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With all due respect and I really do not mean offence here, but in my opinion you are not giving the company enough time to breathe on this. This a new product that has to go through regulatory hoops, as will all other tests that compete with it in the future.

You are underestimating the timescales involved to achieve regulatory approvals in the regions where GDR's test can gain the most traction.

Focusing in on 1 update which comes just 7 weeks after product launch, is for me too concentrated, be it that it has worth in terms of direction to date.

This is why the demand question is so important here. The acknowledgement that demand for high quality easy to use PCR testing, will be a longer term market, allows GDR the time to implement a more thorough regulatory plan and places timescales in a broader context. There appears to be some belief that the market opportunity is being somehow missed.

Whilst there is of course a need for urgency to ensure the hard work to date has not been wasted and that revenues are indeed maximised, it is not a race against Covid being there because as i said earlier, that is pretty much a given unless Covid blows itself out. People just aren't disciplined enough to prevent it. Plus whilst a vaccine will undoubtedly come to market at some point, its chances of being either good enough to create herd immunity or indeed, supplied to all lower to middle income countries in a fair manner, are extremely low.

All of that said, GDR sales to date may still disappoint some or the time to implement may take longer than anticipated. Nobody knows until the update come out, which has clearly been signposted /thank you GDR) and at the very least it is worth waiting for.

The key part of the actual update when it comes, will be the expected roll outs for those markets where GDR can really excel but even then, it will take time to gain traction there. Hence why progress can only really be judged at c. 6 months in but nobody wants to hear that do they?

@ThePunter1

Is covid going away? NO.
Are the percentage chances of GDRs gold standard PCR test high? YES.

That is my opinion, which is as worthwhile as yours or anyone else's on these BBs.

I find the lack of support and positivity for GDR on this BB, given what it has achieved with its test development, quite unbelievable but then not everyone is in GDRs corner, are they?

That's not to say that GDR have a free ride. They still have things to prove but they are getting very little slack, which simply isn't fair.

Thank you Ophidian. No it was not a trick question. I have looked everywhere for references from AVCT and found none to date.

The only guidance is that it is like a pregnancy test, which involves urinating on a stick. So it implies the stick sample but it isn't a given, until it is announced. I appreciate your input on this.

@ThePunter1 It may indeed be a thinly veiled ramp but what it does help demonstrate, is that Covid is no longer a flash in the pan, which was the general consensus for the first few months of the outbreak. In fact there are still many contributors out there that base their analysis of world Covid testing sales potential, purely on what is happening in the UK.

Personally, I stopped logging the case numbers some time ago because once Covid cases started to expand in countries that are well known for having hot humid climates, it became clear that the problem is far bigger than many of us were able to concede.

The ability of Covid-19 to overcome the usual constraints of influenza, that being generally temperatures of more than 20C and humidity at 80%, then it effectively becomes a year round problem. The only proven methods for controlling outbreaks and that is what is happening here now, control, are to socially distance ourselves from one another, wear face masks and maintain higher hygiene standards, than are the norm and carry out substantial testing on a daily basis.

These measures have already proven to be too difficult, first time around, for supposedly organised and well serviced, countries such as the US. Other more successful countries such as Germany and Australia, have still witnessed local outbreaks and lock downs because getting everyone to follow the rules all of the time, is extremely difficult to achieve.

Added to this is the fact that people become complacent and the less cases that are talked about in any one country, the more likely people are to ignore the rules that prevent a further outbreak. In addition, it has become clear to most countries now that they cannot afford a full lock down and many lower to middle income countries, simply cannot afford lock downs at all. So we have moved into a management phase, which means more testing or simply suffer the consequences of failing to do so.

All of which is amplified in countries where the people are generally poorer, lacking in social care, heavily reliant on working to live and live in much closer to proximity to one another. It is these markets that GDR are focused on, be it they need time to implement.

Is it guaranteed that GDR will succeed? No. Is it guaranteed that any business will? No.

What we do is look at the percentages. In my opinion, the above criteria means that demand will be maintained at elevated levels for some time. In fact a good many poorer countries will highly likely never rid themselves of Covid and the West will probably stop caring, once its own problems are resolved and Covid is long forgotten about there.

That aside, in a market where I expect demand to remain high, easier to use gold standard tests, however new to the market they may be, for me, will succeed. Hence why I am here and will allow this to play out fully.

That applies even if a vaccine with strong efficacy comes to market.

@Ophidian Out of interest, where or what assumptions have you employed, to deduce that the AVCT test is a spit stick test?

@Spike66 Thank you fr sharing, that is most interesting.

Here is the Optigene press release for the test that is being trialed by the UK government, which is presumably the nasal/throat swab test you received.

http://www.optigene.co.uk/wp-content/uploads/2020/04/OptiGene-Press-Release.pdf

From the press release ;
" This specific and extremely sensitive test can operate directly from nasal and throat swabs to produce results in less than 20 minutes."

