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  1. forum rang 10 voda 15 april 2020 17:52
    Novacyt S.A.

    ("Novacyt" or the "Company")

    Manufacturing and R&D update for COVID-19 test

    Paris, France and Camberley, UK - 15 April 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, provides a manufacturing, and research and development update on its polymerase chain reaction (PCR) test for COVID-19, developed by Primerdesign, the Company's molecular diagnostics division based in the UK.

    Manufacturing capacity

    Novacyt is focused on managing what it believes will be a period of sustained, significant demand for its COVID-19 test. The value of the current order book, anticipated sales contracts and the growing number of potential orders means further significant commitments to manufacturing capacity are being made.

    Further to the announcement on 30 March 2020, Primerdesign has now achieved the target run-rate of manufacturing its COVID-19 test at a rate of four million tests per month. To continue to meet demand, the Company is working to further increase this manufacturing capacity and has signed manufacturing partnership agreements with BioPharma Process Services Ltd and Biofortuna Limited, both based in the UK, to support its existing partnership agreements. In addition, Novacyt continues to scale-up its own production at its Primerdesign site in Southampton, UK. With this additional capacity, the Company expects, over the next three months, to increase production of the test to approximately eight million tests per month.

    As part of Novacyt's ongoing evaluation of additional capacity options, the Company is also in discussions with further potential UK-based manufacturing partners.

    In order to manage and support the planning, procurement and logistics for this capacity increase, Novacyt has engaged Chartwell Consulting, a specialist in rapid process improvement (www.chartwell-consulting.com). Chartwell has a team of senior consultants working within Novacyt to assist with the management of the scale-up plans to help deliver the planned increases in Primerdesign's production, and supply chain capacity.

    Given the planned increase in production, the Company has begun ordering additional raw materials to support this expansion. The Company is also expanding its key raw material supplier base for its COVID-19 test. Currently there are a total of 76 components required for its COVID-19 test and Chartwell is helping the Company to identify additional suppliers in order to develop a long-term and sustainable supply of its kits at this volume.

    Research and development update

    Novacyt has been working to address the current reported shortfall in extraction reagents required to perform PCR testing through the development of a new "direct-to-PCR" extraction method prior to running the Company's COVID-19 test. This removes the need for some scarce reagents and significantly reduces the number of extraction steps, allowing faster cycle times, higher throughputs and cost savings. The Directors believe this innovation should facilitate an increase in testing capacity for COVID-19, removing a current bottleneck in sample processing for laboratories. Novacyt expects to have this new extraction technology available to launch in May 2020.

    Graham Mullis, Chief Executive Officer of Novacyt, commented:

    "Our primary focus today is to expand Primerdesign's manufacturing capacity as quickly as possible to service the continued significant demand for our COVID-19 test. Whilst we are delighted with the progress we have made in ramping-up manufacturing capacity, we need to expand this further and are therefore putting in place plans to ensure we can continue to support our growing order book. This includes the appointment of a specialist consulting company to focus on operational efficiency, which will enable Novacyt to build a larger, sustainable supply-chain. I would like to thank our manufacturing partners and suppliers for their support during this pandemic."

    Andy Redfern, Partner at Chartwell Consulting, commented:

    "We are delighted to partner with Novacyt and work with its manufacturing and supply chain team to deliver a significant increase in throughput of an important test for COVID-19. The scale and pace of the ramp-up in manufacturing capacity is crucial as we support Novacyt in continuing to meet the demand for its COVID-19 test."

    Novacyt has also received emergency use approval for its test from the Federal Drug Agency of Saudi Arabia and from the National Agency of Drug and Food Control of the Republic of Indonesia, as well as import approval from the Drugs Controller General of India.

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

    - End -

    www.voxmarkets.co.uk/rns/announcement...
  2. forum rang 4 s.lin 27 april 2020 10:18
    Novacyt Signs Coronavirus Test Supply Contract With UK Government
    By Reuters
    April 27, 2020, 3:39 a.m. ET

    PARIS — Healthcare and clinical diagnostics company Novacyt has signed a supply contract with the UK's Department of Health & Social Care (DHSC) for its product aimed at testing for the presence of the coronavirus, the company said on Monday.

    Under the terms of the agreement, Novacyt will supply its coronavirus test to the DHSC for an initial term of six months, starting from May 4.

    Novacyt has initially committed to supply 288,000 tests per week to the DHSC for use in the UK's National Health Service, with the option to expand the agreement.

    www.nytimes.com/reuters/2020/04/27/wo...
  3. Lightet 27 april 2020 13:44
    quote:

    Forecast2006 schreef op 10 april 2020 07:27:


    Europa stelt 240 miljard beschikbaar voor medische apparatuur en testen om het coronavirus te bestrijden.

