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"This pandemic is stretching the capacity of traditional testing methods. The scale of this pandemic, and the need for rapid, reliable testing means that new testing methods - such as saliva based LFTs - is being developed, as the need now exists (and the funding is there for the development)."

well i hope this potential contract isn't a sign that the UK is open to buying one, when they've already paid for a blood based one.

Is there a known lft antibody test that uses saliva ?

Why are people getting excited ? WE KNOW THE TEST IS TO BE USED IN HOMES. This is exactly what the MHRA approval is being sought for. The fact that BBI job offer states it, infers zero, I repeat ZERO, in regard to the status of the MHRA approval process. ODX has told us recently that a usability study is underway. Once completed the results will be given to MHRA, and then a decision will come from them.

Well, you have to assume that the RTC has to be extremely strongly inline for this contract. Several things spring to mind.
1) the existing "framework" is for 10M with "scope to extend to 15M". One assumes that if DHSC wants up to another 14M tests, then they would take them from the existing framework.
2) This bidstat is listed as a potential contract. There is no end date for tender, but delivery commences in Feb 2021.
3) the inclusion of swabs is quite confusing, both manual and automated, I haven't seen reference to antibody tests that use anything other than blood, but then I only know about such tests from following this share and associated news. The headline of the contract is "lateral flow tests", so what does swabs have to do with that, or is it an indication that whoever issued this doesn't have much idea what they are contracting for ?
3) "dynamic purchasing system", is this a fancy name for a call-off contract ?
4) For me, it would be a catastrophically bad signal, if this is for lateral flow antibody tests, and it is NOT given to the RTC.

I also notice this tender
https://bidstats.uk/tenders/2020/W49/740163812
135M to abbot laboratories, for goods related to testing for people who have had covid19. That's lab based antibody testing. This is a firm contract award. Only published a couple of days ago, but its a historic contract. for delivery up until Nov.
The detailed PDF says that this was just for goods, not a payment for the actual tests. Is £135M for the bits, one wonders how much the gov forked out in total to Abbot for the antibody testing. lab testing gives more accuracies and over the duration of We still only have 250K confirmed orders.

£104M for delivery over a 6 week period, thats what i call an LFT order.

BBC news article, saying manchester has paused the use of LFT for care home visitors due to the number of +ve missed compared to lab tests. I assume its the innova test as thats the only one circulating.
https://www.bbc.co.uk/news/health-55188183

our friend Mr deeks is quoted. To be fair on this occasion his quote is accurate.

"There is a difference [between] mass testing to 'break chains of transmission', where any true positive result is a gain - in that case it doesn't matter too much that you miss some people - and testing to 'be safe', where the focus is on whether the negative result is trustworthy," he explained.

There are a few things that could be influencing poor results
1) The test may be inherently poor
2) The user instructions could be poor
3) The instructions could be good, but given that the preferred outcome for the user is a -ve test, there may be some unintentional bias on behalf of the user not to be thorough in taking the sample, if it is self tested.

I'm guessing no matter how good the test is, if an untrained user is involved, who wants to be negative, and the process is quite detailed, then the users impact is likely to have a greater input into the accuracy of the result, that the underlying accuracy of the test. So a test that is inherently more accurate, will have a bigger impact when user by a trained 3rd party person, that if used by the enduser.

two points
1) Do we have any data comparing Mologic to Innova.
2) If there is a substantial market for LFT antibody testing, the ability for the end-user to affect the outcome is likely reduced compared to an antigen test, as there are probably less user input variables in a blood prick test than in one that involves swabbing areas of the noise and mouth and then mixing with an agent.

It was sales PR, which wasn't backed up by any source for the "its is expected...well it excess....3B+" statement. It was leapt on here by those that saw it as confirmation. To be fair, it was produced by a member of the consortium, and so it carried weight. I'm guessing the UK listed ODX didn't like that a 3rd party was inferring 750M unit sales for them. (25% of 3B). A bit embarrassing that you have a partner implying 750M sales, when you have actually announced orders of 250K. I suggest that's why it was removed.

There is a belief on here that it's purely the MHRA is holding back the RTC from getting orders for antibody test from uk government, making a rather big leap that LFT antibody tests have no volume application outside home/self test. Is there not a need for volume LFT antibody testing at POC. If so, leaving the UK aside, can anyone on here point me to any country that is mass producing. or has mass advanced orders for antibody tests . Remember vaccines are not for home use, and there is apparently well in excess of 10B advanced orders. So even if there is only a 1% requirement for antibody tests at poc, thats 100M tests that should be on order for use in non-home environment, if there is an explicit link between vaccination and antibody testing.