So it is really interesting that the trial is also testing a non swab saliva test.

Whilst we shouldn't jump to conclusions, we do know that UK government is very much aware of AVCT and the government's own press release on the Optigene trial, states that ;

"we are currently exploring the potential of other no-swab saliva-based coronavirus tests with companies, including Chronomics, Avacta, MAP Science and Oxford Nanoimaging (ONI)."

https://www.gov.uk/government/news/new-saliva-test-for-coronavirus-piloted-in-southampton

I did look at this on my twitter feed when the Guardian piece was published on 22nd June.

https://twitter.com/BigBiteNow/status/1274959152394240000?s=20

Essentially Chronomics are looking at a no swab postal service test system, which requires min. 4 days turn around.

MAP Science is looking at a mass spectrometer test option, much like the AVCT BAMS test.

Oxford Nanoimaging (ONI) are microscopy based and so are working in a supportive role (with Southamption Uni) and don't look to be producing a test of their own.

So the AVCT candidate would clearly be of most interest to UK government and by conducting this trial, clearly more information on its uses can be gleaned.

Knowing that tests are generally set up against specific sample retrieving methods (note the issues with Superdrug and the Abbot tests), then what test are being used to test these samples?

@Kaysee For what its worth, you have no need to explain yourself to me or anyone else. You are entitled to share your opinion here as much as the next guy/girl.

I didn't take your contribution to be anything other than a very solid and worthwhile opinion. These boards should be about debating everything about a company, not just what we want to individually hear.

From the how is diagnostic test performance measured video dated 23rd June ;

"as soon as we reach agreement with the manufacturing partners, we'll be able to provide more detail on the precise timeline for having product available."

From the IG interview dated 2nd July ;

"that prototype now works"

"we in the process of optimising that to get it be as sensitive as we possibly can and that'll just take a couple of weeks"

"and we are expecting to sign up manufacturing partners, very very soon."

For those that have followed the detail, AVCT have always talked about requiring multiple manufacturing partners to satisfy the expected demand.

All of that wording is associated with a company that is bringing a product to market that requires those multiple manufacturers. It is not associated with a company that is hopeful or seeing something in its prototype's performance, that leaves too much room for doubt.

Being the pragmatic chap that he is, Dr Smith would not say very very soon, if it wasn't true or in order to somehow prolong the big secret, that the test doesn't work.

Yes clinical validation is needed to establish exact performance but despite that, the process of bringing a product to market is very much in full swing. So one should ask oneself, why they are so confident.

@Kaysee I agree wholeheartedly on the complications, considerations and dangers of comparison and I would like to highlight that my "bar has been set to date" comments was in reference to the general principle of a rapid antigen test, being that Sona are effectively the only other company that is as advanced as AVCT, in this quest.

I personally see no threat to AVCT from Sona simply because the market is potentially too big for both of them put together and this is supported by the clearly co-operative approach Sona, Cytiva and AVCT have demonstrated in the Labroots webinar.

The analysis of Sona for me is because it is the best template we have for the path that AVCT will follow.

Where I do not agree is on the "news ASAP to settle our concerns." That for me is a sign of impatience. AVCT could not have done more to educate and keep their investors informed throughout this process and I see that policy continuing as things develop.

As the Sona process demonstrates, be it they made errors with their sample choices early on, these things take time, even when shaving off/running in parallel, a considerable number of the processes involved.

I am clear on what is key here.

1. The delivery of a test that is suitable for mass screening.
2. That when it hits each of its targeted markets, the demand will be there in sufficient quantities.

Right now No. 2 is very much there and for me will be for the foreseeable future. I am as certain as I can be that No. 1 will also be achieved.

All the time that this process is developing, along with the BAMS tests and for me the pending Covid therapeutics deal, time ticks by and we get closer and closer to AVCT going into the clinic with AVA6000.

According to the 2019 Annual Report ;

"Avacta has nearly completed IND-enabling studies and plans to file regulatory submission in the UK shortly (late Q2 or early Q3) to allow dosing of first patients with AVA6000 later in the year, or early 2021 depending on patient recruitment."

"Initial data are expected within a few months of starting the trial." (See page 23)

"If the pre-clinical performance of this drug is recapitulated in humans, then not only will AVA6000 have the potential to become a proprietary blockbuster in its own right, but the potential of the preCISION platform to improve the safety of a range of chemotherapies will have been demonstrated."

"The planned phase I study of AVA6000 prodoxorubicin in cancer patients is transformational for the Group."

Every day that ticks by, that trial gets closer.

The story around the AVCT Covid tests is highly likely not going to recede prior to the build up and deliver of that trial.

That trial is not alone, given AVCT now have £50m in the bank to exploit their platforms.

