Member Info for Fardistanthills

Unprecedented - things have evolved rapidly recently, pivoting in favour of self testing with the widely discredited Innova tests are being delivered in volume for home use. And yet AVCT is apparently at present are validating for professional use only. Something does not add up. Can you enlighten!

Thx - so definition of professional use is essentially the same for both UK & EU.

In the UK professional use seems allow for a very broad range of people to be trained up to supervise testing - volunteers at schools, etc, etc. Not being strictly restricted to medical professional use provides a sizeable market before a manufacturer gets into seeking self-test approval. Does anyone know whether the EU is similarly 'lax' in its definition of professional use?

Very well said Doggy100.

It often gets to the point where posters who make some really useful contributions, regularly digging out interesting and valuable stuff, on the other hand are responding so much to the sealions that they become almost indistinguishable from the real pains in the neck.

You calling my wife not normal or healthy Baffyman?

Its called a touch of the Stanley Unwins!

But you are right - it was a very interesting point - I hadn't clocked either that the only Affimers AVCT will make will be for the Diagnostics business and that Affimers to be made for Therapeutics side would be produced under contract by an outside manufacturer. So AVCT itself will not want to set itself up to do this since much more stringent process control conditions would be needed - a different standard of manufacturing would be required. Interesting implications maybe?

It makes me wonder whether this means the two sides of the business are therefore much more readily separable with the Diagnostics side licensed to use Affimer solely for in vivo diagnostics, paying a licence fee, royalties whatever and producing their own diagnostics Affimers.

It would presumably also make it easier for a pharma type acquirer, allowing them to buy the whole of AVCT to realise its therapeutics potential and then offload the diagnostics arm?

I'm sure someone will shoot me down if I'm wrong!

Not that I would want this to happen until much more of the pharma side of AVCT has been realised.

Affi Days

Try the AVCT web pages - news listing - at least its factual!

Q for anyone who is into charting? Our 50 day MA seems to have risen through the 200 day, which I think is itself just about rising. or maybe level ish. Does this count as one of those mysterious golden crosses, reputed to be a sign of untold riches to come?

Thanks all for the latest on DHSC LFT tendering and specification. SC, the spec doc is fascinating – what you might call a rose tinted spec? Just my observations for what they're worth

It starts by describing the SARS-CoV-2 antigen tests they have seen as either spike protein ‘S’ or nucleocapsid ‘N’ – a Freudian slip? - n before s in my alphabet!

There is emphasis on DHSC not wanting to foreclose the possibility that innovative and effective forms of tests may qualifying later, so plenty of scope for combining Avacta's spike antigen test with Mologic's nucleocapsid antigen-based technology,

It confirms saliva still in the frame - test kit may contain, depending on collection method, a sterile swab or Saliva collection vessel and possibly a funnel for saliva samples.

“Test & Trace requires individual cassettes being uniquely identifiable in order to link the Test to an individual user - ensuring this linkage is imperative for clinical governance purposes and cannot be achieved without a Test & Trace specific, customised identifier format.” This to my mind seems to show the new £8Bn tender is something more than the procurement of just another bunch of LFDs but rather part of a process of integrating point of use testing into Test & Trace? I’m sure others here will be able to fathom this out better than I can.

Reiterates not seeking to purchase tests for which the only specimen collection method specified is nasopharyngeal or oropharyngeal (or both) and uses diagrams to emphasise this – for the avoidance of doubt.

Requires tests “which have been demonstrated to be effective in the testing of (and ideally would have an explicit a statement in the IFU which confirms that they are suitable for testing of) asymptomatic individuals.”

Must be capable of and legally permitted for use as a Self-Test and passed Phase 3A Validation.

The section stating the “objective of the test will be critically undermined if established and emerging strains (variants) of SARS-CoV-2 are not capable of being detected by these LFTs.”
Surely from what AS has hinted this must be a massive plus for Avacta’s S protein, affimer based?

It goes on to say testing is underway at PH “to test the ‘sensitivity’ of Tests in the detection of the UK variant (also called 'Kent Strain', 20I/501Y.V1, VOC 202012/01, or B.1.1.7) and the South African variant (also called 20H/501Y.V2 or B.1.351). It is anticipated that Phase VOC (Variant of Concern) Validation will shortly also include ‘sensitivity’ testing against the Brazil variant (P.1), and may in future include other variants.