    Novacyt pikt hier een mooi graantje van mee.

    Nieuwe koersdoel is 10 euro.

    Fijne Paasdagen en blijf op veilige afstand.

    Kind regards,

    Forecast

    Zo hee, dat gaat lekker hier! Wat een ontwikkelingen en positief koersverloop zeg. Zelf heb ik hier ( nog) geen aandelen van. Wel van Pharming waarvan ik hoop dat, gezien de huidige ontwikkelingen bij hun, die koers net zo mooi gaat verlopen als deze! Vriendelijke groeten.
  4. forum rang 10 voda 7 mei 2020 06:50
    Grootste koersverandering
    Van de bedrijven op de kaart was Novacyt het aandeel met de grootste koersverandering, met een stijging van 110,36% in april. Novacyt is een Frans biotechnologiebedrijf dat zich richt op klinische diagnostiek.

    Net als vele andere bedrijven heeft Novacyt zich ingezet om de verspreiding van het Coronavirus tegen te gaan. De afdeling moleculaire diagnostiek, Primerdesign, heeft een test ontwikkeld die de aanwezigheid van het type Coronavirus uit 2019 kan detecteren. Andere testen voor het virus zijn naar verluidt minder specifiek en kunnen tot verkeerde uitkomsten leiden. Op 8 april 2020 plaatste de World Health Organisation (WHO) de test op de lijst van aanbestedingen voor dat jaar. Een voorwaarde om een jaar op deze lijst te mogen blijven staan, is dat de omstandigheden niet mogen veranderen. Na de aankondiging van de WHO stegen de aandelenprijzen met meer dan 22%.

    Novacyt meldde dat het per 28 april 2020 voor meer dan €103 miljoen aan testen voor COVID-19 heeft verkocht of bestellingen heeft ontvangen.

    Bron : DeGiro

    Voor meer, zie:

    www.iex.nl/Forum/Topic/1140214/7/Draa...
  5. forum rang 10 voda 2 juni 2020 13:08
    Novacyt shares fall on French refusal to refund virus test
    Matthias Blamont, Sudip Kar-Gupta
    2 MIN READ

    PARIS (Reuters) - Shares in healthcare and clinical diagnostics company Novacyt fell on Tuesday after a French regulator decided not to approve its novel coronavirus test for reimbursement, dampening Novacyt’s stellar stock market rally.

    France, in common with other European countries, is betting on mass testing for the covonavirus that causes the respiratory illness COVID-19, as part of its strategy to emerge safely from the epidemic.

    City laboratories in France that carry out testing almost exclusively use tests the country’s social security system reimburses.

    Shares in Novacyt were down 9% at 3.54 euros by 0915 GMT, although the stock remains up by more than 2,000% since the start of this year, spurred by a wave of contract orders for its testing product.

    The company has singled itself out with a test able to detect the coronavirus in less than two hours. Current testing, which can also identify other strains, takes up to a day.

    Novacyt said on Tuesday it had total sales and confirmed orders worth 135 million euros ($150.3 million) for the product, with new deals in Zimbabwe and across Latin America.

    Novacyt said although France’s Haute Autorite de Sante regulatory body had not approved its test for reimbursement in France, it could still sell the product there for private patient testing.

    Reporting by Sudip Kar-Gupta and Matthias Blamont; editing by Louise Heavens and Barbara Lewis

    Our Standards:The Thomson Reuters Trust Principles.

    www.reuters.com/article/us-health-cor...
  6. forum rang 10 voda 2 juni 2020 17:10
    Novacyt: cash pile builds amid Covid sales boom
    by Graeme Evans from interactive investor | 2nd June 2020 13:11

    Latest figures from the Covid testing kit firm show how transformational the past few months have been.

    In-demand Novacyt (LSE:NCYT) shares showed more signs of coming off the boil today, despite the company generating sales and orders for its Covid-19 tests some 10 times its 2019 revenues.

    The AIM-listed stock caught the imagination of retail investors after its early-mover success in developing a test for the coronavirus triggered a 3,000% rise for shares since January.

    They peaked at 529p on 16 April and became one of that month's most-bought stocks on the interactive investor platform, only to drift back towards the 300p mark in recent trading.

    Source: TradingView. Past performance is not a guide to future performance.