It was me that submitted the question to the previous CK presentation, asking whether it was expected that a vaccination program would result in a mass antibody testing requirement, and CK said in reply that he did expect it, and the consortium and CK has repeated this expectation subsequently.

I've yet to see mass orders anywhere in the world that backs this expectation. I've yet to see any government lay out a program that antibody testing is aligned with vaccination, and certainly no government has shown the same urgency in getting supplies of antibody tests as vaccines, for something that is supposed to go hand-in-hand. I am reminded that the uk gov ordered a rather small 1M RTC, in the very last days before they had to make an order before the agreement expired.

Substantial orders by any government anywhere in the world for any antibody test, would be very reassuring.

"What exactly news wise are we waiting for, before this takes off?"
orders

you do realise that webpage was last updated over 2 months ago ?

Remembering that CK in the presentation yesterday said that production increase would be driven initially by antigen test sales, then clearly we need an antigen test.

For ODX to get signficant antigen tests sold to uk gov it requires:-
1) TT to be completed. Was postulated as a chrsitmas present, but now is into Jan. It was my understanding that TT would not practically start until Mologic got CE approval for their test. ODX have said they've formed a team and begun the process.
2) ODX Need to get CE approval for their own test.
3) Need to be selected by UK government for validation and get to the same stage as Innova (phase 4). It is possible that the Mologic test is at phase 3, but it is also possible it is not one of the 5 at phase 3. I am working on the assumption that the mologic test IS at phase 3. Uk Gov document on the validation process has not been updated since 23rd of oct, and only lays out 3 phases.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests

But this press release dated 11 Nov, indicated the Innova was in phase 4.
https://www.gov.uk/government/news/oxford-university-and-phe-confirm-high-sensitivity-of-lateral-flow-tests

Its possible that the Mologic test is in a formal phase 4 trial somehere (we know its being trialed in different environments)

But as it stands, no other phase 4 antigen test has been announced by uk gov.

4) It is unclear whether the ODX test will be seen as a complete generic variant of the Mologic test and will automatic inherent the validation that the mologic one has (assuming the above). Or will it require an independant validation process.

So looking at the above, although it is clear that ODX remain confident that they will have significant antigen test sales to uk gov, one can see that there are still several stages to get to a position where they are in a position to do so. All of which takes some time and requires success. I can see why Finncap does not have full visibility on the covid opportunity at the moment.

For me ODX is a pure covid play, as is the case for the vast majority of PIs who like me probably never heard of ODX before Covid. I don't expect to be in ODX in 2023 when they are forcasting 1M food intolerance tests in China, for example. I've been told there will be 100s Millions LFT covid tests from ODX by then. When that becomes visible, the SP will respond. That's why i'm here. If the projected covid capacity can then be replaced with other tests of equal capacity, then there may be a case for extended investment. But my timeframe here currently isn't 2 years.

There is no panic from me, just keeping the story based on the facts, and not on factless suposition.
They have two antibody LFT tests they can make. For one, they have an order for 250K. They have not announced any orders for the other. It's reason to assume that an order of 250K or more would be announced. They do not have an LFT antigen test to make. That is the total covid LFT tests ODX has developed/indevelopment. They have said nothing to indicate a signficant stock build up. They have indicated that production will increase in the short term based on antigen tests (which they don't have). If they were building stock it would deplete cash, putting the finance for the capacity ramp up at risk, and they've said that is not at risk.

Its very simple maths, they are not producing at capacity, Finncap doesn't think they will produce at anywhere near the projected capacity right thru to the end of H2, giving the current visibility.

As soon as orders come in, that will change.

I'm not sure where or why some are picking an argument with the above, or are panicing when exposed to the facts above. Its very plain, and does not change the potential opportunity. potential changes into actual on signficant orders

I haven't been at all hard on CK. The only reference I made to CK is to facts he stated.

The primary point is that the narrative portrayed on here by many (not by ODX), to try to over egg ODX, is that they were producing at maximum capacity, implying either stock build up of RTC tests, or major sales of the Visitect test. The presentation to me confirms my belief that they are not producing at maximum capacity. The fact that finncap also states they don't have visibility, such that they only predict income of £2M in total for all covid tests for H2, says they also do not see production matching capacity. If orders are announced, they clearly my opinion about covid-19 lft output changes.

