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Who knows re validation-the process should not be a secret as we are not getting any government handout. As this is the case I have tried to understand more about the science which is the root of all the games with evaluation of samples in the lab. Why has that not passed quickly when as an AVCT holder I firmly believe the efficacy of affimers. A quick validation and scale up would have seen antigen LFT replace antibody and pcr tests and the public on side due to the results. I am really looking forward to who will lose their head when answers are known as part of my consolation. The other part being a return on my investment that sees me in clover.
Perhaps they’d reached an impasse. PD have established methods for their lab evaluations and couldn’t/wouldn’t flex to be able to assess our test as we’re targeting the spike. The govt still recognise its potential and so have agreed that ultimately it’s the clinical validation that counts so told them to crack on and get in touch once it’s CE marked and the results are available for Deeks etc al to pour over. Might all be amicable. We crack on and get going whilst they continue to build up the manufacturing base - all using the same standard kit. Who knows....
I forgot to add, ultimately I expect an initial minimum of 3 Avacta manufacturers, GAD, who then passes on TT approval to BBI & Abingdon.
Any body want to hazard a guess at manufacturing output?
I’d just say Avacta can’t threaten the Govt. All it has do is deny them an export license or similar action.
If the test is any good it’s in bith the Govts and Avacta interests to come to a deal - there’s probably innin place slready as others have stated
“I was wondering if you or anyone else had any thoughts on this, which I was thinking about today:
Would Avacta have to use LFT's manufactured by Mologic for clinical validation, if Mologic are to CE mark the test?”
Just my opinion, but I think yes. In the early days when we were discussing TT of our saliva test, our two manufacturing partners were, (and I strongly believe still are), BBI & Abingdon, but BBI were the designated “lead” supplier and were responsible for taking Cytiva’s “design frozen” tech and establishing a production line format capable of TT. Once complete, pass samples to Porton Down, get approval, then that could be CE marked & production started with any other supplier in the program, (in our case, Abingdon). To this date, we haven’t received any confirmation of TT from BBI.
Since then, a pure saliva test has pivoted to AN, and we we’re now in re-development mode.
“I seem to remember Al saying that the CE mark had to be based on data from the final product, would that mean that the owner of the CE mark would need to have manufactured the test before transferring the protocol to others (BBI) as an equivalence? “
At some point we got into bed with Mologic, and we’ve obviously done lots of collaboration work together since then. Don’t forget, they were developing their own antigen test, (of which, any progress regarding approval etc. has been
non-existent to date. Incidentally, Omega are still waiting for any such approval in order to complete their own TT, to be sold under the Visitect brand).
Regarding manufacturing, Mologic, have GAD, (Global Access Diagnostics), their own manufacturing division. I believe GAD will/have manufactured Avacta LFT samples for maybe Porton Down & Spanish/UK hospital testing and CE marking to allow sales into Europe.
“If so, perhaps this statement that "Avacta will immediately be able access initial manufacturing capacity through Mologic, in addition to scale-up manufacturing capacity with BBI and Abingdon Health" infers that production lines are already set up at Mologic?”
A big yes from me. Another big incentive for Mologic/GAD is their commitment to their manufacturing/supplying low cost tests to 3w countries.
“In this context, Avacta and Mologic's collaboration dating back several months could be referring to the tech transfer? “
“If this were the case, I wonder if its possible that LFT's have been pre-manufactured ready for roll out post-CE marking? “
“It would make sense with Mologic CE marking to shave 4 weeks off time to market - and the anticipated reopening of schools...?”
Another yes, (sorry for being repetitive).
“Keen to hear anyone else's thoughts..!”.
.........plus, I’ve rambled on a bit, had a couple of lockdown ciders, apologies all!!
The ultimate FU to HMG, all the British manufacturers start manufacturing our test and ship them to the EU.
Also given the week that the govt have had with contract issue controversy Im not sure they are keen to dish out a massive contract for testing until the heat dies down. Timings all being controlled by govt in my view
I’m seeing CE as a bit of a smoke screen and possibly a veiled threat to the govt that if they don’t act fast we will have a CE mark and everything can go to europe.
