nieuws Novacyt

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Nog het nieuws van 2 december.

Holdings in Company
Paris, France and Camberley, UK – 2 December 2020 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that it was notified on 1 December 2020 that, as at 30 November 2020 BlackRock Inc.’s holding in the Company on a voting and capital basis is 3.54% (2,500,373 shares).

novacyt.com/wp-content/uploads/2020/1...
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Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Development of three tests for new strains of COVID-19 and avian influenza

Paris, France and Camberley, UK - 14 December 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the launch of its research-use-only (RUO) polymerase chain reaction (PCR) test for a new strain of COVID-19 and the development of two new RUO PCR tests for avian influenza following recent outbreaks across Europe.

Voor meer, zie link:

www.voxmarkets.co.uk/rns/announcement...
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Novacyt S.A.

("Novacyt", the "Company" or the "Group")

COVID-19 diagnostic tests remain able to detect all published virus strains

Paris, France and Camberley, UK - 21 December 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that following the detection of a new variant of COVID-19 by the UK's COVID-19 Genomics UK consortium, known as VUI-202012/01, the Company has carried out a detailed analysis of the mutations in this new variant and in all published COVID-19 strains to fully assess the reliability of its existing diagnostic tests.

The results of the in silico (computer simulation) analysis of the sequenced mutations show that the Company's polymerase chain reaction product portfolio, based around a single and a two gene target for COVID-19, remain able to detect all published COVID-19 strains with the same high level of accuracy, including VUI-202012/01.

The Company notes this new strain of the virus has also been identified in other countries, including the Netherlands, Denmark and Australia.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

"These data support the continued use of our tests, which remain accurate in detecting all published strains of COVID-19, including the latest variant. As part of our surveillance programme, we are committed to analysing our selected gene targets for COVID-19 against new published viral sequences to demonstrate ongoing accuracy and performance. We also remain in close contact with the Department of Health and Social Care and the NHS as we continue to focus our efforts on deploying our tests to hospitals and laboratories across the UK, as well as to our customers around the world."

Voor meer zie link:

www.londonstockexchange.com/news-arti...

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Novacyt S.A.

("Novacyt" or the "Company" or the "Group")

Executive Management and Proposed Board Changes

Paris, France and Camberley, UK - 5 January 2021 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that James McCarthy has been appointed as Chief Financial Officer (CFO), whilst Anthony Dyer has taken on a new role as Chief Corporate Development Officer (CCDO). Both appointments are with immediate effect.

Mr McCarthy will become a Board Director of the Company, subject to shareholder approval, at the AGM. Anthony Dyer will remain a Board Director until James McCarthy is elected to the Board.

James has held a number of senior positions in major listed and private equity-backed businesses. Most recently he was CFO of Flint Group, a $2.5bn revenue, PE backed business with 7,900 staff and 180 sites across 40 countries. Previously, he was CFO of Brambles Plc's EMEA CHEP business before being promoted to President of CHEP's European team. Brambles Plc is an Australian-based, ASX listed business with a market capitalisation of AU$16bn. James trained as an accountant with Dairygold, receiving his ACCA qualification in 1988, before going on to work for a range of businesses including Unilever and ICI Plc.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

"On behalf of the Board, I am pleased to welcome James to the role of CFO. He joins Novacyt having held senior finance positions at a number of large blue-chip manufacturing organisations. His considerable financial, commercial and Board experience will be invaluable as Novacyt embarks on its next stage of growth.

"I would also like to take this opportunity to thank Anthony personally for the key role he has played in helping transform Novacyt into a leading diagnostics developer and manufacturer. His new, important role reflects the Company's growth strategy, which includes selective potential M&A to supplement organic growth initiatives. I look forward to working with Anthony and James as part of an expanded executive team."