    There was plenty of encouragement in today's trading update, with Novacyt reporting sales for its Primerdesign Covid-19 test of £40 million alongside further orders worth £80 million. The total represents a £30 million rise on the figures reported just over a month ago, as well as a far cry from the £12 million of revenues generated by the whole business in 2019.

    Novacyt is now selling its test in more than 130 countries, with the biggest customers being the UK and Germany. It is also making progress in the US market, although in France the company has suffered a setback after regulators failed to approve the test for reimbursement.

    The Haute Autorite´ de Sante´ said this was because the Covid-19 test has been developed with one single gene target. Novacyt pointed out that the test already had clinical approval from the Institut Pasteur, an internationally renowned centre for biomedical research in France, adding that it can still sell the test in the country for private patients.

    Shares went as low as 300p Tuesday after the update and at lunchtime trade 8% lower at 309p. The recent decline may also reflect signs that the virus is losing its potency in many European countries, as well as the possibility that a vaccine could eventually reduce demand for diagnostic testing.

    Insider: bosses make fortunes backing Covid-19 winners
    Covid-19: winning AIM stocks fighting the virus
    Manchester-based diagnostics firm Genedrive, which has also seen a dotcom style surge for its shares on the back of its easy-to-use test for high-throughput coronavirus testing, has fallen back from 220p in early May to 151p today. It had been trading at 9p in late March.

    Novacyt CEO Graham Mullis pointed out that he expected demand for Covid-19 testing to continue to grow as new regions of the world are impacted by the pandemic.

    Zimbabwe’s Ministry of Health and Child Care has just awarded a contract for the supply of 1.5 million tests, which is the largest order secured by Novacyt outside of the UK so far.

    Novacyt is already committed to supplying 288,000 tests per week to the UK's Department of Health for use in the NHS, with the option to expand the agreement.

    It has an overall initial target of more than 10 million tests per month, which the Paris and Camberley-based company is meeting through eight dedicated manufacturing sites.

    The company is also working on further innovation to support laboratories during the pandemic, including a mobile Covid-19 system due to launch in July. Should the current level of activity continue across 2020, Mullis has predicted it will be “financially transformational” for the business.

    The low capital intensity of its manufacturing process has already enabled significant levels of cash to be generated, with Novacyt's balance sheet showing more than £8 million of cash at the end of April, compared with a closing 2019 balance of £1.6 million.

    Novacyt also stands to reap benefits from a much bigger base of global customers for its wider portfolio covering diagnostic products in oncology, microbiology and haematology.

    Why Genedrive shares are up 3,200% in just six weeks
    Stockwatch: two coronavirus stocks where momentum favours the brave
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    The Covid-19 polymerase chain reaction test was developed by its molecular diagnostics division, Primerdesign, which was founded in 2005 by Dr Rob Powell as a spin-out from Southampton University and funded by a single £30,000 loan. The business became profitable in its first year and required no further investment funding until its sale to Novacyt in May 2016.

    The pace at which the company acted on coronavirus shouldn't come as a total surprise, given that the Primerdesign division also developed molecular tests for other major incidents, such as the outbreaks of Swine Flu in 2009, Ebola in 2014 and Zika in 2016.

    These articles are provided for information purposes only. Occasionally, an opinion about whether to buy or sell a specific investment may be provided by third parties. The content is not intended to be a personal recommendation to buy or sell any financial instrument or product, or to adopt any investment strategy as it is not provided based on an assessment of your investing knowledge and experience, your financial situation or your investment objectives. The value of your investments, and the income derived from them, may go down as well as up. You may not get back all the money that you invest. The investments referred to in this article may not be suitable for all investors, and if in doubt, an investor should seek advice from a qualified investment adviser.

    Full performance can be found on the company or index summary page on the interactive investor website. Simply click on the company's or index name highlighted in the article.

    www.ii.co.uk/analysis-commentary/nova...
  7. forum rang 10 voda 3 juni 2020 08:42
    NOVACYT vereffent haar schulden

    AOF • 06/03/2020 om 08:09

    (AOF) - Novacyt heeft al haar uitstaande schulden aan Harbert European Growth Capital (HEGC) en Vatel Capital SAS (Vatel) afgewikkeld.

    Volgens de voorwaarden van de overeenkomsten zal Novacyt voor eind juni 2020 aan haar financiële verplichtingen jegens HEGC en Vatel voldoen. Hiermee zal de groep in contanten en door uitgifte van nieuwe gewone aandelen een totaal van 7 miljoen euro aan hoofdschuld verstrekt door deze twee kredietverstrekkers.

