Member Info for benbenbenben

I said this the other day, but when Avacta updated it’s website wrt variants, it listed the Delta variant as being done on direct patient samples, whereas the others were with inactivated virus.

Given that previously, samples were coming from PHE, the prevalence of Delta here and the routine genomic sequencing of samples in the UK (how else do you know if it’s Delta?), my hunch is that this was done in a UK hospital - potentially as part of a larger validation study.

That’s one way of reading it Pigster, though I don’t think you can definitively conclude that.

The other is that they are continuing to field test the device using real world samples - further enlarging the data set from Spain.

Given the EU and UK will soon require a minimum sample size, even a few additional samples will push us over the threshold. Though as they’ve said in the Q&A released today they are widening the data set, personally I think a larger clinical evaluation is taking place somewhere.

Somewhat tangential but a few months ago, a director of Mologic referred to Avacta's LFT as "His" test in a conversation with a friend of mine, as Mologic effectively rebuilt the whole device from scratch. Presumably then, the advantages of Affimers are well understood at the top of the company.

Looks like shes about to...

Sagetrade, like everyone I have given up guessing what's going on, but this is copy/paste from Omega's RNS - I put it here because the information is relevant to people here.

There is plenty of evidence the government are pursuing development of domestic tests.

Whether that will be us or not I don't know any more - Al has made clear the focus is now on Europe and that discussions are 'ongoing and slow'.

And yes my theory on the government buying the lot hasn't transpired (yet) - but it was based on by-and-large publicly accessible information coupled with what my mate at the Financial Times was giving me from their work on diagnostics. And if you can't discuss a share on a share discussion board then...

Timster - I thought I that at first, but then we’re not transferring from development at this point as GAD are now manufacturing at scale.

Plus we know from Al we are still in the process, PHE have supported variant confirmation, Gov say they are talking to multiple test developers, etc...

@Wiggly - given members of this board managed to attend the lay user study, we know Medusa are fairly well advanced in gaining self-test approval.

As to other UK based tests, I don’t know if any have self-test approval?

“Outlook
Despite the delay in our ability to commence supplies under the DHSC supply contract, we remain confident that the new financial year will be transformational for the Group.

COVID-19 - we expect a successful conclusion to discussions with DHSC that will see us utilising the capacity for both our own equipment and the Government-loaned equipment, which will be further utilised with expected demand for our VISITECT® lateral flow COVID-19 antigen test, especially once we gain approvals for the self-test version and the Emergency Use Authorisation from the US FDA.”

A bit more detail:

“ The focus of the market currently is on antigen testing as a key tool to manage the pandemic and we were pleased to announce the signing of a contract with the Department of Health and Social Care ("DHSC") in contemplation of manufacturing selected tests on behalf of DHSC to meet the UK Government's desire for UK-manufactured product. We had hoped that the Mologic test would be chosen by the DHSC as a UK-developed test to be made by us as UK manufacturers, however the contract itself is test agnostic and we are prepared to manufacture whichever test is chosen. The ability to supply tests that are produced within the UK remains a key priority for DHSC and to that end they have facilitated discussions with other potential partner companies with lateral flow antigen tests that have now been approved by the DHSC and also have self-test approval. We have already concluded technical diligence with these parties and we are confident that the transfer time can be expedited given that they have tests already working at scale, rather than transferring straight from development.

In addition, we are also pleased that we have been able to CE mark our own branded VISITECT® lateral flow COVID-19 antigen test for professional use, and we are advancing our plans to achieve approval for home-use as well. To achieve self-test we have been working hard in the background to simplify the sample collection method to ensure consistent results when used by a non-professional. Whilst the cassette itself has not changed, we have looked at the sample handling process and sourced a supplier capable of volume manufacture of pre-filled tubes with our buffer formulation and have performed successful internal studies to confirm this new collection method produces the same performance as the professional test. As a result of this work, we are confident that we can achieve self-test approval and we are now in the process of confirming this externally, which is a requirement of the CE marking process.

Whilst we had hoped to start the utilisation study for home-use earlier, we had to expand the scope of the study to meet additional regulatory requirements, however I am pleased to report that the study has now commenced. We plan to submit the data from the study to our European Notified Body by the end of the month and we are working with them to explore how we can fast track approval. Once we receive approval we have high expectations that our distribution partners will be very successful in the market place with one of the first UK-developed and manufactured self-test products to enter the market.

We are also mindful that once we have self-test approval the VISITECT COVID-19 Antigen test would potentially be available for future DHSC purchase as a UK-developed and UK-made rapid point-of-care test for active COVID-19.”