The information required by Rule 17 and paragraph (g) of Schedule 2 of the AIM Rules for Companies in relation to the appointment of James Martin McCarthy (age 54) is as follows:

Current directorships

Past directorships held within last five years

Energy Transition Forum Limited

CHEP Israel Limited

Focus4Value Limited

Xeikon NV.

XBC BV

Mr McCarthy holds 10,000 ordinary shares in the Company. There are no other disclosures required in accordance with Schedule 2(g) of the AIM Rules.

- End -

Contacts

Novacyt SA

Graham Mullis, Chief Executive Officer

Steve Gibson, Group Finance Director

+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

Allegra Finance (French Listing Sponsor)

Rémi Durgetto / Yannick Petit

+33 (1) 42 22 10 10

r.durgetto@allegrafinance.com / y.petit@allegrafinance.com

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

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

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

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END

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Novacyt S.A.
("Novacyt" or the "Company")
Holdings in Company

Paris, France and Camberley, UK – 13 January 2021 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that it was notified on 12 January 2021 that, as at 11 January 2021 BlackRock Inc.’s holding in the Company on a voting and capital basis is 2.95% (2,085,368 shares).

(ingekort)

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RNS Number : 9730M
Novacyt S.A.
26 January 2021
Novacyt S.A.

("Novacyt" or the "Company")

Holdings in Company

Paris, France and Camberley, UK - 26 January 2021 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that it was notified on 26 January 2021 that, as at 25 January 2021 BlackRock Inc.'s holding in the Company on a voting and capital basis is 3.02% (2,132,372 shares).

For further information, please refer to www.novacyt.com or contact:

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

Allegra Finance (French Listing Sponsor)

Rémi Durgetto / Yannick Petit

+33 (1) 42 22 10 10

r.durgetto@allegrafinance.com; y.petit@allegrafinance.com

FTI Consulting (International)

Victoria Foster Mitchell / Alex Shaw / Mary Whittow

+44 (0)20 3727 1000

victoria.fostermitchell@fticonsulting.com / mary.whittow@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

www.lse.co.uk/rns/NCYT/holdings-in-co...
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Full Year 2020 Trading Update

Paris, France and Camberley, UK - 29 January 2021 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an unaudited trading update for the year ended 31 December 2020.

Highlights

· Revenue for the full year of 2020 increased by over 20x to €311.6 million (£277.0 million) compared to €13.1 million (£11.5 million) for the full year of 2019

· Revenue of €239.2 million (£213.7 million) delivered in H2 2020 compared to €72.4 million (£63.3 million) in H1 2020

· Gross margin for the full year above 80%

· EBITDA profitability for the full year above €210 million (£187 million), with H2 2020 EBITDA above €161 million (£143 million) compared to €49.4 million (£43 million) in H1 2020

· The Company's cash position at 31 December 2020 was €101 million (£91.8 million), compared to €1.8 million (£1.6 million) at 31 December 2019 and €19.7 million (£18.0 million) at 30 June 2020

· Investment in pipeline of next generation COVID-19 tests to address evolving clinical needs

· Acquisition of IT-IS International, a profitable diagnostic instrument development and manufacturing company, in line with strategy

Overview

As a result of significant work, focus and innovation, the scale and financial performance of the business continued to accelerate during the second half of the year. This was driven by the continued successful global commercialisation of the Company's COVID-19 product portfolio, underpinned by one of the world's first approved polymerase chain reaction (PCR) tests for the virus, and has resulted in the rapid transformation of Novacyt into a leading European integrated molecular diagnostic player.

The strong cash position at the year-end followed significant investment in the Group's working capital, including inventory to meet product demand and ensure uninterrupted supply to customers, and the Group paying down all outstanding debt during the year, making the Company debt free for the first time in its history. On an ongoing basis, we expect conversion of EBITDA to free cash flow before acquisitions to be close to 80%.

