Member Info for RegulatorUK

"Could it be possible that two independent devices, depending on purpose, will be produced for the UK gov: one manufactured by Innova, and a second manufactured by ODX and others?"

The sovereign test programme is about having the domestic capacity to meet testing demand, rather than there being 'one test'. People have misunderstood the aim of the prgramme.

There will be multiple tests produced - and manufacturing companies like ODX will potentially make more than one test.

"@regulator - I understand you’re a bit of a weapon. How about sharing some information for fellow investors if you’re the font of all knowledge? Give some constructive corrections if needs be. Might be a more pleasant way to spend your day..."

I have done (over a significant period of time on this board) - it seems you're incapable of understanding what is being/has been said. You make assertions that simply don't stand up (as the LTHs on here will know).

Another numpty for the green bin it appears...

"I think it's a bit more than Omega's 2m a week. The article says "Millions per day!"
Does seem a very optimistic timescale and makes you wonder why we haven't been able to do it in this country for the last 18 months!!"

I think the article fails to understand the implications and demands of this type of manufacturing. You may well be able to put in place the actual manufacturing capacity relatively quickly - but it's about more than that. The key aspect are the quality systems, and those take significant time to put in place and have signed accredited. Without the correct quality accreditation, manufacturing capacity is somewhat irrelevant.

"If you actually understood what I was getting at, you might realise that I was suggesting that Innova has got nowhere near being suitable as a green light test."

Oh - I did realise that. I also realised you don't really understand what you're talking about...

"...but Innova definitely hasn’t after 80m+ tests being performed."

Oh dear... some people really don't know the facts, do they? The Innova antigen test passed the Phase 3 testing at PHE Porton Down in September last year ( https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/outcome-of-the-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices ). Phase 3 is:

"...to assess whether the lateral flow devices that passed phase 2 displayed performance characteristics desirable for mass population, community-based testing. The desirable performance characteristics are:

- very high specificity
- very high sensitivity against viral loads associated with infectiousness"

"So manufacturing the complete LFT is no longer a priority RegulatorUK, we can just tootle along making pouches and cassettes for somebody else??"

I think you misunderstand what "cassetting and pouching" actually means. It doesn't mean we're "making pouches and casettes" (we don't actually manufacture the cassettes) - it means we're assembling tests on behalf of another manufacturer. And getting paid to do it.

"I still feel angry that one of the UK's leading diagnostic companies has allowed itself to be relegated to making cassettes and pouches, a bit part player when it should have been playing a major role. Whatever happens from here on in, this needs to be fully investigated."

I hate to burst your bubble but, as a manufacturer rather than a developer, that's exactly what ODX's role is. To manufacture other people's tests... and we will do very well out of fulfilling that function.

"Then the government should publish the reliability and accuracy of the Innova test to compare against all the uk tests."

That's exactly what PHE is doing...

"Innova contract ends in June..... They were given emmergency use by the MHRA"

Not quite. Innova's tests were originally used under an Exceptional Use Authorisation granted to Innova. They were subsequently assessed and CE Marked for professional use in the UK and that EUA expired.

They are currently being repackaged and used for the national testing programme under an Exceptional Use Authorisation granted to to the Department of Health and Social Care and this EUA expires on 22 June (but could potentially be extended).

" With vaccine so far ahead now a specific test for covid isnt really going to a priority."

If the vaccine were "so far ahead" as you suggest, we wouldn't be facing a third wave...

Vaccination is only *one* part of a multi-modal approach that is needed to address Covid.

"God only knows what a LFT would cost in the US. Probably $3000"

It varies. Some states/cities/towns are providing them for free. Others have subsidised them - and in some areas it depends on whether your medical insurance will cover it or you can afford to buy them.

Testing has also tended to be focused on symptomatic patients and PCR based. However, there's a growing push for widespread asymptomatic testing using LFTs, led by people like Dr Michael Mina*.

*not the chef of the same name.

Anyone trying to read over between a drop in demand for testing in the USA and the UK clearly has little understanding of how very different the two healthcare and public health structures are.

I've just been accepted to the Covid Vaccine Booster Clinical Trial ( https://www.covboost.org.uk/ ). Testing is here to stay for a long time...

I see the fantasists are out in force...

"Regulator I have actually got a holiday from sugar beet! Enjoying my week off. How did your Spire end up?"

So you're a Fenlander....

Spire are still above offer price. I must get round to selling some of them.

"Is everyone still in bed?"

Out with the dog for an early walk and then work emails I'm afraid...

"People might be invested in both companies, but they should post on the boards that the post is referring to ."

Stop trying to police the board.

This is a BB for discussing matters relating to ODX and that includes what is happening with potential rivals, partners, etc.

If you don't like what is being posted you can flag it to the moderators or simply not read it.

"Reg. I believe that the Mologic test is in the PHE Phase 3a accredition system at Porton Down. I am led to believe that the Avacta test is not."

Yep. My reference to Mologic related to their partnership with Avacta - their own test (which we have also CE marked under the Visitect brand) is at Porton Down and I understand the next set of results should be soon.

"The mologic test may have CE already but not necessarily MHRA approval. To be honest im a bit lost with it all could do with a clarification from RegUK is they are about."

The Avacta test has been CE marked by Mologic for professional use. A file then needs to be submitted to MHRA for marketing authorisation in the UK. That is the step that has been ****ed up...

MHRA approval for home use is a different process. That relies on PHE Porton Down review and approval. As far as I am aware, Avacta/Mologic haven't got as far as submitting the CE marked test to that process (following the predecessor Avacta test having failed).

*No... what I am saying is that you can't say something is 'significant' or not based purely on whether or not it is RNSed.