Thanks again for posting SC

It does sound interesting! A "Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients"? Will this be a first safety assessment of Affimers? I don't really have much of a clue! To help me understand a bit as to why it might sound interesting I dug back to the recent 1st Feb AffyXell financing RNS. Some quotes from it :

"AffyXell was established in January 2020 by Avacta and Daewoong as a Joint Venture to develop novel mesenchymal stem cell (MSC) therapies. AffyXell is combining Avacta's Affimer platform with Daewoong's MSC platform such that the stem cells are genetically modified to produce and secrete therapeutic Affimer proteins in situ in the patient. The Affimer proteins are designed to enhance the therapeutic effects of the MSC creating a novel, next generation cell therapy platform...

Sengho Jeon, Chief Executive Officer of Daewoong Pharmaceutical and AffyXell Therapeutics, commented:

... We look forward to launching new class of MSC therapies that overcome the limitations of existing antibodies and cells and provide meaningful treatment options to patients suffering from refractory diseases."

I remember wondering at the time would refractory diseases include long Covid.

And to what extent are Affimers involved.

Certainly interesting, thanks Richbob

Thanks alextak. It is amazing how alarms with respect to alleged competitors keep coming around and how quickly such useful responses from the likes of Chiron can be forgotten!

Totally out of my depth here but if it helps, this was posted a while back?

Trade mark number UK00003519801
Status Registered
Trade mark AffiDX
Dates
Filing date 06 August 2020
Date of entry in register 20 November 2020
Renewal date 06 August 2030
Owner(s) name Avacta Limited
Unit 20, Ash Way, Thorp Arch Estate, Wetherby, LS23 7FA, United Kingdom

Vegas, Mina articles are always well argued. He seems a very level, well researched guy - so as you say he probably needs little introduction to AVACT. Being an outsider it is always easy to underestimate how much those immersed in a technology/academic specialism connect with one another.

jdt - is Mina aware of AVCT's potential - its Covid LFT performance and supply ambitions? I guess its quite likely. He would certainly relate well to what AS said in his latest Vox Markets interview!

Doze - "Most expect the Mologic application to pass clinical validation and go on to a field trial while BBI and Abingdon will go straight to market when they(AVCT branded) have proved manufacturing to ISO 13458 if the Mologic test has passed its field trials as it is standard equipment for the sovereign test."

And just to spell it out, since the Mologic initial version will be entitled to use their CE accreditation, then presumably all the very first production batches of the AVCT branded lateral flow rapid tests going out will be stamped with a CE mark - which would not be the case if AVCT had to wait for its own accreditation. This has always been my understanding anyway.

PS fantastic update today, still re-reading and re-reading!

Every time I add one to my filter box - one so far today - I now think to myself, another for my sealion colony.

For those that are a bit slow like me, I have just realised that the full Business Update is very full indeed! Quite a read - I am now combing through it on Avacta's web site. Surely its unusually long for a post year end Business Update and I wonder if this signifies anything? Other than nailing down exactly were things are up to.

Vostikc thanks, interesting. BJ mentioned this several times yesterday, and today, and it was discussed at lunchtime on R4 - World at One. In a way it was also referenced way back in AVCT's 23rd Nov RNS - in terms of 'use cases' - bringing a test to market "to suit a range of use cases." It must be frustrating for AVCT if it cannot get a clear idea from government as to how a rapid test would be used. On the other hand any such government indecision is helpfully providing some breathing space for completion of full clinical validation and CE marking. Which is good!

Mowz - I wouldn't worry at all about PD using 'artificial' (or spiked) samples. This would I am sure be perfectly normal practice - and has been explained this morning on a thread called "Excellent analytical sensitivity and specificity" Many years ago I worked as an analytical chemist and as an initial step in proving up any new method of analysis, artificial or spiked samples would always be used. It allows the early assessment of a new test to be done under conditions which eliminate all the real world noise that will subsequently be encountered when samples are taken 'in the field.' In the case of a medical diagnostic test such as AVCT's LFD these 'in the field' samples are the clinical samples that are now undergoing what today's RNS describes as 'full clinical validation with a larger number of patient samples in order to obtain a CE mark for the test for professional use'. Reference to the use of 'artificial' samples by PD was to the initial evaluation, which would have deliberately avoided the use of real clinical samples - in order to eliminate real world variables and so as to focus on pure analytical performance. Hope that helps.