Novacyt has successfully integrated the acquisition of IT-IS International Ltd (IT-IS), a profitable diagnostic instrument development and manufacturing company, which was acquired in line with the Company's stated growth strategy. The acquisition allowed Novacyt to become a fully integrated instrument and consumables player, with the ability to expand its product offering into broader COVID-19 opportunities and beyond. As detailed at the time of the acquisition, the Company is focused on delivering higher manufacturing volumes at IT-IS to reduce its cost of goods and therefore improve the gross margin of its instrument sales.

The Group has expanded its global presence, with the UK, Middle East, Germany and US being its four largest revenue generating markets. It has secured significant contracts with national governments, including two with the Department for Health and Social Care in the UK (DHSC), as well as with other national non-government organisations, for the supply of its COVID-19 products.

Novacyt continues to leverage its proven capabilities in PCR test R&D to expand the range of high quality and differentiated products it offers to its customers. This has resulted in ten further product launches during the year to address new needs in the market, which has driven diversification of the Company's revenue base. This includes a test panel to differentiate COVID-19 from common winter diseases and new reagents to aid PCR testing workflow for users.

"I would like to thank all employees who have helped Novacyt to achieve an outstanding year of growth and prepare the Company for an exciting future. Our strong financial position has enabled us to settle all outstanding debt, make a strategically important acquisition and conclude the year with significant levels of cash to reinvest in the business. These foundations ensure we are well positioned to continue to grow the business in line with our strategy of delivering long-term value to our shareholders."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

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Outlook

Novacyt has had a strong start to 2021 across the business, with demand for the COVID-19 product portfolio remaining strong. At this early stage in the year, it is difficult to provide a clear forecast on the financial performance for full year 2021. However, the Directors believe demand for the Company's COVID-19 product portfolio will remain strong throughout most of 2021, with continued conversion of new opportunities, including a number of planned product launches, and the expansion of the Company's VersaLab™ service to support private sector testing of infectious diseases, initially focused on COVID-19.

In addition, the Company continues to support the DHSC and the NHS following the deployment of its rapid PCR testing system, for the contract with the DHSC, announced on 29 September 2020, and the Company is in active discussions with the DHSC to extend this phase of the contract. Novacyt's PROmate™, a new product to improve the workflow efficiency when used with the Company's q16/q32 instruments successfully completed an in-service validation conducted by Test and Trace's Technology Validation Group (TVG), with the TVG concluding the performance of the PROmate™ aligns with the acceptable standard for point-of-care (rapid testing).

With the strengthened cash position of the Company, the business is able to continue to invest in innovation, organic expansion and external business development, in line with its growth strategy, to leverage its strong momentum as a leading European molecular diagnostic player in infectious diseases. Organically, Novacyt will continue to invest in its commercial infrastructure to deliver new products, as the Company continues to redefine its R&D pipeline and establish a direct sales force in key markets in the US and across Europe. The Company also continues to evaluate M&A opportunities and will consider additional bolt-on acquisitions to add strategic assets and functionality to the expanding Group.

The Company expects to announce its full year results in April 2021.

Graham Mullis, Group CEO of Novacyt, commented:

"2020 has been transformational for Novacyt. We have cemented our early mover advantage of developing one of the first tests for COVID-19 into an established position within COVID-19 testing and the broader diagnostics market. We have signed significant contracts with national governments, supplied our products to over 130 countries globally and continued to develop innovative testing capabilities to support laboratories and clinicians during these challenging times.

"I would like to thank all employees who have helped Novacyt to achieve an outstanding year of growth and prepare the Company for an exciting future. Our strong financial position has enabled us to settle all outstanding debt, make a strategically important acquisition and conclude the year with significant levels of cash to reinvest in the business. These foundations ensure we are well positioned to continue to grow the business in line with our strategy of delivering long-term value to our shareholders."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

novacyt.com/wp-content/uploads/2021/0...

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Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Launch of PCR genotyping assay portfolio to detect COVID-19 variants

Paris, France and Camberley, UK - 2 February 2021 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), 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."

