Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international
specialist in clinical diagnostics, announces an update on the
progress of its near-term research and development programmes,
including the expansion of its product portfolio, clinical trial
activity and the publication of independent validations of the
Company’s COVID-19 tests.
In parallel with the current focus of continuing to maximize the
opportunity for COVID-19 testing, the Company is also continuing to
build on its strategy for delivering a sustainable, long-term
diagnostics business. Novacyt intends to present these plans during
Q2 2021.
The expansion of the Company’s COVID-19 portfolio continues to
address the rapidly evolving diagnostics market:
- Expansion of the SNPsig® portfolio to detect new SARS-CoV-2
variants of concern, including a specific variant prevalent in the
US
- Launch of CE Mark COVID-HT Direct, a next generation
direct-to-PCR SARS-CoV-2 test for high-throughput laboratories
- Development of the COVID-19 antibody lateral flow test
- Development of the loop-mediated isothermal amplification
COVID-19 test
- Development of an innovative assay panel for the detection of
aspergillus, a respiratory fungal infection associated with
co-infection risk in patients with COVID-19
- Development of a two-gene target PROmate™ test to address
markets employing this testing approach
The Company continues to support clinical research teams
undertaking clinical trials in the global COVID-19 testing
market:
- Queen Mary University of London has successfully completed the
clinical trial of rapid testing in care homes using the Company’s
rapid PCR system
- The variant diagnostic surveillance study has initiated in the
UK, US, and Latin America
Novacyt’s COVID-19 portfolio continues to be supported by
independent validations and accreditations:
- The DHSC Technical Validation Group reported the successful
completion of the in-service validation of PROmate™
- AstraZeneca reported the successful implementation of saliva
testing of staff using Novacyt’s genesig® COVID-19 assay
Expansion of the SNPsig® portfolio
With the rapid emergence of significant SARS-CoV-2 variants, the
Company has expanded the polymerase chain reaction (PCR) genotyping
portfolio, SNPsig®, announced on 2 February 2021, to incorporate
the detection of two new variants of concern (VOC), first
identified in Bristol (202102/02)1 and California
(B.1.429/CAL.20C)2. These additions demonstrate the Company’s
ability to match the rapid evolution of the virus with real-time
bio-informatics surveillance and accelerated product development.
The variant diagnostics surveillance study, also announced on 2
February 2021, has initiated in sites in the UK, US and Latin
America, enabling scientists and healthcare professionals in the
field to determine the incidence of the principal VOC in their
populations and to formulate strategies for containment and / or
specific patient management.
Launch of CE Mark COVID-HT Direct
Novacyt announces the launch of its next generation
high-throughput PCR test for COVID-19 (COVID-HT Direct), which has
been CE Mark approved. This follows the launch of the Company’s
first high-throughput PCR test for COVID-19 (COVID-HT) in June
2020. The new test eliminates the need for automated extraction
systems in a high-volume PCR laboratory, reducing processing time,
cost and labour of testing by up to 30%. COVID-HT Direct is already
in use at one of the UK’s Lighthouse laboratories and is being
validated for use with private high-throughput PCR laboratory
partners.
Development of an antibody lateral flow test for
COVID-19
The Company continues to work on developing an IgG antibody
lateral flow test (LFT) for use as a rapid antibody test for
professional use. An LFT is an easy-to-use diagnostic device used
to confirm the presence or absence of a pathogen or biomarker and
takes approximately 10-20 minutes or less to provide a result.
The Company expects to launch its LFT in Q2 2021, slightly later
than planned as it has taken the strategic decision to develop a
next generation of LFT to detect the neutralizing antibodies
generated by successful immunisation and, therefore, to assist in
monitoring the effectiveness of future vaccines 3. The Company
believes this exemplifies how it can extend the revenue horizon for
COVID-19 as the demand for testing continues to evolve.
Development of a loop-mediated isothermal amplification
COVID-19 test
Further to the announcement on 16 November 2020, the Company has
completed early studies using its loop-mediated isothermal
amplification (LAMP) technology with its q16 and q32 instrument
platforms and open LAMP platforms and demonstrated encouraging
initial results. Novacyt continues to evaluate the ongoing
opportunity for LAMP testing and will launch its technology subject
to demand.
Development of a new test panel to detect aspergillosis
fungal infections
Aspergillosis is an infection caused by aspergillus fungus
common in immune compromised patients4, and more recently has been
associated with co-infection in patients with SARS-CoV-25
infections and COVID-19–associated pulmonary aspergillosis6. The
infection is associated with long-term ventilation of patients.
Outside of SARS-CoV-2 infections, aspergillosis also remains a
potentially serious respiratory infection, affecting ~5 million
patients worldwide7.
Novacyt’s new multiplex PCR assay panel will detect all five
major aspergillus sub-types and will run on the Company’s q32
instruments, as well as open platforms. Novacyt expects to begin
validation studies soon, with the potential to launch during H2
2021.
