Member Info for Fardistanthills

I noted your interesting comment on the use of frozen samples at the time doze, and I too suspect saliva sampling could eventually be proven up.

I thought the categorical statement that the saliva-based rapid antigen test from Avacta had not been evaluated at PD was most interesting. Sounds - as has been discussed here many times - this was a pivotal issue. For whatever reason, whilst AVCT clearly put much store by it, it seems to have been rejected out of hand - Prof Cheeseburger didn't like it, too out of line with what had become standard sampling practice, unhygienic, whatever?

You describe it exactly - the use of the term 'artificial' simply puts into lay terms the first step in the approval/certification chain.

Maybe someone who has a Facebook account should stick a question in the comments box below the Huff article along the lines:

Just for clarity, when you say "the latest updated version has shown excellent preliminary results and is currently being assessed" is this the "latest updated version" of a saliva test?

On the one hand the extent to which Avacta is able to firmly guide Stifel on LFT sales is no greater than the disclosures they've so far made to the market, which for whatever reason -NDA's etc. - is pretty much zilch.
On the other hand there have been statements such as those made by AS in the Share Buyer's article last October:
"In the UK alone, the demand for antigen testing in the community could be as high as 100 million tests per month in the medium-term. Through our partnerships, we are looking to supply beyond just the UK market."
I guess Stifel have to be conservative.

Monkswood posted this just after the the 16th Feb RNS announcing the initial LFT evaluation, when some where querying why the RNS did not mention whether the results were obtained by AN or saliva sampling:
"Talk of sampling method is irrelevant, they do not specify this as it is about a comparison of the LFT with PCR CT."
I think what he said sounds right

OK, thanks.

doze, you say below
... 30 samples which may have been selected from a batch of 1000 pcr tests yielding 30 positives with 15 in the 22-25 and 15 in the 26. Only one of the 22-25 came negative, all 15 of the 26 were positive. But how pointless is the exercise if samples were from a cohort of 1000 whittled down to 30?
Where does the 1000 batch size come from please?

Cytiva aren't a manufacturer - just as Avacta aren't! But I bet between them you could find one or two - over he pond that is. We'll see. Lots to come and to wait for.

Me too - I've done it before and it has rarely come off! Note to myself, never again but be patient with Avacta, this is a fantastic start with much further to go. Well done AS and all who are working on it.

Surely Cytiva could still be playing a big part in all of this? Not least no one has said they're not!

Don’t forget last September Danaher announced that it would invest $500 million and hire 1,000 people over the next five years in an expansion of its Cytiva global manufacturing capacity with the CEO saying they had to be ready "as COVID-19 sparks demand" for its products in business areas including… process chromatography hardware and consumables… diagnostic tests… lateral flow assays... etc. etc.

And in keeping with the general radio silence, alleged NDAs, etc. - seemingly observed by all involved - for months Cytiva too have said nothing about any role they may have in future UK device production. Though I am not aware they manufacture the end IVDs, they are a big player in 'strip' production - as was explained in the last mention I have heard made of them - in the Q&A after the September Interims. And the fact AS chose this as the first thing to answer surely tells us Cytiva could well still be a key partner? This is how he explained it all fitting together:

Q1: "... please give an explanation of Cytiva’s role in the manufacture of the rapid antigen test.”
Answer: “That’s a good question, which allows me to clarify… So Cytiva are a materials company, they manufacture the materials to make the strip … they supply the finished nitrocellulose strip, not the finished IVD. So the manufacturers who supply the finished IVD are the likes of BBI Solutions and Abingdon Health… It’s really a process of raw materials from Cytiva and Avacta… So we have partners who do the strip manufacturing, and partners who do what’s called the kitting, who put the kits together and then obviously the logistics of shipping those out”

Obviously I could be totally wrong. I often am!

But Cytiva would be a great US partner, given the US will on the one hand - I hope - be impressed by Avacta's affimer IVD 'reagent' and on the other hand will want a US company to be seen leading development over there for them.

PAHOO - We will never know the fact until after the RNS, if you want to get in early rumour is an important part of the process.

Very true. Jimmy Goldsmith - Goldenballs of Private Eye infamy - use to say once you see a bandwagon rolling, it's too late - or words to that effect!

I thought the 06.55 post this morning from ab8dct was really interesting - many thanks. Quoting from it

- The Affimer binds to the spike protein on the outside of the virus the n protein is on the inside.
- N protein LFDs will only work if you scrape the back of your tonsils and lower brain - not the best! This is because the n protein will be released by the infected cells and tissue at this point so you need to collect it here. I don’t think there is virus lysis solution in the LFD, but happy to be told otherwise. Other substrates such as saliva or lower nasal collections wouldn’t work that well - so what’s needed for home testing is something that can recognise a protein on the outside of the virus.
- This is where the Affimer comes in. Not only can it be used for brain swabs but also for lower nasal or potentially spit. Much easier sampling for the general public and much more likely to be approved for home testing as well as professional testing.

So April 2020 Avacta saw the ability to affimers to bind to the more accessible outer part of the virus as an advantage in terms of how a 'sample' was obtained i.e. much less intrusively - saliva or anterior nasal rather than tickling the brain. And this is the reason for the route they took.

