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211 Postings ausgeblendet.

27.02.20 17:33

880 Postings, 2503 Tage nosce@achilles

alles sehr spooky bei nova.......  

28.02.20 08:24

880 Postings, 2503 Tage nosceupdate

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HISTORICAL PERFORMANCE

1WYTD52WHighest2.122.6752.675Lowest0.7950.1600.061%87.70676.33424­.80

Updated 28/02/2020 08:23:31 CET

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28/02/2020Novacyt S.A.:Coronavirus Test Update28/02/2020Novacyt S.A. :Mise à jour sur le test pour le coronavirus19/02/2020Exercice des derniers bons de souscriptions et émission d'actions19/02/2020Exercice de bons de souscription et émission d'actions18/02/2020Exercice de bons de souscription et émission d'actions

PRESS RELEASE

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Novacyt S.A.:Coronavirus Test Update

28 FEB 2020 08:00 CET

COMPANY NAME

NOVACYT

ISN

FR0010397232

MARKET

Euronext Growth

SYMBOL

ALNOV

Major distribution agreement for COVID-19 test

Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt" or the "Company"), an international specialist in clinical diagnostics, is pleased to provide an update regarding the novel coronavirus (COVID-19) test developed by Primerdesign, its molecular diagnostics division, and announces it has signed a major distribution agreement in Asia and an original equipment manufacturer (OEM) agreement with a US healthcare group.

As of 27 February 2020, Primerdesign has sold over £0.93m (?1.1m) of CE-Mark and research use only (RUO) tests. Since launching its CE-Mark test, the Company is experiencing high levels of interest in its product. The value of quotations has grown significantly as Novacyt is currently involved in active discussions with representatives from a number of countries which have an acute need for tests as part of their national screening programmes. Due to the high level of interest in the Primerdesign COVID-19 test and rapidly evolving nature of this outbreak, the Company cannot predict with any certainty the conversion rate of these ongoing enquiries into orders.

Primerdesign has also signed its first major distribution agreement for the COVID-19 test with a global life sciences company to supply the test to two Asian territories outside mainland China. Initial sales, which are subject to local emergency use approval, are anticipated to be £2.1m (?2.5m) during the first six months of the agreement. It is expected that the first sales under this agreement will take place in March 2020.

The Company also announces that it has signed an OEM agreement with a US healthcare group for the manufacture and sale of its RUO coronavirus tests.

In addition, as previously announced, the Primerdesign test is currently under review by the US Food and Drug Administration (FDA) for Emergency Use Approval, which would allow the test to be used for clinical diagnosis of COVID-19 in the US. The FDA and the Company are in regular contact.

Public health authorities around the world are pursuing a variety of strategies when it comes to testing for COVID-19. For example, Public Health England (PHE) has issued testing guidance to the NHS to be deployed across eight testing centres in the UK. PHE as part of its planning has also invited diagnostic manufacturers (including Primerdesign) to submit tests for a formal evaluation process, which is expected to conclude next month. It is not known at this time what conclusions or guidance the PHE will subsequently give to the NHS for COVID-19 testing.

The current COVID-19 screening procedure in France involves directing all patient samples to the Institut Pasteur in Paris. It is not known at this time whether more widespread testing will be performed and what test methods will be approved for use in these hospitals and clinics.

Other health authorities around the world have approved tests for emergency use from local manufacturers and many are also currently reviewing the Primerdesign test. The speed and processes to gain emergency approval for tests differs from country-to-country depending on their approval process and the perceived threat level of COVID-19.

The Company has put in place a number of measures to significantly increase production capacity and continues to plan for greater throughput to ensure Primerdesign can meet all current and potential demand. These measures include, if necessary, using the Company?s manufacturing capacity at both its UK sites.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

?I am extremely pleased with the commercial interest shown in our test to date and to be able to support the global response to monitor and contain the COVID-19 outbreak. The two contracts announced today reinforce how quickly the response to this virus is developing and shows our commitment to support these efforts anywhere in the world.

?We believe the Primerdesign test remains among the quickest and most accurate tests available for COVID-19, as well as being stable for long distance shipping without the need for specialist cold-chain shipping. It is also designed to run on multiple molecular testing platforms commonly used around the world. I am proud of the team who are working extremely hard to meet the regulatory and manufacturing challenges to make our test available to as many affected countries as possible.?

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 

 

28.02.20 08:53

880 Postings, 2503 Tage nosce2 euro wären gut heute.....

28.02.20 09:01

880 Postings, 2503 Tage nosceHalted in Paris

28.02.20 09:04

880 Postings, 2503 Tage nosce!

Now got US manufacturer FDA is a given. 
Great update.  

28.02.20 09:24

43 Postings, 201 Tage achilles__Sehr gut!

28.02.20 11:38

880 Postings, 2503 Tage noscein USA

wäre die aktie bei 10 dollar, min.  

28.02.20 11:53

880 Postings, 2503 Tage nosce689000 stück mit einem schlag in paris gekauft wor

28.02.20 12:00

880 Postings, 2503 Tage nosce.

(Sharecast News) - Clinical diagnostics company Novacyt updated the market on its novel Covid-19 coronavirus test developed by its molecular diagnostics division Primerdesign on Friday.
The AIM-traded firm said it has signed a major distribution agreement in Asia, and an original equipment manufacturer (OEM) agreement with a United States healthcare group.

It said that, as at 27 February, Primerdesign had sold more than ?0.93m of both CE-mark and research use only (RUO) tests.

