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Sensyne app.... but note govt target 100m tests/wk
“Sensyne Health's app approval 'unequivocally positive', says broker
“We estimate that there will be as many as 100mln per week of these distributed in the UK"
“Sensyne Health PLC’s (LON:SENS) announcement that its MagnifEye app to improve the accuracy of instant Covid-19 tests has received UK regulatory approval is ‘unequivocally positive’, according to broker Liberum.
The MHRA has granted authorisation of special use alongside the Innova lateral flow test.
Innova was the brand originally used to test the MagnifEye technology as part of an NHS Digital pilot study, notes Liberum.
“We believe that all current NHS provided lateral flow tests are the Innova brand,” added the broker.
“We estimate that there will be as many as 100mln per week of these distributed in the UK if the government hits its desired aim of every adult testing themselves twice weekly.”
Sensyne Health receives UK regulatory sign-off for AI technology that automates analysis of COVID lateral flow tests
The broker added there remain many unknowns, such as how or even if MagnifEye will be integrated with these tests, but it opens a route to significant revenues for Sensyne if it can find a way to use today’s approval to strike a commercial agreement with the NHS.
“In terms of the theoretical financial opportunity, even at half the royalty it gets from its current testing partner, Excalibur, the maximum revenue potential would be £4mln per week.
“For context, we forecast total revenues for Sensyne of £27mln for fiscal 2022.”
Shares rose by 2.5% to 167.5p.”
https://www.proactiveinvestors.co.uk/companies/news/948834/sensyne-health-s-app-approval--unequivocally-positive--says-broker-948834.html
Ps I can’t sleep tonight! Lol!
Trek
Just trying to explore the realms for interesting words that can be used on this forum to prevent the insertion of too many of these things *****
How about 'gash'?
It could also be that we have targeted the S protein over the N due to there being more S in the AN and more N in the NP areas of the nose. Al targeted the s due to ease of use imo and it turned out spot on. I could be wrong but I reckon not.
I have been wondering why Avacta haven’t released an N protein Affimer as well - it only seems to be the most in demand product in the world of diagnostics right now. Perhaps the quality of their spike-binding Affimer is better than the corresponding N binders they found? Or perhaps for similar reasons as why they are not doing an antibody test - everyone else is doing it? But if they can do it better, why not? I would like to see if they can come up with all the reagents for the combined S/N test with Mologic.
The interesting thing is, if N-protein LFTs establish enough of a presence that they are making a dent on the virus, it will be a selective evolutionary pressure that drives mutation in the N protein, in which case having a spike test is beneficial. Natural immune responses to the virus seem to attack the S, N and M (membrane) proteins in similar proportions (e.g. https://www.medrxiv.org/content/10.1101/2020.05.13.20100636v1.full.pdf). However, I think the observed mutations in VoCs have mostly been on the spike protein (need reference to support this view but no time now), largely as it affects (and can boost) the cell entry function.
Yep spot on PAH and AS covered this briefly in the Q&A when asked about the process off adding new affimers to the test should they not pick up a mutation.
I think some thought each mutation would need a new Affimer but he explained the process would be relatively quick to do given affimers can be produced in a few weeks, however, it should be something that occurs very irregularly - for the exact reason you put very well below.
Avct have plenty of bases covered.
Again, although it’s taken longer, for me, it’s quite clear doing this right first time will have much larger long term benefits than the “opportunity cost” of not having a test out for a few months.
One major advantage Avacta have, is that if there is a variant that escapes an 'N' test, then the developer will have a much longer lead time to come up with a new test / new antibody (3-6 months). Despite there being less of a possibility of a mutations in the 'N' protein, it is still a possibility, so would the govt want to commit to an 'N' sovereign test, knowing that it could be redundant for 3 to 6 months should such a mutation occur? Wouldn't they rather have a highly accurate 'S' test, which targets the parts of the 'S' protein less susceptible to mutations, knowing that Avacta can knock up another affimer in about one month, in a worse case scenario. Common sense dictates the Avacta route.
Of course, there is also an argument to be made for two sovereign tests...best 'S' test and best 'N' test, to cover all bases, until such time as Avacta/Mologic come up with the silver bullet S/N test.
That 3.7 paragraph to me says that Mologic/GAD are ensuring the initial production sample tests have passed the PD-equivalent process.
“ensure that agreed quantities of pre-Production samples and testing samples of the Goods ... have been tested in accordance with testing procedures and test success criteria agreed with the Authority ... and have been confirmed as meeting the same standards and equivalence as the tests which had previously been performed on the Goods by Public Health England at Porton Down.”