    Graham Mullis, CEO van Novacyt, licht toe: "We zijn verheugd de vervroegde afwikkeling van alle schulden van Novacyt aan te kondigen, mogelijk gemaakt door de sterke cashgeneratie van het bedrijf in 2020. Met een grote orderintake en de grondstoffen die we voor onze Covid-19-test hebben verkregen en de verwachte inkomsten uit nieuwe producten, we verwachten dat de sterke cashproductie zal voortduren. Ik wil HEGC en Vatel bedanken voor hun steun aan Novacyt in deze periode. "
  8. forum rang 10 voda 18 juni 2020 08:25
    Novacyt S.A.

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

    Launch of three innovative products to support

    COVID-19 testing

    Paris, France and Camberley, UK - 18 June 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the launch of three new products to support laboratories testing for COVID-19. These are Exsig™ Direct and Exsig™ Mag, two RNA extraction kits for use prior to running a polymerase chain reaction (PCR) test for COVID-19, and COVID-HT, a high-throughput test for COVID-19.

    Exsig™ Direct and Exsig™ Mag

    In addition to supporting laboratories through the supply of its COVID-19 test, Novacyt has developed two RNA extraction kits, Exsig™ Direct and Exsig™ Mag, to help address the current reported global shortfall in extraction reagents required to perform PCR testing. The extraction of RNA is a key pre-analytical step in COVID-19 testing and must be performed before running the PCR test on the RNA extract. The two kits can be used with all open instrument platforms for running a PCR test and offer customers different benefits; Exsig™ Direct provides significant workflow improvements whilst Exsig™ Mag offers enhanced sensitivity of the Company's COVID-19 test.

    Exsig™ Direct is an innovative direct-to-PCR extraction kit which removes the need for complex, automated magnetic bead extraction systems. It is designed to be used with the Company's COVID-19 test and is expected to significantly improve laboratory workflow, reduce cycle times, increase throughput by up to 50% and reduce costs. It uses a combination of optimised buffers to extract COVID-19 RNA from clinical samples. These buffers have been specifically designed and clinically tested to ensure the high level of testing performance of the Company's COVID-19 test is maintained. Novacyt also plans to optimise the use of this new extraction method in future PCR tests to be developed and launched by the Company.

    Exsig™ Mag is a new extraction kit designed to run on multiple automated magnetic bead extraction systems commonly used by clinical laboratories around the world. Exsig™ Mag has been developed to enhance extraction of COVID-19 RNA from clinical samples and, when used in combination with the Company's COVID-19 test, offers ultra-sensitive detection of COVID-19. Exsig™ Mag can also be used in combination with other COVID-19 PCR tests.

    COVID-HT test

    COVID-HT is a new test for COVID-19 optimised for use in laboratories performing high volumes of tests. The CE Mark test has been designed and validated to perform at the same high levels of specificity and sensitivity as the Company's existing COVID-19 test.

    COVID-HT uses the Company's proprietary master mix which, unlike the standard COVID-19 kit, requires no premixing, and the test components are packaged to facilitate a more streamlined workflow in a highly automated laboratory setting. As a result, COVID-HT is expected to improve operational efficiency and save time and labour associated with handling and preparing the test for use.

    Exsig™ Direct, Exsig™ Mag and COVID-HT are immediately available and manufacturing capacity has been developed to meet potential demand.

    Graham Mullis, Group CEO of Novacyt, commented:

    "As we continue to supply our COVID-19 test to laboratories around the world, we are delighted to provide further support through the launch of these new products. We believe there will be significant demand for our new extraction kits, particularly at this time when automated RNA extraction reagents are in short supply. In addition, our high-throughput test, for use in large volume clinical laboratories, should enable more efficient workflow which is critical to achieve optimal testing volumes. We look forward to continuing to work with our customers to support their testing requirements through new and innovative solutions."

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

    - End -

    www.voxmarkets.co.uk/rns/announcement...
  9. forum rang 10 voda 18 juni 2020 08:28
    Vertaalde versie:

    Novacyt SA

    ("Novacyt" , het "Bedrijf" of de "Groep" )

    Lancering van drie innovatieve producten ter ondersteuning

    COVID-19 testen

    Parijs, Frankrijk en Camberley, UK- 18 juni 2020 - Novacyt ( EURONEXT GROEI: ALNOV; AIM: NCYT ), een internationale specialist in klinische diagnostiek, kondigt de lancering aan van drie nieuwe producten ter ondersteuning van laboratoriumtesten voor COVID-19. Dit zijn Exsig ™ Direct en Exsig ™ Mag, twee RNA-extractiekits voor gebruik voorafgaand aan het uitvoeren van een polymerase-kettingreactietest (PCR) voor COVID-19, en COVID-HT, een high-throughput-test voor COVID-19.