Since launching its CE-mark test, the company said it was experiencing high levels of interest in the product, with the value of quotations having grown significantly, as the firm was in active discussions with a number of countries which had an "acute need" for tests as part of their national screening programmes.

Due to the high level of interest in the test and the rapidly evolving nature of this outbreak, the company said it could not predict with any certainty the conversion rate of those ongoing enquiries.

Primerdesign had also signed its first major distribution agreement for the Covid-19 test with a global life sciences company, to supply the test to two Asian territories outside mainland China.

Initial sales, which were subject to local emergency use approval, were expected to be ?2.1m during the first six months of the agreement.

It expected the first sales under the agreement to take place in March.

The company also confirmed that it had signed an OEM agreement with a US healthcare group for the manufacture and sale of its RUO coronavirus tests.

In addition, as it had previously announced, the Primerdesign test was currently under review by the US Food and Drug Administration (FDA) for Emergency Use Approval, which would allow it to be used for clinical diagnosis of Covid-19 in the US.

The FDA and the company remained in regular contact.

Novacyt said public health authorities around the world were pursuing a variety of strategies when it came to testing for the coronavirus.

For example, it pointed out that Public Health England (PHE) had issued testing guidance to the NHS to be deployed across eight testing centres in the UK.

PHE, as part of its planning, had also invited diagnostic manufacturers including Primerdesign to submit tests for a formal evaluation process, which was expected to conclude next month.

It was not known at the current time what conclusions or guidance PHE would subsequently give to the NHS for testing.

The company said the current Covid-19 screening procedure in France involved directing all patient samples to the Institut Pasteur in Paris.

It was not known yet whether more widespread testing would be performed, and what test methods would be approved for use in those hospitals and clinics.

Other health authorities around the world had approved tests for emergency use from local manufacturers, and many were also currently reviewing the Primerdesign test.

The speed and processes to gain emergency approval for tests differed from country to country, the board explained, depending on their approval process and the perceived threat level of Covid-19.

Novacyt said it had put in place a number of measures to significantly increase production capacity, and was continuing to plan for greater throughput to ensure Primerdesign could meet all current and potential demand.

Those measures included, if necessary, using its manufacturing capacity at both of its UK sites.

"I am extremely pleased with the commercial interest shown in our test to date and to be able to support the global response to monitor and contain the Covid-19 outbreak," said chief executive officer Graham Mullis.

"The two contracts announced today reinforce how quickly the response to this virus is developing and shows our commitment to support these efforts anywhere in the world.

"We believe the Primerdesign test remains among the quickest and most accurate tests available for Covid-19, as well as being stable for long distance shipping without the need for specialist cold-chain shipping."

Mullis said the test was also designed to run on multiple molecular testing platforms commonly used globally.

"I am proud of the team who are working extremely hard to meet the regulatory and manufacturing challenges to make our test available to as many affected countries as possible."

At 0950  

28.02.20 14:18
1

880 Postings, 2503 Tage noscekomm, die 2 euro sollten heute fallen, min.:-)

28.02.20 14:21

43 Postings, 201 Tage achilles__2?

Würde mich freuen, zum Wochenende (-:

Was für Aktien hast du denn sonst noch so auf dem Schirm derzeit? Was mich sehr ärgert ist, 1 Jahr lang hat mein S&P 500 ETF 19% Plus angesammelt. Das hat sich alles in 5 Tagen in Luft aufgelöst. Wird sich das auch alles relativ schnell wieder erholen?  

28.02.20 14:23

880 Postings, 2503 Tage nosce@achilles

28.02.20 14:26

880 Postings, 2503 Tage nosce@achilles

28.02.20 14:29

43 Postings, 201 Tage achilles__Danke!

28.02.20 14:31

880 Postings, 2503 Tage noscenicht dafür....

28.02.20 15:45

24 Postings, 151 Tage spunkyWelche Rolle spielt byot oder wie kommst du drauf?

28.02.20 15:45

24 Postings, 151 Tage spunkyWie kommst du auf byot?

28.02.20 15:53

880 Postings, 2503 Tage nosce@spunky

handschuhe, schutzmasken etcetc.  

28.02.20 16:02

43 Postings, 201 Tage achilles__Wettbewerb

Wie steht ihr dazu, dass jetzt, nachdem klar ist, dass die Krise noch weitergeht plötzlich sehr viele Unternehmen solche Kits anbieten? Ich frage mich, ob Nova in der Lage sein wird, bei all den anderen Firmen herauszustechen..  

28.02.20 16:11

880 Postings, 2503 Tage nosce@achilles

es steckt wohl mehr dahinter, wenn Cnn und Skynews zum raport bitten........ die amis müssen noch bei nova die führung definieren, dann gehts los mit der FDA zulassung......... möglicherweise:-)  

28.02.20 16:16

880 Postings, 2503 Tage noscemöglicherweise übernehmen sie heute schon....

28.02.20 16:37

880 Postings, 2503 Tage nosceausm LSE board

The deal they have struck in the States will be a licencing fee for the IP plus a per unit royalty i would guess. Not so simple as xx amount of tests multiplied by xx amount of $s  

28.02.20 16:41
1

880 Postings, 2503 Tage nosceVolumen steigt schon mal,in Nasdaq.....

wenn wir glück haben, platz die aktie  im nachmittagshandel der amis.....  

28.02.20 17:36

880 Postings, 2503 Tage nosce1,73 euro schlusskurs in paris......lächerlich

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