Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
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The statutory instrument covers Innova with a new inclusion in this latest edition
https://www.legislation.gov.uk/ukdsi/2021/9780348224795
"They also provide for exemptions from that procedure for public service use and provide that the Secretary of State must establish a register of approved coronavirus test devices. There are transitional provisions in respect of devices placed on the market before 31st October 2021. Regulation 10 requires the Regulations to be reviewed, and a report published on or before 31st December 2022."
DHSC/Sajid David/BJ have been working night and day as Neave was told in the House so this is the result of the hours put in.
Waugh should not be stirring as it seems to me effort is finally able to go into the UK diagnostics from now on. How do you cope with a pandemic in the beginning with no tests and with PD/regulation in the interim and criticism in the finale? It has not been easy but AS and the cabinet have actually been remarkably aligned by the obstacles in the way and best endeavour to find a way through.
iPhone the government has just created a desktop review regulatory body with a different remit which Innova does not need to pass but those firms blocked by PD can, potentially. Not sure if your " government document stating this has been out for months"is directed at this latest development of 5 days ago or not? if not, what document?
28/7/21:
https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply?utm_medium=email&utm_campaign=govuk-notifications&utm_source=08b8bf3b-5a84-4d08-affc-0bdb795d3871&utm_content=daily
update 30/7: Removed test performance guidance and technologies validation group guidance.
With or without HMG, our ability to sell in the UK has been given far greater chance with new reg’s, threats to end free tests, desktop review at PD. And don’t forgot, we have MHRA approval to sell in the UK - we’re going to be selling into bathroom cabinets by summer end.
Huff Post:
“By appointing themselves ‘judge and jury’ of the Innova test, the DHSC has allowed itself to make fundamental changes to the Innova test’s characteristics, implementing them without any follow up Porton Down assessment.
“[These are] changes that would inevitably have had a significant detrimental impact on the test’s already underwhelming performance. Notably, to date, the government have not seen fit to publicly assess the impact of these wholesale changes.”
Yes, Paul’s done some research, but the above paragraphs are taken word for word, from my open letter to MP’s from a few weeks ago. Anyway, he’s welcome to it. About time this absolute scandal got more into the public domain.
AgentB , yeah you have nailed the problem, so frustrating.
But if our PCR tests are set at 40 amplification cycles, they could pick up on infections that occurred before the holiday even started. Until they dial down PCR to reflect true infectiousness (27 cycles according to AS) lateral flow tests are always going to look inadequate if they return a negative result and the ‘confirmatory gold standard’ test comes back positive.
All governments apparently wilfully ignorant of this flaw in the testing regime.
Interesting article in The Guardian....
“Travellers will still have to take a pre-departure rapid antigen or PCR test before travelling back to England (NHS tests can’t be used), and a PCR test on or before day two after their arrival. However, they will no longer need to take a day eight test.”
“However, the government says it “closely monitors” performance. All private providers of Covid tests must meet minimum required standards and are reviewed by the independent United Kingdom Accreditation Service (Ukas). If a provider fails to meet standards, they receive a five-day warning, and can be removed from the official lists if they don’t improve.”
So NHS tests are no good......but all other listed tests are closely monitored by UKas!
Mmmm gonna throw a spanner in the works it there is a new testing standard. Even if that is the case it will be phased in so that it’s too late!
The mind boggles!
https://www.theguardian.com/money/2021/jul/17/holiday-covid-tests-best-price-trust-time-provider
Trek
Well that is a good point beinthlead. If they DID include Innova as needing the same evaluation and it showed poor results… how would that look? Clearly they don’t have confidence it would stand up to scrutiny, otherwise it would be require the same evaluation as any others. There is nothing preventing the EUA being extended whilst the evaluation is done. Someone knows better than to put it out there for scrutiny.
I’m reality, Innova is done. The clause is there as a safety net, should they need bucket loads of tests at short notice, should another mass lockdown occur. Simple risk mitigation.
The new market won’t require Innova, or orient gene.
Yes this clause was known about when the changes came in. I think this article is actually good news. Paul has done a lot of research and spelt it out nicely. At least the shadow HS has actually made a comment. The more this gets the more pressure there will be to buy better UK tests. It is embarrassing for a brexit government… but more press needs to cover it.
Bighero you should enjoy duck while you can, because when your short burns here, you will be lucky to afford a pot noodle!!
Gla
A dead duck that’s selling more tests than any other British manufacturer.
This exemption clause isn’t new information, it’s been known for weeks. But great to see another candid story about the shenanigans.
Your local hero has been thinking more about this and feels it’s a disgrace for all the tests that should be used but aren’t. Although in Bighero’s view Avacta seem to be the ones lagging in any kind of PR and now look like an injured duck. Not quite a dead duck but a wounded one that might not make it. Maybe they will make a few sales but Mologic are all over the press. Maybe Affimers are not all they were cracked up to be? I can see another duck dish for my growing menu. Tasty.
The government have a lot to answer for and the question that needs answering is why???? Why let machines gather dust? Who gains? Someone out there is getting something… the incompetence can’t be THIS bad - especially for a BREXIT governmentright?
One UK bio industry source said: “They completely screwed the UK diagnostic industry. They invested in LFD [lateral flow device] machinery and are refusing to allow the factories to use them. Our firms are having to export world leading tests, two are in the top ten globally, while we import inferior ones.”
Thanks FTS. PW Clearly been working on that piece for a while - shame there’s not a piece about Delta, and our detection.
https://twitter.com/paulwaugh/status/1421892730939138050?s=20