    Exsig ™ Direct en Exsig ™ Mag

    Naast de ondersteuning van laboratoria door de levering van zijn COVID-19-test, heeft Novacyt twee RNA-extractiekits ontwikkeld, Exsig ™ Direct en Exsig ™ Mag, om het huidige gemelde wereldwijde tekort aan extractiereagentia aan te pakken die nodig zijn om PCR-tests uit te voeren. De extractie van RNA is een belangrijke pre-analytische stap in COVID-19-testen en moet worden uitgevoerd voordat de PCR-test op het RNA-extract wordt uitgevoerd. De twee kits kunnen worden gebruikt met alle open instrumentplatforms voor het uitvoeren van een PCR-test en bieden klanten verschillende voordelen; Exsig ™ Direct biedt aanzienlijke verbeteringen in de workflow, terwijl Exsig ™ Mag een verbeterde gevoeligheid biedt voor de COVID-19-test van het bedrijf.

    Exsig ™ Direct is een innovatieve direct-naar-PCR-extractiekit die de behoefte aan complexe, geautomatiseerde magnetische parelextractiesystemen overbodig maakt. Het is ontworpen voor gebruik met de COVID-19-test van het bedrijf en zal naar verwachting de laboratoriumworkflow aanzienlijk verbeteren, cyclustijden verkorten, de doorvoer met 50% verhogen en de kosten verlagen. Het gebruikt een combinatie van geoptimaliseerde buffers om COVID-19-RNA uit klinische monsters te extraheren. Deze buffers zijn speciaal ontworpen en klinisch getest om ervoor te zorgen dat de hoge testprestaties van de COVID-19-test van het bedrijf behouden blijven. Novacyt is ook van plan het gebruik van deze nieuwe extractiemethode te optimaliseren in toekomstige door de onderneming te ontwikkelen en te lanceren PCR-tests.

    Exsig ™ Mag is een nieuwe extractiekit die is ontworpen om te werken op meerdere geautomatiseerde magnetische kraalextractiesystemen die gewoonlijk worden gebruikt door klinische laboratoria over de hele wereld. Exsig ™ Mag is ontwikkeld om de extractie van COVID-19-RNA uit klinische monsters te verbeteren en biedt, in combinatie met de COVID-19-test van het bedrijf, ultragevoelige detectie van COVID-19. Exsig ™ Mag kan ook worden gebruikt in combinatie met andere COVID-19 PCR-tests.

    COVID-HT-test

    COVID-HT is een nieuwe test voor COVID-19, geoptimaliseerd voor gebruik in laboratoria die grote hoeveelheden tests uitvoeren. De CE-markeringstest is ontworpen en gevalideerd om te presteren op hetzelfde hoge niveau van specificiteit en gevoeligheid als de bestaande COVID-19-test van het bedrijf.

    COVID-HT maakt gebruik van de bedrijfseigen mastermix die, in tegenstelling tot de standaard COVID-19-kit, geen voormenging vereist, en de testcomponenten zijn verpakt om een ??meer gestroomlijnde workflow in een sterk geautomatiseerde laboratoriumomgeving mogelijk te maken. Dientengevolge wordt verwacht dat COVID-HT de operationele efficiëntie verbetert en tijd en arbeid bespaart die gepaard gaat met het hanteren en voorbereiden van de test voor gebruik.

    Exsig ™ Direct, Exsig ™ Mag en COVID-HT zijn onmiddellijk beschikbaar en de productiecapaciteit is ontwikkeld om aan de potentiële vraag te voldoen.

    Graham Mullis, Group CEO van Novacyt, merkte op:

    "Aangezien we onze COVID-19-test blijven leveren aan laboratoria over de hele wereld, zijn we verheugd om verdere ondersteuning te bieden door de lancering van deze nieuwe producten. We denken dat er een aanzienlijke vraag zal zijn naar onze nieuwe extractiekits, vooral in deze tijd waarin geautomatiseerde RNA-extractiereagentia zijn schaars. Bovendien moet onze high-throughput-test, voor gebruik in klinische laboratoria met groot volume, een efficiëntere workflow mogelijk maken die van cruciaal belang is om optimale testvolumes te bereiken. We kijken ernaar uit om met onze klanten te blijven werken om hun testvereisten te ondersteunen door middel van nieuwe en innovatieve oplossingen. "

    Deze aankondiging bevat voorkennis voor de doeleinden van artikel 7 van Verordening (EU) 596/2014.

    - Einde -
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