Don’t we validate differently in the UK now and don’t need a CE mark
@theAlchemyst - thanks for your comments which are helpful.
I was wondering if you or anyone else had any thoughts on this, which I was thinking about today:
Would Avacta have to use LFT's manufactured by Mologic for clinical validation, if Mologic are to CE mark the test?
I seem to remember Al saying that the CE mark had to be based on data from the final product, would that mean that the owner of the CE mark would need to have manufactured the test before transferring the protocol to others (BBI) as an equivalence?
If so, perhaps this statement that "Avacta will immediately be able access initial manufacturing capacity through Mologic, in addition to scale-up manufacturing capacity with BBI and Abingdon Health" infers that production lines are already set up at Mologic?
In this context, Avacta and Mologic's collaboration dating back several months could be referring to the tech transfer?
If this were the case, I wonder if its possible that LFT's have been pre-manufactured ready for roll out post-CE marking?
It would make sense with Mologic CE marking to shave 4 weeks off time to market - and the anticipated reopening of schools...?
Keen to hear anyone else's thoughts..!
From last years presentations affirmers can be produced rapidly, "in a matter of weeks"
I recall 4 weeks was the timeframe for Cytiva.
Could the Spike protein and Neucloidcapsid (S and N protein) LFT be readied for end of March???
Or is this a consideration for a later date?
The drive is to get a Product to market.
Test, test, test
Avacta have played a blinder in their RNS, not sure how I missed it first time around, they are essentially stating without saying it directly that unless a Competitors LFT can match the sensitivity of the Avacta device it is not fit for purpose. Dont think any other manufacturer will be able to match PCR CT 25 and if they cant , and they' ll need to prove it through Clinical Validation, I think the whole lot is Avactas if the evaluation matches the preliminary result that is. Boom.
Yes it does look that way Alchemyst. If I were to guess, the Govt have been in direct communication with Avacta, Mologic and Surescreen continuously over the last few months. The govt have probably told them they will get a big order if the following can be met:
Pass Porton Down assessment
Charge £5-6 per test
Anterior nasal ideally
Begin selling by April 2021
The Mologic CE marking speeds up the processes, but also decreases risk, as if Avacta accreditation is delayed further (it's already been delayed at least once) they would look pretty silly.
Thanks TheA - makes sense re BBI and agree re the urgency!
The LFT to market must be very urgent. All of the technical documentation and product paperwork and packaging, cartons, instructions for use will need to show the Mologic name and address, then be changed to Avacta when they are ready. A lot to do for a couple of weeks.
The difference between Mologic and BbI is that Mologic acts as a legal manufacturer in their own right, BBI acts as a subcontractor and their scope of ISO certification/ISO audit would be focussed differently.
Mologic, as a legal manufacturer, would have good practices for development and manufacturing, but also distribution/traceability systems, regulatory systems, customer services and systems for post market surveillance (the additional obligations of a legal manufacturer which Avacta is also putting in place or subcontracting)
BBI, as a subcontract manufacturer, would be expected to show that they have good practices for development and manufacturing but usually no further responsibilities.
I am not sure about the terminology, but I believe BBi and. Abingdon Health are under manufacturing contracts/agreements. Mologic and Avacta have a commercialisation agreement.
There are a lot of smoke and mirrors, that's for sure. Why did Mologic get initial data and CE mark last year and are still being evaluated by ?Porton Down? Why are they not selling their test already? The ODX board are also getting very frustrated by the delays in tech transfer of the mologic lft. We formally started working with Mologic recently, but it had been going on for many months before. Of note we have improved the sensitivity of the AffDx test considerably in that time. Mologic must have been helping with this. I also can't really understand why, other than the UK diagnostics industry really are being collaborative and see the bigger picture of supporting each other will result in those companies all thriving. Mologic and Avacta will work together on a whole programme of other projects after this and maybe even the hybrid lft. As mentioned before, it is not a zero sum game.
Scaredy-cat - maybe.
GMCC - agree re the combined test, but that seems a little way off to me.
"Is anyone else confused by the Mologic agreement/relationship with us?"