- End -

www.voxmarkets.co.uk/rns/announcement...
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With over 20 years of experience in the development, manufacture and distribution of high quality diagnostic products for clinical and food laboratories, Microgen Bioproducts are proud of our reputation for exceptional customer service and sales support. Our clinical product range supports healthcare providers in improving patient health, whilst our comprehensive food diagnostic range helps manufacturers ensure consumer safety.

Microgen exports to more than 80 countries through a network of over 100 dedicated distributors, allowing the impact of our products to be utilised globally.

Met video, zie link:

microgenbioproducts.com/

(van de Novacyt site)
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Research and Development Update
Wed, 24th Feb 2021 07:00

RNS Number : 1141Q
Novacyt S.A.
24 February 2021

Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Research and Development Update

Paris, France and Camberley, UK - 24 February 2021 - 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.

www.lse.co.uk/rns/NCYT/research-and-d...
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Correction: Research and Development Update
Wed, 24th Feb 2021 18:30

RNS Number : 2611Q
Novacyt S.A.
24 February 2021

Novacyt S.A.

("Novacyt", the "Company" or the "Group")

Correction: Research and Development Update

This is a correction to the Research and Development Update announcement published at 7:00am on 24 February 2021 (RNS number 1141Q) which has been amended with the following underlined additions to make it consistent with the French announcement released on Euronext at 8:00am CET on 24 February 2021.

Under the subtitle '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 using independent validated data.

· The new COVID-HT Direct uses pharyngeal swabs collected in viral transport media (without guanidine) and saline

Under the subtitle 'Successful completion and publication of TVG validation of PROmate™'

· This TVG accreditation supports the use of the q16/q32 and PROmate™ system in a near patient setting, and its current deployment across the NHS and to international markets.

All other information remains unchanged. The full corrected announcement is included below.

Paris, France and Camberley, UK - 24 February 2021 - 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 using independent validated data. 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%. The new COVID-HT Direct uses pharyngeal swabs collected in viral transport media (without guanidine) and saline. 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.
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Deel 2:

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, and its current deployment across the NHS and to international markets. 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."

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 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

www.lse.co.uk/rns/NCYT/correction-res...
voda
0
Liquidity Agreement and Total Voting Rights
Mon, 1st Mar 2021 14:30

RNS Number : 7409Q
Novacyt S.A.
01 March 2021

Novacyt S.A.

("Novacyt" or the "Company")

Liquidity Agreement Monthly Update and Total Voting Rights

Paris, France and Camberley, UK - 1 March 2021 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces its monthly update in relation to ordinary shares traded under its ongoing liquidity agreement with Invest Securities SA (the "Liquidity Agreement"). The Liquidity Agreement is governed by French law and is further summarised in the 'notes for editors' section below.

During the period from 1 February to 28 February 2021, Invest Securities purchased 6,395 ordinary shares at a maximum price of €9.90 and a minimum price of €7.80 and sold 4,520 ordinary shares at a maximum price of €10.12 and a minimum price of €7.72 under the Liquidity Agreement. The total number of ordinary shares in the Company, which are held in treasury as at close of business on 28 February 2021, is 5,272.

Total Voting Rights

The total number of ordinary shares in the Company is 70,626,248. This figure may be used by shareholders as the denominator for calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company pursuant to Article L. 223-7 of the French Commercial Code and the Company's Articles. The Company is not subject to the disclosure guidance and transparency rules made by the Financial Conduct Authority under Part VI of FSMA.

For further information, please refer to www.novacyt.com or contact:

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

Allegra Finance (French Listing Sponsor)

Rémi Durgetto / Yannick Petit

+33 (1) 42 22 10 10

r.durgetto@allegrafinance.com/ y.petit@allegrafinance.com

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

FTI Consulting (France)

Arnaud de Cheffontaines

+33 (0)147 03 69 48

arnaud.decheffontaines@fticonsulting.com

www.lse.co.uk/rns/NCYT/liquidity-agre...

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