JohnHenry - so the vaccine when it arrives will be given indiscriminately without the existence of the virus first being diagnosed by clinicians using a diagnostic test! Come on man, it's not even common sense what you're saying and the reason is, your negative on this stock. What's your real agenda JH!
The following email has just gone to the DM editor, Geordie Grieg, and Matt Oliver;
Dear Mr Greig,
Following yesterday's article by Matt Oliver, might you consider a follow-up article on the anglo-french company Novacyt? This small company is competing successfully with the pharma behemoths like Roche and has developed a world-leading diagnostic test for Covid-19. This test sits at the top of the Covid-19 assay table for a reason; it has 100% homology with Covid-19; hence it is described as an 'unmatched [diagnostic] tool'. It was granted emergency use authorisation by the U.S. Food & Drug Agency; was successfully evaluated by PHE in an independent clinical performance evaluation; has FDA approval in India, Argentina & the Philippines; is endorsed by the WHO.
On or around the 4th February, Novacyt submitted its application to the US Food & Drug Agency for the emergency use of its diagnostic test. Coincidentally, on this date, the Centers for Diseases Control in the US had its test authorised by the FDA for emergency use. Within days the CDC'S test failed because the reagent element was unreliable, leading to the recall of this test from all 32 labs that it had been sent to in the U.S. As a result of this, the US was effectively left without a diagnostic test for Covid-19 for almost the whole of February. The US chose not to use the WHO'S Covid-19 diagnostic test as a stopgap. This was a serious mistake and it is one that the US is now paying a price for! Concurrent with these failures was the FDA'S review of Novacyt's emergency use authorisation application. The FDA finally approved this application on 23rd March 2020!
In addition to the aforementioned accreditation and endorsements, NCYT'S test received a CE Mark accreditation on 12th February. In short, this test has been available here in the UK since the 31st January. PHE and the government have known about it's existence and its efficacy. What steps, if any, did they take to work with NCYT in order to scale up the availability of this test here in the UK because as Matt Oliver correctly reported, most of the tests have been sold to other countries.
Novacyt has scored an impressive hat-trick of diagnostic tests for the world's most challenging and dangerous diseases, SARS, Ebola & now Covid-19. This company's Covid-19 test should have been at the forefront of the fight against the virus here in the UK. Why has this not been the case?
P.S. Please refer to the updated Covid-19 Assay document, dated 30th March, on Primerdesign's twitter page. This document will provide you with all the evidence you require about the accuracy and reliability of NCYT'S diagnostic test.
At some point in the future the government will be held to account for all of this, and it will not withstand scrutiny. Public Health England just like the CDC and FDA in the US will also be put under the microscope. There will be reform and resignations!
It will be interesting to see if Michael Gove is front and centre at today's news conference, or will he be substituted? Who knows, he may even develop mild symptoms today
shouldaboughtmore - not heard from you since 13th March. Nothing's changed though, you're still trying to spread negativity. Here's your pst from Feb 28th;
'W.H.O. has been sending test kits to 56 different countries for weeks, this is to 150 laboratories on top of this'.
Pity you didn't buy any; shouldaboughtsome would be a better handle for you.
I think the company will respond to the media reports via the RNS this morning. It has been dragged into a wider public interest argument. Tomorrow, this will be yesterday's news. Today, however, the government has serious questions to be faced and a further news conference later today. The media reports will not derail NCYT. Every test we make, we sell, Pipeline of news is still positive. U.S. sales updates and further contract news to come. Keep the faith!
From: Robert Peston
Sent: 31 March 2020 22:31
Subject: Re: Diagnostic testing in the UK
Thanks XXXXXXXX. I am now immersing myself in all this. Sorry to have been distracted a bit by other aspects of the crisis.
ITV Political Editor
B2HS2L - Yes, that's how I've read it.
Further email to RP
It may be worth taking a closer look at the Thermo Fisher diagnostic test.
Whilst researching, I came across this document, (6/3/20)
Look at Appendix 8. Testing Systems Under Evaluation By PHE.
Primerdesign / Novacyt's test is featured in Appendix 8, pp 24-25 but Thermo Fisher's test - the TaqPath COVID-19 - is not listed!
However, on or around 17th/18th March a contrived photograph of two men carrying a box away from 10 Downing Street with Thermo Fisher emblazoned across it, was published in the Daily Mail.
The questions are;
Did the government purchase tests from Thermo Fisher?
If so, how many?
Were these tests the subject of an Independent Clinical Performance Evaluation (ICPE) by PHE prior to purchase?
If so, what was the outcome in terms of their efficacy?
How long were the TF tests evaluated for?
When did PHE'S evaluation end and what date were they accredited, if indeed they were so?
Do the TF tests have 100% homology with Covid-19? Particularly relevant in light of Chris Whitty's comments last week about the need for accurate and reliable tests.
Novacyt's diagnostic test received a CE Mark accreditation in mid-February and a successful ICPE by PHE by 12th March. Their test went on to attain US FDA emergency use authorisation. Therefore, the very test that the UK needed has been here in the UK since January, (long before Thermo Fisher arrived,) picking up accreditations and endorsements.
NCYT is an anglo-french company
Further to your tweet just now, I'm not sure Gove's claim that the unavailability of the reagents for the testing kits is a problem. Novacyt appears to have successfully sourced the test components needed for 18 million tests, including the reagent elements. These have been sourced by the company and its third party manufacturers; Yourgene (Manchester) and Bio Type (Dresden.) In any event, there are a number of specialist, pharma CDMO'S (Contract Development Manaufacturing Organisations) that are Good Manufacturing Practice-Compliant in Europe and across the world for whom sourcing the test components should not be an issue, even in the current climate.
I am afraid to say that the alleged lack of reagents looks like a smokescreen.
Can you put Gove to proof on this?
B2HS2L - PHE'S independent clinical performance evaluation of NCYT'S test was therefore completed between 6th March and 12th March when NCYT, per RNS, announced the successful outcome of this evaluation. Then, on 16th March, NCYT in a further RNS announced a further uptake of its test by 8 NHS Hospitals, following the evaluation by PHE.
hinukami - thanks for your endorsement. The SNG bb has deteriorated in the last few days. Have a look at my reply earlier today to xyz regarding FINNCAP'S note. Won't go into it further as this is the NCYT bb, save to say I'm realsitic and optimistic in equal measure! Think it was around 12.30ish the post
Handy111, good of you to say that. I've been doing a fair bit away from this board that people are not aware of because I have not shared it. It would be great if ITV and RP now did a feature on NCYT in one of their news bulletins. I'll certainly be watching out for this in the next few days. GL
Wilson63 - Disappointing in view of my email exchanges with RP earlier, although the first question from the BBC journalist was about testing, which didn't help. The whole testing issue stinks. The government has failed to get a grip of it since the WHO said, 'test, test, test'. Keep faith with NCYT!