For me the longer this year runs, the more layers to the AVCT will be demonstrated. So I have no need for news flow to steady my nerves.

The MERC RNS stated "LGC, a global leader in the life sciences tools sector." Type that into google.

@RorkesDrift I believe it is LGC that have bought out The Native Antigen Company at what should turn out to be a very opportune time. That said, there is little information as to what exact deal NAC had with Sona for their biologics.

https://www.lgcgroup.com/

(2/2)
It seems like a low number for a validation but MRI Global are "CLIA certified, and FDA compliant," and that ultimately is what is required here.

In summary, the clinical validation exercise by MRI Global has been completed and the results are 96% sensitivity/specificity, such that the test can be sold for research only use, until such time the independent in field studies are completed and analysed.

Once completed and regulatory approval is gained, then the research only label can be removed.

All of which is why Sona at the end of their 2nd July update say "The Company cautions that its COVID-19 rapid antigen test is not yet approved by the FDA or other regulatory bodies."

What they don't say is that further clinical validation studies are required or still to be released because they have been indeed been already completed.

What they are waiting on now is that very limited in field sample study of 60 samples.

But for all intents and purposes, Sona have achieved a 96% sensitivity/specificity and that is where the bar has been set to date.

(1/2)
Morning all,

Something I wanted to try and clear up because I believe there has been a misinterpretation of the latest Sona lateral flow test validation results.

On 22nd May Sona contracted MRIGlobal "to provide analytical and clinical validation studies for Sona’s COVID-19 rapid detection, point-of-care, antigen test which will be used for submission to Health Canada for regulatory approval and the FDA for Emergency Use Authorization (EUA)."

MRI Global "has three ISO 9001, CLIA certified, and FDA compliant BSL-3 laboratories located throughout the United States and works with government and corporate clients from around the world."

"The project work will take place in MRIGlobal’s Kansas City laboratories and will assess Sona’s test using live SARS-CoV-2 virus following its past, successful internal evaluation using gamma irradiated virus."

Sona's Darren Rowles commented ;

“We are delighted to be moving into the final validation process and looking forward to the potential of a test that can tangibly advance the safety and quality of life for our communities."

Sona update 2nd July ;
"pleased to announce that its rapid detection, COVID-19 antigen test’s laboratory validation studies of performance levels have resulted in a test sensitivity of 96%, test specificity of 96% and a Limit of Detection (“LOD”) of 2.1 x 102 TCID50."

"Sales of the tests will now be permitted under a ‘research use only’ label until full regulatory authority is granted, in relevant territories, at which time the ‘research use only’ label requirement would be lifted."

A number of contributors believe this study was conducted with just 30 samples under a process where by "the remnants of each negative sample were spiked with gamma irradiated COVID-19 virus and the tests rerun to determine the positive results, generating the above result of 96%."

However, that reference is further test work carried out by Sona themselves only, which is tied into the "following its past, successful internal evaluation using gamma irradiated virus" statement above. It is not directly tied into the work by MRI Global.

The exact number of samples employed by MRI Global is not identified in the RNS. However, MRI Global were contracted to achieve the "final validation process," such that regulatory approval could be sort.

What has now been encouraged by MRI Global because (2nd July RNS) "regulators have placed greater emphasis on clinical, ‘in-field’ evaluations of rapid tests at the point of care to ensure they can be deployed with confidence."

is "independent clinical, in-field evaluation studies to generate the data to support its analytical and clinical data," which will involve "in-field collection of a minimum of 30 confirmed negative and 30 confirmed positive specimens and the associated data analysis."

@Canute40 Here is another quote from that Labroots Webinar, which adds to my previous statement about "external information."

Klaus Hochleitner ;
"We have to develop antigen tests that have a sensitivity that is much better than 95%, as it will not be useful for a screening test."

From the Cytiva website, Collaborations - "Avacta: Affimer-based point-of-care rapid screening test."

If its so damn hard to achieve, then why is Mr Hochleitner of all people, even contemplating the possibility of +95% sensitivity. Why not just say its not possible to achieve a test suitable for mass screening test.

In the latest RNS, he states "we are very encouraged by the initial data."

Again, if its not possible then is he selling himself out by placing such demands and criticisms in a webinar, only to then go on to back a test that is not suitable for mass screening, knowing fine well his partner is selling it as such. Remember this is a joint development between AVCT and Cytiva, not a manufacturing contract.

Am i to equally believe that Klaus has also fallen in love with his subject, after the doom and gloom performance he brought to the Labroots webinar table? Possible but those precentages reduce further when external sources begin to be included.

Again, its opinion based on logic and my own conclusions only and anything is possible.

However, what I am truly trying to do here is reduce the percentage chances that AVCT aren't successful at all because what that does is give me a back marker, to allow me to back the bigger and better outcomes, without risking too much.