I am sure those better versed in these things will have already cottoned on, but it has helped my understanding - so thanks again ab8dct

Diplomat65, you said below ... stripping away packaging, buffer solution, pipettes etc assume £5 for the complete cassette. This product is a result of Avacta (Affimer) BBI (nitrocellulose strip?) and Abingdon cassette assembly (?) each wanting their cost recovered plus margin.

That's not actually what the partners all do. AS explained it quite clearly in the Q & A after the Interims last September:

Q1: "... please give an explanation of Cytiva’s role in the manufacture of the rapid antigen test.”

Answer: “That’s a good question, which allows me to clarify… So Cytiva are a materials company, they manufacture the materials to make the strip … they supply the finished nitrocellulose strip, not the finished IVD. So the manufacturers who supply the finished IVD are the likes of BBI Solutions and Abingdon Health… It’s really a process of raw materials from Cytiva and Avacta… So we have partners who do the strip manufacturing, and partners who do what’s called the kitting, who put the kits together and then obviously the logistics of shipping those out”

Given the good relationship the UK Government has with Innova - not to mention the good business we've put their way - maybe Innova could be persuaded to switch to using Affimers in their LFD? If they wish to continue in partnership with us of course. Which they might just.

We shouldn't forget what Avacta and Pro. Bhella of Glasgow University Centre for Virus Research had to say in last year's 18th June RNS. Some snippets making much of the therapeutic possibilities, which at the time sounded extremely encouraging:

Update on Affimer(R) Therapy for COVID-19 Infection

... collaborative work with the Centre for Virus Research at the University of Glasgow has shown that Affimer reagents which bind to the SARS-COV-2 virus spike protein prevent infection of human cells by a SARS-COV-2 model virus and therefore provide a potential therapy for COVID-19 infection

... Avacta has now successfully completed the initial phase of a collaboration with Professor David Bhella at the University of Glasgow showing that these "neutralising" Affimer reagents prevent a SARS-COV-2 model virus from entering human cells and therefore provide a potential therapy for COVID-19.

... Affimer reagents have key benefits compared with antibodies as virus neutralising therapies: Their small size and high solubility means that a much higher concentration of Affimer molecules can be used in the drug formulation to more effectively block the spike proteins on each virus particle and better protect the patient; bispecific and trispecific Affimer neutralising therapies that bind to more than one part of the spike protein could ensure the effectiveness of the neutralising therapy even if the virus' spike protein mutates.

... There is ongoing significant investment by large pharmaceutical companies such as AstraZeneca, GSK, Boehringer Ingelheim and others to develop neutralising therapies for COVID-19.

... The infectivity assays that we have carried out with the Affimer reagents have gone very well and they show that there are a number of them that are potent inhibitors of a SARS-COV-2 model virus entry into human cells. Given the excellent performance of these novel reagents in the assays, and the other benefits of Affimer reagents, there should be considerable interest from potential partners in developing them as a therapy for COVID-19."

And from the Interims RNS 28th Sept:

... Post-period end, the Group announced an expansion of its collaboration and license agreement with Daewoong and AffyXell to develop stem cell treatments incorporating Avacta's neutralising Affimer molecules for the treatment of seriously ill patients with COVID-19 and to also prepare to rapidly develop similar therapies for future global pandemics.

Interesting link, thanks PL75. Presumably this taken from it suggests there is serious intent in the form of product development through to marketing, not just more clinical work:-

The capital raised during a series A is usually intended to capitalize the company for 6 months to 2 years as it develops its products, performs initial marketing and branding, hires its initial employees, and otherwise undertakes early stage business operations

Nice indeed. If a committee of the great and the good on here were asked to come up with a review of the state of play of lateral flow antigen testing in the UK this is what they would have produced!

No mention of Covid today’s RNS but the Daewoong CEO does talk about “meaningful treatment options to patients suffering from refractory diseases.” Which got me trying to join some dots - i.e. Covid ramping!

I’m not a medico but presumably long Covid is a refractory disease? As Agent B pointed out earlier, in the 29th July RNS there was much talk of Covid:

The expansion of the agreement between Avacta, Daewoong Pharmaceutical and AffyXell announced today extends the scope of the partnership to include Affimer molecules that target viruses, such as coronaviruses, in order to develop therapies that repair the lung damage caused by COVID-19 whilst also producing neutralising Affimer molecules to prevent the progression of the disease.

AffyXell will engineer mesenchymal stem cells to express SARS-COV-2 neutralising Affimer molecules in order to develop treatments for seriously ill COVID-19 patients, and will also prepare for rapid development of next-generation stem cell therapies for future infectious respiratory disease outbreaks.

If it helps, he role of Cytiva, Avacta, BBI, Abingdon were explained in the Interims Q & A.

Q1: "... please give an explanation of Cytiva’s role in the manufacture of the rapid antigen test.”

Answer: “That’s a good question, which allows me to clarify… So Cytiva are a materials company, they manufacture the materials to make the strip … they supply the finished nitrocellulose strip, not the finished IVD. So the manufacturers who supply the finished IVD are the likes of BBI Solutions and Abingdon Health… It’s really a process of raw materials from Cytiva and Avacta… So we have partners who do the strip manufacturing, and partners who do what’s called the kitting, who put the kits together and then obviously the logistics of shipping those out”