Member Info for Okehurst1

Zedmed are selling direct to individuals/ citizens in the U.K.this is illegal as the product has no MHRA clearance and requires a medically trained person to administer.

Just on the CE stamp, this is basically a self regulated certificate that any director can apply for, it carries no real gravitas, as an example look at Mologic,their clinical test was on just 28 people, the CE stamp gives almost no real confidence that the test works and is about as useful as a chocolate teapot.
We can expect Avacta to announce their CE certification quite soon but it’s the MHRA one we want to see.

Back to Zedmed.

You can only guess where this outfit is really based?
The buffer / reagent will be from where anyone can buy it being , via Alibaba, it will be a similar solution that Innova are using and the rest of start ups who says they have an accurate Covid 19 test

Individuals in the U.K. with symptoms of Covid 19 will be buying this test on line, a good chance it will only pick up a small percentage of positive predictions if any and the individual thinks they can get on with their life and not self isolate and off they go to the supermarket / mix with work colleagues be that in care homes wherever, pop to see Grannie.

No wonder we are on our 3rd national lockdown and London Hospitals for example are at breaking point.

Copied / pasted from Zedmed web site - maybe the spelling mistake is a giveaway?

‘ZED MED Medical Equipment suppliers We are happy to accpet orders from individuals ..... ‘

Thanks for sharing Lee

It’s close Arnold

I don’t think it’s about the S&S anymore, all the outfits out there promoting their test using a generic buffer quoting 98% or whatever, personally I think it hinges on the positive prediction percentage to the decision makers/ governments.

Avacta’s LFT needs an average 85% plus positive prediction ,if its 50% to 60% we are just like everyone else, we need that high average to stand out and give comfort our test is highly accurate and not a toss of the coin.

We also need to see an average double digit pg/ml , full range of Ct values from 15 to 30 ideally, if Avacta announce the above and a high positive predication rate then Avacta have their so called gold standard

Hopefully we know next week, one way or the other.

According to the Government

‘Global manufacturing capability is limited to circa 120m units per day ‘

If this capacity is switched solely for Covid testing and you had a business that had a business model were it’s not interested in engineering but just licensing it’s biotech and receiving royalties and you happened to have the best performing antigen buffer/ reagent in the world?

Based on current known production capacity it’s a 44B a year of LFT’s that can be switched to Covid 19 testing

Avacta’s BoD have proved they can hunt down licensing deals around the world ,it appears they have that skill set.

If Avacta announce stunning numbers from the clinical trial, the mind boggles at how much of that 44B p/a of LFT tests they can tie up licensing deals with ?

http://bidstats.uk/tenders/2021/W01/742457586

Worth a bump this paragraph

‘In the area of neurodegenerative disorders, including Alzheimer’s disease, BAMS MALDI-MS was able to monitor various levels of heterogeneity of key biomarkers such as beta-amyloid and tau protein in cerebrospinal fluid fractions (CSF) and brain tissue, to distinguish between normal and disease states. This demonstrates the potential of BAMS technology for biomarker validation studies as thousands of samples can be quickly analyzed both at the protein or the peptide level, and converted into a rapid test.”

Bit more on Zandcell

The Administrative Court of Uppsala went on to find that the prohibition of the sale of the product was lawful because, even though the tests at issue do not need to have preliminary approval before sale, they but must be CE-labeled and hold a certificate from a “designated agency” that the product meets the requirements for being sold on the Swedish market. (8 § 1 p LVFS 2001:7.) The court found that Zandcell AB had been unable to prove that the COVID-19 test kits met these requirements. (Decision at 12.) Thus, the sale of the COVID-19 test kits continues to be prohibited. (Decision at 13.)

Interestingly Zandcell have been banned from selling their test in their home country, going to struggle to sell overseas?

https://www.loc.gov/law/foreign-news/article/sweden-administrative-court-upholds-prohibition-on-sale-of-covid-19-test-kits/

Supernova
Bit of help with your research,
Innova test is 3% effective

Not sure on Avacta as yet but if Innova is top of the pile with 3% accuracy the bar is not set too high,thanks for the post didnt realise Innova was the best test out there.

https://www.dailymail.co.uk/news/article-9078417/Rapid-Covid-tests-used-Operation-Moonshot-CAUSE-outbreaks-schools.html

Just on the question is PCR better than BAM’s?
Below is a telling paragraph from a PHE document re PCR.

Understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR
A guide for health protection teams

‘Understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR
Figure 2.
RT-PCR detects presence of viral genetic material in a sample but is not able to distinguish whether infectious virus is present. The quantity of intact virus in upper respiratory swabs will be affected by factors that are endogenous and exogenous to laboratory methods’

We have limited data on BAM’s at the moment but PCR according to PHE is not able to distinguish if a person is infectious, if BAM’s could identify infectious people it would surely replace PCR

Agree, thanks for sharing Monk.

As always MB a good debate, we both have a passion for Omega as a well run quality British Diagnostic’s Engineer, it’s an excellent business.