Once launched, the new assay panel will be the second product in
the Company’s COVID-19+ portfolio, following the launch of the
Winterplex™ multiplex assay panel in August 2020. This launch is
also in line with Novacyt’s strategy to expand its portfolio of
clinical use, respiratory diagnostic products.
Development of a two-gene target PROmate™ test
Following the early success of the PROmate™ test to improve
workflow efficiency when used with the Company’s q16 and q32
instrument platforms, Novacyt is developing a two-gene version of
this test to support those markets and use cases where a two-gene
target test is required. The same operational benefits will be
available for customers.
Successful completion of clinical trial with Queen Mary
University of London
Further to the announcement on 16 November 2020, Queen Mary
University of London (QMUL) has completed the clinical trial using
the Company’s rapid testing platforms for COVID-19 in care homes.
Upon completion, over 4,500 samples and subsequent results have
been recorded. The data analysis is now underway, and the results
are expected to be reported in H2 2021.
Successful completion and publication of TVG validation of
PROmate™
As stated in the announcement on 29 January 2021, the UK’s
in-service validation of the PROmate™ assay using the Company’s q16
and q32 instrument platforms was successfully completed in December
2020 and published by the Technology Validation Group (TVG) in
January 20218.
The independent study was undertaken at four NHS laboratories
with 759 samples, including 242 positive and 517 negative samples.
Analysis of the results demonstrated a very high level of
sensitivity and specificity, aligning the performance of PROmate™
with the Medicines and Healthcare products Regulatory Agency
standard for point-of-care (rapid testing). This TVG accreditation
supports the use of the q16/q32 and PROmate™ system in a near
patient setting. PROmate™ is the only direct-to-PCR assay with TVG
validation and reiterates the Group’s position at the forefront of
PCR technology.
Successful implementation of saliva testing of AstraZeneca
staff using the genesig® COVID-19 assay
In early 2020, AstraZeneca set up an internal programme of
voluntary SARS-CoV-2 testing for asymptomatic employees in the UK
and Sweden using Novacyt’s genesig® COVID-19 test. By
February 2021, approximately 70,000 SARS-CoV-2 PCR tests had been
completed within AstraZeneca’s internal global testing centres, of
which 54,000 are based on saliva swabs. Following the introduction
of saliva testing, adoption by employees increased approximately
four-fold and over 90% of 1,062 employees surveyed expressed a
preference for the change from the typical oropharyngeal (throat)
or nasopharyngeal (nasal) swabs. The study highlights the 90%
uptake of saliva testing for asymptomatic patients and the
excellent detection rates of 0.33 copies of whole viral genome
RNA/µL, sensitivity of ≥95% and 100% specificity.9 These result
shows how PCR testing can be used for asymptomatic
mass-testing.
Graham Mullis, Group CEO of Novacyt, commented:
“Novacyt remains focused on leveraging its innovative reputation
and position in the rapidly changing COVID-19 testing market to
continue to deliver value and support clinicians and laboratories
in a global setting. Of note, following its launch, our PROmate™
test has been well received by users and opens up new opportunities
for rapid PCR testing, including in private testing markets. In
addition, we look forward to presenting exciting long-term plans
for Novacyt during Q2 this year as we continue to define our
strategy for delivering sustainable, long-term growth.”
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
1 PHE: Investigation of SARS-CoV-2 variants of concern in
England, Technical briefing 6, 13 February 2021 2 Zhang W, Davis
BD, Chen SS, Sincuir Martinez JM, Plummer JT, Vail E. Emergence of
a Novel SARS-CoV-2 Variant in Southern California. JAMA. Published
online February 11, 2021. doi:10.1001/jama.2021.1612 3 "Covid:
South Africa halts AstraZeneca vaccine rollout over new variant".
BBC News. 8 February 2021 4
https://www.cdc.gov/fungal/diseases/aspergillosis/index.html 5 Lai
CC, Yu WL. COVID-19 associated with pulmonary aspergillosis: A
literature review J Microbiol Immunol Infect.
2020;S1684-1182(20)30238-3. doi:10.1016/j.jmii.2020.09.004 6
Salmanton-García J, Sprute R, Stemler J, Bartoletti M, Dupont D,
Valerio M, et al. COVID-19–associated pulmonary aspergillosis,
March–August 2020. Emerg Infect Dis. 2021 Apr.
https://doi.org/10.3201/eid2704.204895 7 Denning DW, Pleuvry A,
Cole DC. Global burden of allergic bronchopulmonary aspergillosis
with asthma and its complication chronic pulmonary aspergillosis in
adults.external icon Med Mycol. 2013 May;51(4):361-70. 8
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/957995/TVG_Report-PROmate.pdf
9 Nikki Carter, Maryam Clausen, Rebecca Halpin et al. A novel,
automated SARS-CoV-2 saliva PCR test protects a global asymptomatic
workforce, 17 February 2021, PREPRINT (Version 1) available at
Research Square [https://doi.org/10.21203/rs.3.rs-246781/v1]
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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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