All of this evidence says, at the very least, the test comes to market and does well, be it yes that a lower performance level could still be possible, which when added to the other platforms, still points towards a profitable outcome in the end. The bonus is that the above data when added to further external information/facts, gives me a very healthy shot at a much bigger outcome, for less overall risk than is actually generally being perceived.

Sorry one additional point.

My argument is not simply centred on "they've told us this so it must be true." it is also very much tied into who is telling us, how they are telling us and the timing of when they are telling us. All of which is tied into a wider external set of information.

we are not talking off the cuff remarks here

@Chengdo04 I hear you loud and clear and the message does needs to be repeated that nothing is ever a given in investing. All we can do is research and make percentage based conclusions on what we find out, be it invest or walk away.

The sorts of things you say are of course absolutely possible but the percentage chances are very low. We are now talking off the cuff remarks here. We are talking a consistent message that has continued past working test stage and into the optimisation phase.

Furthermore it is the very fact that it is perceived that such a high performing LFT isn't possible, that compounds the very argument that AVCT are capable of achieving because despite all that, they continue to push the same message with very little lip service being applied to the usual caveats applied to public company declarations. Yes that could well be over confidence or falling in love with the idea but it would also be highly irresponsible, which I don't believe this management to be.

I may of course end up being wrong. In investing there is always that chance and the least likely things often end up taking the biggest bites, excuse the pun. However, even if that end sup being the case I would still be happy with my process because the evidence strongly indicates that they believe they will meet their goal. That said, a lesser result is still an excellent fall back in terms of success, which when added to the BAMS test and the other platforms, offsets the longer term risk considerably.

Last point. Sometimes knowledge can be the biggest hindrance of all and prevents us from seeing what is directly in front of our noses.

PS I would welcome any counter arguments from anyone that may test my logic because i may well have missed something along the way.

(2/2)
I could also add that at no point in that IG video does he bring into question the success of the test. So its not just about what is said but what isn't also.

Like I say, I am no scientist or LFT expert. I base my decisions on logic.

Unless Dr Smith and his experienced diagnostic team, are deluded, somehow in denial or simply underhand in their dealings with shareholders, all of which are highly unlikely, be it always possible, then their actions are very much pointing towards a belief that their own minimum standards will be met, at the very least.

We must always be conscious of what has been achieved before and what most likely can be achieved now but if AVCT truly had doubts, then those 2 videos, surely should not have taken place and it is they that chose to stage them, nobody else.

I 100% support the need for individuals to be cautious and actual results will define this in the end but logic says to me, that they truly believe they will hit those mass screening parameters and for my sins, I believe them too because their actions point to such an outcome.

(1/2)
@Amphiprion1 Good morning. I have just had a chance to read your post from yesterday. I appreciate your stance and support the need to not get too carried away about the LFT needing to reach the top levels of performance, or indeed match Sona, in order to be successful.

I'm going to give you my opinion now but please do take it in the context of it being an opinion, that is my opinion only.

I hear loud and clear the argument that high performing saliva based antigen tests are not the norm, if indeed achieved to date.

I tend to take a logic based approach to investing based on information that is available from the company, tested by what I find out from other sources. An approach I dedicate a lot of time to. I am not a scientist, nor have I worked in the field and I do try to recognise that as I go along.

My opinion.

Despite reservations about the way the last placing was handled, I feel my trust in what Dr Smith says, is well placed.

With David Wilson as head of the diagnostics division at AVCT, there is ample well respected experience within AVCT, such that statements made on their aims for both the LFT and the BAMS test, should not be taken too lightly.

Furthermore, it is for me not just the release of the diagnostic performance video that is key but the timing of it as well because it came out 1 day before the working LFT test was announced.

So when Dr Smith states that in AVCT view "the minimum hurdles for a rapid antigen test for use in the general population is a sensitivity of 90% or better and a specificity of 95% or better" and that statement is made 1 day prior to the working test parameters being known, it is for me a strong indicator that the test is capable (at least at this stage), of meeting that criteria.

This is further compounded by the fact that Dr Smith goes on to state that "we are aiming for a high performance test with both the LFT. . . and the laboratory based test with Adeptrix."

In the table given earlier in the piece, an example of a high performing test is given as 95% sensitivity and 98% specificity, which again must be taken in the context of this video conveniently being released, just 1 day prior to the working test announcement.

Anything is possible but it is highly unlikely that AVCT published this video 1 day prior to these results, purely by chance. It is also highly unlikely that AVCT are blissfully unaware that it may just be construed, that their test can meet their own minimum requirements or better, because of the content they themselves decided to publish, on that particular day.

All of which is further compounded by the fact that Dr Smith appears on a IG interview 9 days later and openly discusses the need for 100s million of tests and the logistics of putting enough manufacturing in place for it. That being smack bang in the middle of the optimisation process, which defines the final product.