MB, it was on the positive prediction ratio, it averaged 62% , it was Mologic’s own clinical trial not LSTM ( 28no)I’ve seen it somewhere , it was on 100no participants Mologic did disclose this ,will try dig it up later.

Switch off about the 92% sensitivity it’s pretty much useless in terms of identifying will the test be accurate in the field on Live samples, it’s the positive prediction % thats the key stat.

200pg/ml average is not going to be good enough for an accurate self administered home test and a basic buffer/ reagent won’t capture viral loads over a range of 1.00+E to 7.00+E and Ct 15 to 30, it just wont.

I do agree Mologic are a good business, like their ethics as well but in this particular case they have as yet not produced a test to pass MHRA based on disclosed data. Avacta haven’t either, we just need one of them to deliver for ODX, it’s irrelevant which one, we will make our profit off either.

The Aptamer group being awarded what was a £250,000 grant last week from the Government to develop their Aptamer test was to me a signal that the Mologic antigen test was not going to secure MHRA clearance and the Aptamer Tech hadn’t yet been proven successful.

This was coupled with the limited data that Mologic released indicated their test at an average 200pg/ml wouldn’t be accurate enough to identify a high percentage of positive predictions as a self administered home test, plus it wouldn’t pick up the Ct ranges required, predominantly Ct15 to Ct30 to capture low viral loads.

Mologic themselves say their test is only 62% accurate on average identifying positive predications, its a wee bit better than a toss of the coin.

There is no guarantee that Avacta have covered the ranges above within their LFT but the fact their Elisa Machine Antigen test identifies at 40pg/ml gives some confidence that the Affirmer being smaller than an Aptamer may well be able to identify the spike protein of Covid 19 in conditions akin to looking for a needle in a haystack.

The Tweet last night indicates that Mologic have seen the pre clinical Avacta data and will be manufacturing their test using the Affirmers/ reagent /buffer.

ODX cant lose, if this is the case they will manufacture the antigen test for Avacta, it’s almost irrelevant to ODX which test they make, they will make a good profit off either.

We won’t know for certainty for a week or so until Avacta disclose the results of the full clinical trial, they may themselves may not outperform the Mologic 62% data however after last nights tweet it’s odds on it does and by a difference that is material.

Lee, I’ve not been following Sona since the announcement below, have they since released an antigen test that works?
If they have interesting to see their data.

https://sonanano.com/sona-nanotech-withdraws-rapid-covid-19-antigen-test-application-based-on-feedback-from-health-canada/

Energyshares, thanks for sharing the info, agree with the sentiment of your post below as well.

Sleepydave,

I’ve not been convinced for a while now that Mologic can produce a quality antigen test that will pass MHRA without something added to the reagent / buffer, however when they announced a partnership of sorts with Aptamer Group then like many on this BB we were anticipating that they may have a chance to succeed, however this weeks disclosure that the Aptamer Group were awarded what is a £250,000 investigative grant indicated both them and Mologic are out of the race for the self administered home test market - reagent / buffer on its own just won’t make the grade

However this doesn’t stop Mologic taking the Avacta Affirmers if Avacta pass clinical trials, Innova , Abbott they all could in theory, Alister has already indicated Avacta would be seeking licensing deals.

It actually makes sense as Innova’ s kit as an example has already passed Porton, they are halfway there and they have the manufacturing capacity.

My opinion if we pass Porton Down Phase 3, we will take all of the U.K. a manufacturing capacity then license the Affirmer solution worldwide, max the opportunity.

Of course first off we just need to see a very high positive predication, 50% to 60% only puts us at the same level as Mologic / Innova /Abbott

Any doubts to the size of this market worldwide

An annex to the contract stated: “The supply of these new test kits is currently limited in the face of very high global demand and consequently it was necessary to contract for supply […] for product manufactured in China in order to secure the required quantity of product and prevent gazumping.”

https://www.theguardian.com/world/2021/jan/01/ba-among-airline-firms-paid-millions-to-ferry-in-covid-testing-kits

Retireby,
Suggest TT has happened, as has desk top/ Pre clinical,
don’t think thats the issue for Avacta and their LFT, it’s all about the clinical trial now and the LFT data/ performance.

Speculating but it does feel like we are in Porton right now or close to next week, it’s coming.

Hi MB
Good debate as always

Look I may be wrong but I don’t think Mologic can get the range just based on the buffer/ reagent
I thought they would be using the Aptamer but that looks unlikely now after the Apatamer group won the £250k exploratory contract.

The only other man made molecule small enough to identify the protein spike is potentially the Affirmer - we know this works inside a machine to 40pg/ml but we don’t know on an LFT

Either way ODX can’t lose, we may be able to squeeze more margin if we have two biotech companies looking for manufacturing partners ?

Scarley, good point
I thought 2.6.2 was aimed at teachers - May be wrong
that looks like a no goer ?
Innova was down to 50% positive predication when administered at home - ok Deeks had it down to 3% but discount that

My personal view I don’t think Mologic will be make it into the hat for this tender, we will soon find out of course