int/csr/don/21-december-2020-sars-cov2-variant-united-kingdom/en/
7 UK: University of B’ham, Cambridge, Edinburgh and QMUL, Europe:
Gibraltar; USA: Oklahoma, Texas; Latin America: Mexico, Colombia
and / or Dominican Republic
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Novacyt SA Graham Mullis, Chief Executive Officer James
McCarthy, Chief Financial Officer +44 (0)1276 600081
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