ODX is potentially a very good covid play. But Its not helpful to overstate important things like production.

figtreeharry, the CE approval relates to Mologics antigen test, which they projected they would have by Oct. I have no idea why people are quoting links to CE approval for the Mologic antibody test

Astrazenca has pre-orders for 3B vaccines.

figtreeharry,

And no matter how many times that link is posted, it doesn't change the fact that the link refers to the mologic antibody test, which odx has TT many months ago (now known as the visitect antibody test).

bomber64, comments, by definition are subjective just as your comments are. However leaving comments out of it, and just sticking to the facts

1) MHRA is now at "usability study" level. Which is an advancement of the known position as per the Abingdon prospectus a few weeks ago. Other than being described as short, we have no indication of the length. We have no indication how long MHRA will take to review the study. MHRA has already taken a lot longer than envisaged, according to CK.
2) CK said the bulk of new capacity will be taken up with antigen ( the implication being at the initial stages). We dont have an antigen test. This means the bulk of the capacity will NOT be antibody tests at the outset, in CKs opinion.
3) Ck made no mention of antigen test TT completion by Christmas, a departure from his previous statement, where he referred to a christmas present. He indicate early Jan. We are now start of Dec, and Mologic has not announced CE approval for the test. They indicated in a presentation in OCT that end of that month was what they were aiming for.
4) We still don't have any announced orders from Government for the RTC test beyond the 1M. ODX has previously said that confirmed orders beyond the 1M will be RNSed. Ck indicated we will get 250K, up from 175K, from that initial 1M order.
5) There was no statement during the presentation that implied any Covid-19 LFT stock build up is happening. The interim results were for up to 30th sept, and thus not relevant for the purposes of determining the amount of Covid-19 LFT stock on hand.
6) There was no mention in the presentation of any numbers in relation to orders for the visitect antibody test, agreements were cited.
7) Finncap, estimates £2M incomes from covid19 LFT for H2. Finncap said they don't have sufficient visibility on the covid opportunity for ODX, to go any further
8) It was re-iterated that the expansion up to 2M is fully funded, without needing additional financing.

There was of course a lot of data and comment related to CD4 and food intolerance, but ODX is a covid play short/medium term, which is my interest.

Whether I hold or not, and i stated my position only a couple of days ago, has no bearing on those facts.

Comparing the abingdon prospectus with the presentation yesterday, there has been an update. Abingdon said that they were waiting for MHRA to come back and approve the process, at which time a short usability study would occur. It appears that the first part of that has now happened.

So who is doing the usability study , and how long might it take ? Lets hope its a prioritiy, and then MHRA dont take their time in reviewing the study.

On the antigen testing, it was very clear to me that there isn't going to be TT-ed by christmas, as it was not suggested even as an option.

The results were until Sept 30, so unfortunately the finances dont give visibility regarding how much stock has been built up in the last couple of months. Against the overwhelming opinion here, I have mentioned several times that I do not think that ODX is producing LFT at capacity. It is interesting therefore that Finncap appears to agree with me. They forcecast £2M revenue from Covid LFT in H2. Its open to discussinon how much 1 LFT equals, but we can all agree that £2M does not come anywhere near the accumulated capacity for H2. They may be being conservative, but they say in the note that they do not have clear visibility of the covid opportunity. It was also worth noting that CK did not repeat the statement from the OCT presentation, were he said at the time (and I'm paraphrasing) that the capacity up to 500K a week was more or less reserved. It is also important to highlight that he emphasis that antigen test would make up the bulk of capacity. Remember that ODX does not have an antigen LFT at this time.

Taken all together, I think its clear both from expressions in the presentation, and finncap, that capacity is not being maxed out at this time. There is also not going to be a short term ramp up in antibody LFT sales.

I was calmed that the message regarding funding for the expansion remains unchanged, that they have the money to do it and do not require other funding. Given delays of ramp up for antibody LFT orders, I was concerned that income might be lower that anticipated

THere is no CE yet for the mologic test, or at least we haven't been told of one.

When Mologic get their test, and ODX do the TT-ed and have their visitect branded version say 4-5 weeks later, and get it CE approved, are mologic and ODX now competitors for the orders from UK or elsewhere ? Or has some agreement been made ?

If mologic are a certain stage down the road of getting qualified by the UK gov, and we have no idea if there are one of the 5 or not, do ODX have to start at the beginning and ask the UK gov to start at phase 1 with their test, or will the UK gov just take it that ODX visitect test is simply a rebranded version of the mologic test ?

was discussed yesterday

I was correcting errhums numbers, he was suggesting ODX have a 1M order. it’s the consortium that has the order, and the ODX rns said they will make 175k tests out of that 1M.