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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”
I'm hoping each Avacta LFD is stamped 'Affimers Inside'
In Introduction to the Prof Tim Peto Jan 15 pre-print posted earlier by PL75 it clearly states that the group of LFD's tested were first generation. Surely the use of affimers in such a test would merit a more respectful moniker? Would we really expect the Avacta LFD to have been included?
"To date, many manufacturers have developed first-generation rapid SARS-CoV-2 antigen-detecting LFDs... Here, we report the diagnostic performance of first-generation SARS-CoV-2 antigen-detecting LFD for rapid 94 point-of-care (POC) testing."
Part 2 ...
In November, the Food and Drug Administration approved Kantaro’s test for emergency use. But the approval comes with a qualification: the test, called COVID-SeroKlir, is considered semi-quantitative.
The FDA appears to be waiting for the international standard to be set before declaring tests fully quantitative, Barrington said. However, European regulators are not waiting. They cleared COVID-SeroKlir for use as a fully quantitative test.
Other tests also have won clearance. One was developed by drug maker Roche, based in Basel, Switzerland. Its test – the Elecsys Anti-SARS-CoV-2 S – is being used in a partnership with Covid-19 vaccine maker Moderna to trace antibody responses in vaccine-trial participants. Like Kantaro’s, the Roche test was approved for emergency use as a semi-quantitative test.
Some are looking beyond Covid-19 to other infections.
A group of researchers from Linnaeus University and bioanalysis company Attana, both in Sweden, is developing a quantitative test for Covid-19, as well as the bacteria that causes tetanus.
“Our vision is a general diagnostics platform that is relevant not just at present, during the ongoing pandemic, but one that will also serve a greater, broader purpose in the future” Teodor Aastrup, Attana’s CEO, said in a statement.
I've not followed the antibody side of testing very much ..ODX, Abingdon ... But I have a holding in RENX - Renalytix that is in a joint venture with Mount Sinai Health Systems which has developed quantitative antibody testing. This seems far more relevant than a simple present / absent test, as this article explains:
Next-gen antibody tests promise more answers to Covid-19 questions
The new tests can open a window into the duration of immunity and to the antibody levels needed to sustain it. But first, a universal standard is needed to ensure results are comparable between tests.
By JOEL BERG MedCity News Jan 11, 2021
The next generation of antibody testing for Covid-19 is beginning to take shape.
Initial tests determined whether someone had or did not have antibodies to the virus’s signature spike protein. A new crop promises to quantify the antibodies, an advance that could be crucial as researchers seek to understand longer-term immunity from the virus, whether acquired through vaccines or natural infection. But that is not the only question out there.
“There’s still a lot to be learned,” said Michael Haydock, a senior director at Informa Pharma Intelligence in London.
For example, he said, researchers don’t know if there is a threshold number of antibodies a person needs to maintain immunity, Haydock said. Quantitative tests could help pinpoint a threshold and track whether antibodies fall below it, potentially necessitating a booster vaccine.
“Measuring that is going to be very important,” Haydock said in a phone interview. Tests also may be able to quantify differences in immune response based on age, race and other factors.
In addition, quantitative tests can be used to assess people who have recovered from Covid-19 and want to donate plasma for use in convalescent plasma therapy, a treatment for the virus. Researchers also may be interested in understanding the response to Covid-19 vaccines among those who are already on therapies that modify their immune systems.
“That’s the nature of this pandemic, that you’re trying to move forward when you have more questions than you have answers. Antibody testing can help answer those questions,” said Sara Barrington, chief commercial officer for Kantaro Biosciences.
The New York-based company offers a quantitative antibody test for Covid-19 using technology developed at Mount Sinai Health System early in the pandemic. Kantaro is a joint venture between Mount Sinai and RenalytixAI, a diagnostics company based in the United Kingdom.
Complicating the issue is the lack of an agreed-upon standard for measuring antibodies. However, clarity is on the horizon.
The World Health Organization is expected to set standards soon, Barrington said in a phone interview.
“With an international standard, you’d be able to compare the results across different tests,” said Erik Lium, Kantaro’s chairman and the chief commercial innovation officer at Mount Sinai.
continued ......
On the Andrew Marr show tomorrow morning
Thanks Matml74. Its unfortunate that PCR became the gold standard so quickly but perhaps not surprising given the scale of the testing problem thrown up by the pandemic. AVCT's BAMS alternative has the making of a far superior alternative.