Member Info for Muck165

An interesting link within the government piece is

https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overview#fn:2

Gives a thorough overview of the whole program and also figures at the end detailing the number of products in the pipeline and at what stage. Am assuming that BAMS is one of the 17 currently being validated/evaluated.

@chiron - interesting and thanks for posting. Just wondering if you had thoughts on the remainder of the article, and in particular how/if the following might affect BAMS?

“Downing Street last night said it had signed a contract with Southampton-based diagnostic firm Primerdesign for up to 300 polymerase chain reaction (PCR) testing devices, which will be placed in NHS hospitals from next month and will be able to process around 60,000 samples a day.“

From a few days ago so apologies if posted before - basically a question posed to Helen Whately, Minister for care at DHSC, about whether people will have to pay for moonshot tests. She evaded the question but did reconfirm the “huge amount of resource and investment going into developing new technologies for testing, easier testing, quicker tests and tests that can be done at greater scale.” See from about 1.04 till the end.

https://twitter.com/justinmadders/status/1313493724077395969

Your’re welcome

Well, from the Sona boards I read it seems investors are really frustrated by delays at HC and FDA in approving their test, and angry that both have approved what they perceive to be an inferior Abbott test.

Health Canada published this today;

https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/use-rapid-antigen-detection-tests.html

I thought it was swell written piece that outlined all of the various Issues that they, and no doubt other government health agencies around the world, will be considering behind the scenes before committing to mass antigen LFT testing. I think the U.K. govt certainly are, hence Condor.

One thing that did confuse me was the suggestion in Q4 in the Key Scientific Considerations section that; “If an antigen test is used with saliva, there are 2 sensitivity costs being paid and this impact must be evaluated together to inform potential for use“ - I had thought that saliva was considered the more accurate sampling method? Any views anyone?

Have just finished listening live to the latest of these events held this PM. (anyone can do that btw).

TBH I did fall asleep for a lot of it, but was awake right at the end when the FDA were asked directly whether or not they have had any EUA applications for an “at home” molecular or antigen test. The FDA guy began to respond quite cagily about what he could or couldn’t say, then explained that he gets daily updates on this as a top priority, and then simply confirmed that the FDA have not as yet Received such an application.

Whilst that might have been his final answer, the way he answered it spoke volumes and it seemed clear to me that lots of conversations are likely going on behind the scenes preparatory to actual application(s)



The transcript should be available pretty soon, which I’ll post for those interested.

The latest published FDA round table transcript is here, for anyone interested. It’s dated 23 Sept, although there was another round table event today (transcript yet to be published)

https://www.fda.gov/media/142511/download

Of note are the clearly stated FDA priorities (page 3)

“ There remains a robust interest in pooling and in particular kit manufacturers who have pooling submissions that would allow those kit users in the labs that use that kit to immediately pool with minimal work and perhaps no bench work for their own lab. That obviously greatly amplifies our efforts around trying to promote the opportunities for pooling. So those would be priority.
And then point of care tests, especially those that are molecular in antigen remain high priorities. As to those that help us to expand testing further and that includes home collection, and home testing, especially for molecular diagnostics and antigen testing.”

Avacta can help with these I think..!

It seems to me that the govt have ordered some of the RTC antibody test now in order to better understand how the virus spread and how many of us might have had it.

But will the test really do that?

I only ask because, at least from what I’ve read, antibody levels are believed to wane and may even disappear within 3-4 months of the infection, so it’s entirely possible that those who had the virus in the first wave might be missed by the test now. Going forwards, it seems to me the best way of tracking spread and infection numbers will be mass antigen testing.

Probably a highly ignorant post, but it has been puzzling me.

No worries @sharesgonesouth! I’ve not seen a link yet and don’t even know if there is a recording to view.

Thanks for responding so comprehensively Seagull - appreciated!

@sharesgonesouth - many thanks but I was looking for a recording of the Stifel Q&A from today. Do you have that at all? Thx

Does anyone know if there a recording of this Q&A and, if so, could they post a link? Thx

And following on from CO, could I ask how you (Seagull) intend to reply to the two questions posed?

Great to have another industry insider on this board,

And whilst I remember, he talked about new manufacturing equipment they are buying pursuant to scale up, and notably that it’s coming from Finland. Ginolis, which I think also supply the kit to BBI, are from Finland.

One other thing - he confirmed that the Mologic/ODX agreement was non exclusive and, if I heard him correctly, mentioned that other parties like Abbott have expressed interest with Mologic. If that’s the case ( ie my hearings not off!) then is it much of a stretch to think that Abbott and/or other similar companies might be in talks with us with a view to manufacturing?

Just watched the ODX presentation - comments are;

We are lucky to have AS as a CEO
Whilst we already knew it, Colin King made clear that MOONSHOT is all about antigen not antibody testing
They are looking to expand capacity and will “flex” that to where it’s most needed.
They have had talks with us
The Mologic antigen test is still in development and is still undergoing validation before tech transfer, which we already know can take a while!. He reckons Mologic test available by Xmas

Great post - thanks Ben

@benbenben - I wonder about this too. I see you posted on the ODX board to say CIGA are now selling the ODX antibody test direct, as are other distributors. It seems that all started about the beginning of Oct after, as I understand it, some agreement between the RTC and the govt may have lapsed (may be very wrong on that point). Do you think it might be that anticipated govt orders might not be forthcoming for the RTC, hence why we already have Abingdon and BBI, and have had discussions with ODX? Seems to make sense to me given the shift from antibody to antigen tests with Moonshot.

“Less than half the UK population can expect to be vaccinated against coronavirus, the head of the government’s vaccine task force has said in an attempt to clear up the public’s “misguided” perception of the programme’s aim.

Kate Bingham told the Financial Times that vaccinating everyone in the country was “not going to happen”, adding: “We just need to vaccinate everyone at risk.”

Her comments come as Boris Johnson on Sunday warned that the country was in for a “bumpy” winter. Calling himself a “freedom-loving Tory”, he urged Britons to live “fearlessly but with common sense”.

https://www.ft.com/content/d2e00128-7889-4d5d-84a3-43e51355a751?shareType=nongift

Looks like testing needs will be around fo a while