Omega have their final results out today - this passage is relevant to us (taken from this AMs RNS) as it suggests the supply of a sovereign test is still very much on:

“We believe that the ability to supply tests that are produced within the UK remains a key priority for the Department of Health and Social Care ("DHSC") and to that end the DHSC had facilitated initial commercial discussions between Omega and potential partner companies with lateral flow antigen tests to potentially provide UK manufacturing services. Currently this selection process by the DHSC is taking longer than we originally expected and we are waiting for confirmation on which test we will be required to manufacture. While we are not in control of this process, we remain in regular dialogue with the DHSC to provide manufacturing capacity for COVID-19 lateral flow antigen tests, utilising the key pieces of manufacturing equipment loaned by the UK Government for that purpose.”

Good find - and we know from repeated company statements we are one of the test developers in question.

To me, I find it inconceivable that having invested heavily in domestic LFT infrastructure, this will not be used to keep the economy moving over the coming months. Clearly, this process is still ongoing...

Yawn

Unlikely Mr A, the give away is in Calibre's job description - "Distributor"

Given Myles McNulty has said on twitter he's ordered, paid and got a date for dispatch in July, the inference from your August quote would be that it's selling well!! :)

Here you are Tyche - well worth re-reading when it’s volatile like this:

https://www.trinitydelta.org/wp-content/uploads/2021/06/Avacta-Initiation-210629.pdf

Pretty much every public health professional is pessimistic - globally - as the current approach is completely moronic. I’m sick to death of the restrictions like everyone else, but the current approach reminds me of the closing scenes of “Chernobyl” - where the physicists explains how all controls are removed until the thing explodes. More transmission = more mutations. Allowing the virus to uncontrollably bounce against a partially vaccinated population dramatically increases the risk of vaccine escape. I don’t think this policy will last long as fear grows TBH

https://www.theguardian.com/commentisfree/2021/jul/07/living-with-the-virus-uk-vaccinated-covid-cases

"The £22bn NHS test-and-trace system risks being overwhelmed by surging Covid infections after the planned wholesale lifting of restrictions in England this month, a leading academic has warned.

Jon Deeks, a professor of biostatistics at the University of Birmingham, said at least 660,000 gold-standard PCR tests are likely to be needed each day to discover 100,000 daily infections this summer – the number forewarned by the health secretary, Sajid Javid, after the government announced plans to drop restrictions from 19 July.

This level of testing is almost three times the current rate in the UK, more than double the highest volume achieved at any point during the pandemic, and at the peak of the system’s theoretical laboratory capacity calculated this spring by the National Audit Office (NAO)."

Maybe the idiots will start using that domestic LFT infrastructure after all...

https://www.theguardian.com/world/2021/jul/08/lifting-covid-rules-in-england-will-overwhelm-testing-capacity

Avacta's clinical trials don't need to prove efficacy, only safety - the drug is already known to be efficacious and is a front-line treatment. The improved safety profile is the point of the the entire PreCision platform. First data readout's are expected at the end of this year.

They've also signed an array of new partnership deals in addition to expansion of existing programs, with the potential for significant long-term royalties and near term milestone payments.

The company is fully funded until 2023 and is a radically different proposition to what it was twelve months ago.

In addition, it now has the prospect of generating revenues through a best-in-class diagnostic during a period of extreme demand. Yes, commercialisation is taking longer than anticipated, but even modest sales will be transformative for the company.

I did not - I ordered a copy, waited a month for it to arrive and the guy cancelled on me and doubled the price!

It is, however, high on my list of books to purchase - so I will make a note of p184 and let you know my thoughts.

Thank you for the recommendation regardless!

One of the highest death rates per capita in the world, while achieving the worst economic damage despite the some of the most prolonged and severe lock-down measures in the Europe, suggest to me the statement "the government is out of its depth" has a strong basis in fact, especially when led by a serial liar who proclaimed "let the bodies stack up".

The only aspect which hasn't been a disaster has been the vaccine roll out, principally because it was carried out by the public sector and overseen by actual public health experts, not some gang of £5,000 p/h management consultants brought in to oversee the palm greasing.

For all the criticism of Al and his timescales, it seems abundantly clear to me the primary route to market was through these charlatans, who proceeded to lead him - and the entire British diagnostics industry - up the garden path, while they handed out contracts to their donors/neighbours/siblings/pub landlords in exchange for little brown envelopes.

It's clear something very untoward has gone on here - and reasoned view of Avacta should take this into account.