Member Info for RegulatorUK

“ Why’s that regulator? What is the good news here that I am missing?”

Do you invest in the company whose test may take months to fix? Or do you invest in the company whose test works?

The Avactolytes aren’t going to be happy this morning, if they really understand the content of this morning’s RNS.

https://www.lse.co.uk/rns/AVCT/update-on-affidx-and-detection-of-omicron-variant-x2zwsj4vf49p42n.html

Wouldn’t be surprised to see some money flowing this way…

“Could be an interesting PMQ's with Angela Raynor standing in.”

Time to start retweeting the hell out of this and tagging in your local MP: https://twitter.com/ukregulator/status/1478670802438479877?s=21

I’m sorry… want to try that in comprehensible English?

“ new variants and mutation will keep coming as long as there is winter season,which is throughout the whole year, and until they realised that what they actually think is mutation or new variant is actually just "seasonal flu". “

Just ‘seasonal flu.

Remind us where you got your degrees in virology and epidemiology maqsood7…. University of Facebook?

"good posts RegulatorUK, but not many recommendation as this board is full of boilerroom posters."

I have a veritable sea of green boxes. TW's acolytes must be working overtime to pay for their Christmas Buckfast...

The two links in my previous email seem to have incorporated the final parentheses. The corrected links are:

https://www.gov.uk/government/collections/weekly-national-flu-reports

https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/seasonal-influenza/surveillance-and-lab-network

I note that over the festive period another test was approved - this one from Turkey!

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1043967/Products_approved_under_the_Medical_Devices__Coronavirus_Test_Device_Approvals___Amendment__Regulations_2021-_24122021.ods

"yes we will be living with covid as we do with Flu, Virus will eventually mutate into a very mild disease and there will be no need for mass testing."

Do remind me where you got your degrees in virology and epidemiology? University of Facebook perchance?

"Do we test for flu ? No and we wont test for Coronavirus in the future."

Yes - we do test for 'flu. And have done for years (https://www.gov.uk/government/collections/weekly-national-flu-reports).

We're part of an international structure of testing for 'flu (https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/seasonal-influenza/surveillance-and-lab-network) - it's partly how we identify the prevalent strains and create the annual 'flu vaccines.

You do come across as remarkably ill-informed.

"@SundayTimesScot - Prof Peto states UK Co's are "whingeing" - not a very professional or scientific analysis. US banned Chinese LFTs as inferior. #ODX test id'd as 'Gold Standard' after trials. Are Prof Peto's pals up to same 'gold standard' of approval? @johnredwood @Omega_ODX "

I know one of Tim Peto’s colleagues, who described him as a “bit of a dick”. She described his comments as “totally unprofessional “.

“ I wish he was prime minister - read his blog - he speaks up for the english but the left wing media seize every opportunity to rubbish him because they are scared of his interllect and common sense.”

The man is a moron. To call him an intellectual pygmy would be an insult to pygmies. But he does seem to curry favour with a certain demographic…

"The reply does not mean that if the government order is not forthcoming - as appears to be the situation today - that HMG will not allow the machinery to be used."

That's a very 'nuanced' reading of what is a remarkably clear statement.

I haven't made an assertion. I've said that there's some early data (not yet in preprint) which suggests that nasal only swabbing *may not* be sufficient...

There's some interesting early data emerging around LFTs and Omicron, which suggest that nasal only swabbing may not be sufficient and we may need to go back to oropharyngeal swabbing as well. Which won't be an issue for the Visitect test, which was designed originally as a combined test - but may have an impact on some of the newer entrants to the market. W

What Omicron does show is that this pandemic is not over by any means and we may need to be more agile in the way we deal with particular variants. Which means UKHSA needs to pull it's finger out...

I suggest people follow Michael Mina on Twitter if you want to know what is going on with testing in the USA.

There are real echoes of the s**tshow that is happening here in the UK...

As an AVCT holder I'm pleased by this morning's RNS (nice early Christmas present)...

...but that RNS has overegged the pudding and I'm afraid some people will be in for a rude awakening.

As I said over there, the UKHSA is screwing up big time. To date, after three months, it has only authorised 13 tests out of the hundreds that have been submitted - and of those manufacturers, only one is actually British. The rest are overseas manufacturers (albeit that some of them have UK manufacturing bases).

I would expect to see another tranche of approvals before Christmas and the next set of restrictions... but I can see legal action happening fairly soon, as some of the UK developers/manufacturers lose patience with the obfuscation, delay, incompetence and corruption surrounding the CTDA system.

"there are no NHS tests........"
"NHS tests still available online"

There are national shortages of LFTs in the UK, thanks to the CTDA regulations and the incompetence of the UKHSA.

NHS providers used to provide their staff with LFTS - now those staff have to get them via the same online process as everyone else. Hospitals are being told that the LFTs they have must only be used for testing patients (and those tests are in short supply).

Whilst the online systems tell you that tests are available, particularly for collection at pharmacies, they quite often aren't. I got a collection code over the weekend - but when I got to the pharmacy they had run out three days before. They had told the central system but people were still being sent there to collect tests.

The UKHSA is screwing up big time. To date, after three months, it has only authorised 13 tests out of the hundreds that have been submitted - and of those manufacturers, only one is actually British. The rest are overseas manufacturers (albeit that some of them have UK manufacturing bases).

I would expect to see another tranche of approvals before Christmas and the next set of restrictions... but I can see legal action happening fairly soon, as some of the UK developers/manufacturers lose patience with the obfuscation, delay, incompetence and corruption surrounding the CTDA system.

"The UKCA marking came into effect on 1 January 2021. However, to allow businesses time to adjust to the new requirements, you will still be able to use the CE marking until 1 January 2023 in most cases.”

Except the CTDA regulations have superseded that.

The government has completely screwed up the medical devices regulatory process in this country.

"@RegulatorUK, a possible market of 67m people in the UK against 448m in the EU? Who needs the UK?"

I absolutely agree. Forget the UK for now - we need to concentrate on European sales, particularly if the mutterings in Germany are correct about the emergence of another new potential variant of concern.

I hold both ODX and Avacta (as well as a few others... but the less said about Nanosynth the better).

Our days will come in both shares - but we need to temper this good news with the fact that we still have to deal with the absolute shower of ****e that is the UKHSA.