No question on my mind it is us. The only risks left on securing the government orders and manufacturing capacity are around passing the MHRA approvals, and unforeseen political shenanigans. We just need CE mark and to pass the MHRA approvals before we can sell to the government. I was worried that PD might provide further hold up after CE marking, but if Mologic are doing that part perhaps it won’t be as much of a wait.
@Radiagreen: I'm not sure it's decided yet, though I think there is every possibility that Avacta are in Phase 1 of the GAD contract (even though the contract states that Phase 1 should have completed by now, these timelines are not necessarily set in stone). For all we know Avacta are being fast-tracked through PD as we speak (with amended protocol re: frozen samples), or the govt just accept the 'alternative validation route' as described in the original £912m tender. Be nice to get some closure on this, it's been like participating in a year long game of Cluedo.
We’re nothing like SONA, and the n/s debate has happened forever. We’re S, the other are N. Non of the others have been chosen to date. Simple as that.
We’re the best performing test.
Decided through conversations with the government.
Scardey,
We can debate the text you raised but regardless, I think we agree that the role that GAD and Mologic are performing on behalf of AVCT (which they are not doing for any other partner) that sits so perfectly with the vast majority of the GAD/GOV contract SOW cannot just be a coincidence.
Question though... At what point did the Gov decide that avct was preferred test? Did they decide via tender process, evaluating cost and performance or some alternative route?
Yes, agree they are being more flexible and realistic. Hence the equivalence test requirement.
@beinthelead, just pointing out inconsistencies in the contract, in so far as, in one part of the contract it intimates that the test would not have passed PD at the time the contract was signed (as Muck pointed out) and yet para 3.7 completely contradicts this. As I said, it's difficult to draw any concrete conclusions from the GAD contract.
However, I agree with PAH that logic dictates it has to be Avacta. The CV results are just too impressive for it to be anybody else. Just need to get over this 'passing Porton Down' conundrum, but I'm sure if the govt want the test, they'll find a way to skirt around that.
i note good old Zak Mir is going for 350 in the short term, based on the charts alone
talking about Scotland , despite their current troubles, Celtic is the top team
How scardey?
Exactly Radia. Most telling piece in the contract for me, word for word.
Except for this bit Radiagreen:
"and have been confirmed as meeting the same standards and equivalence as the tests which had previously been performed on the Goods by Public Health England at Porton Down"
Isn't it odd that GAD are doing exactly as laid out below on behalf of AVCT?
"3.7 The Supplier shall by the Long Stop Date and subject to the Supplier and Mologic having entered into the contracts referred to in clauses 2.3, 3.1.9, 3.1.10, and 3.1.11 where required by the Authority, ensure that agreed quantities of pre-Production samples and testing samples of the Goods (“Pre-Production Samples”) have been tested in accordance with testing procedures and test success criteria agreed with the Authority (which as a minimum shall be in accordance with the requirements of the MHRA for Product Authorisation and CE marking) and have been confirmed as meeting the same standards and equivalence as the tests which had previously been performed on the Goods by Public Health England at Porton Down, such samples to be manufactured in conformance with the Specification."
Also, Muck, para 3.7 seems to indicate that 'the Goods' will have already been tested at Porton Down. This contradicts the other references to Porton Down status that you mentioned. In my experience of govt contracts, they are never word perfect and are subject to the same slip-ups and inaccuracies as any other legal contract, so we just can't make too many solid conclusions from these contracts.
"3.7 The Supplier shall by the Long Stop Date and subject to the Supplier and Mologic having entered into the contracts referred to in clauses 2.3, 3.1.9, 3.1.10, and 3.1.11 where required by the Authority, ensure that agreed quantities of pre-Production samples and testing samples of the Goods (“Pre-Production Samples”) have been tested in accordance with testing procedures and test success criteria agreed with the Authority (which as a minimum shall be in accordance with the requirements of the MHRA for Product Authorisation and CE marking) and have been confirmed as meeting the same standards and equivalence as the tests which had previously been performed on the Goods by Public Health England at Porton Down, such samples to be manufactured in conformance with the Specification."
I assume it is the Sovereign test that is being 'validated via the alternative route'
I noticed the PD references too Mick, but I just think that's in there as a coverall situation, so can't read too much into that.
I’ve been wondering about p83 too PL. Apart from what you’ve noted, it seems clear from the comments relating to supply chain dependencies/timescales that, whatever the selected test is, it had not passed PD assessment when the contract was signed.
Well has this can taken an almighty kick down the line? Or do we still get announced once we have CE ?
And what about the 8bn DPS, the up to 30m per month which may be completely unrelated or the OEMs
Dots all over the place