Extract from RNS today :
" Mologic partnership enables near-term AffiDX™ CE Mark for Professional Use
Whilst the Group establishes its own ISO13485 accreditation, in order to achieve the fastest possible and lowest risk route to CE marking, Avacta has established a partnership with Mologic Ltd. so that the AffiDX™ SARS-CoV-2 Lateral Flow Rapid Antigen Test can be CE marked for professional use quickly under Mologic's established ISO13485 Quality System. The CE mark will then be transferred to Avacta when it achieves ISO13485 accreditation, which is expected at the end of March 2021. As part of the collaboration between the two companies,"
This bit interesting
"Avacta and Mologic are also exploring the possibility of combining Avacta's spike antigen test with Mologic's nucleocapsid antigen test in a single device which would be a world first and has the potential to deliver the most sensitive rapid antigen test possible. The two companies will evaluate whether the two tests can be combined in a single device and then make a commercial decision on whether to pursue this second generation COVID-19 diagnostic.
Avacta will immediately be able access initial manufacturing capacity through Mologic, in addition to scale-up manufacturing capacity with BBI and Abingdon Health. Combined, these manufacturing partnerships can scale up to several million tests per month and potentially much higher with further investment. Avacta is also continuing its discussions with other manufacturers in the UK and overseas in order to be able to access additional capacity to ensure that it can meet the expected demand "
"It seems they’re useful to us now because of their ISO accreditation which can accelerate CE and therefore commercialisation. But if that’s so, why didn’t we ask BBI to get the CE mark instead of a “competitor”? Perhaps they’re not a competitor??"
Could the Mologic agreement have something to do with Mologic's American presence? An old article, but it announces Mologic's expansion plans in the US.
'Not Currently on sale in the USA' springs to mind.
Is anyone else confused by the Mologic agreement/relationship with us?
-We’re told they’ve been collaborating for months - anyone know why?
-It seems they’re useful to us now because of their ISO accreditation which can accelerate CE and therefore commercialisation. But if that’s so, why didn’t we ask BBI to get the CE mark instead of a “competitor”? Perhaps they’re not a competitor??
-Mologic said in December that wider validation results for their test were expected to be available during Jan, but if they were, they weren’t published ( from what Ben says it seems they might get published next week). This “delay” coupled with the somewhat strange agreement to help us in between times seems a bit weird to me.
-Worth noting that the tech transfer to ODX of the Mologic test remains ongoing, and that until this week neither Mologic or AVCT had made any comment about either test going through PD, which again seems odd given that both companies were involved in “moonshot” from the outset after meeting BJ in August, and their apparent status domestically.
And then there was the ODX guy who, post the Mologic CE announcement, let slip he was working on the AVCT test...? Why would he be doing that...?
I just can’t square the circle in my own mind and do wonder whether there’s more collaboration going on behind the scenes between us, Mologic, ODX and perhaps others than we know. Might we get some kind of wider “collaborative”announcement about domestic supply of tests ready for 8th March to satisfy what moonshot was all about in the first place, ie bringing U.K. diagnostics together to drive a desired sovereign outcome?
This is probably all ****** and if so, please ignore!!!
@Robotics - It's not 100% clear from the conversation I had I'm afraid, but I get the distinct impression Porton Down are overseeing it as PHE are currently evaluating both.
And yes, that's my thinking - I think any British company which performs will get a slice of the pie as part of strategic state support to the diagnostics industry.
@benbenbenben do you know whether the field trials on the Mologic lft are being conducted by Porton Down or Mologic themselves?
Presumably it is not an either or decision for the government. If one or both tests meet the required standards, they will approve and buy one or both tests.
Apparently, Mologic will publish performance data on their field trials next week and Avacta are a little behind them - which supports the view we'll see the CE mark before the end of March, I think.
As Mologic and Avacta are the only two UK tests being evaluated at Porton Down atm, it should be quite an interesting few weeks... GLA
Courtesy it Myles...
“It is interesting to note that the LFT will be CE Marked by mologic, and then transferred into Avactas ownership once avacta receives its own ISO13485 accreditation, " which is expected by the end of March."
This quite clearly implies the LFT could be CE Marked BEFORE the end of March; elsewise why bother with Mologic CE Marking it first?