We spoke to new Sterling Energy CEO Tony Hawkins about the latest changes happening at the company. Watch the full video here.
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For info, Healgen one of 3 tests approved in Germany for home use.
And on that topic, if the test is of the same quality in terms of achieving the same S/S of 97 and 100 as in initial trials then we have to achieve less than 9% of the market in Europe to match the U.K. (pop of 770m vs 65.) completely bypassing the bureaucracy of the UKGov.
Been very quiet trust all ok
You do write well.
Nice summary. Especially the first point.
“With all this in mind, for a rapid antigen test to have clinical utility (and therefore sustainable commercial value) it should be able to detect SARS-CoV-2 viral load of a few hundred pfu/ml, or Ct of 25 or below, or >10,000 genomes/ml. Clearly, the lower the detection limit the better, and a test must be able to achieve this limit of detection in real patient samples and not just in contrived "clean" laboratory samples.”
Is that 2 fingers to Porton Down?
Secondly. It’s plainly obvious that we are going to get a CE mark before the end of March....
“The second and final audit is scheduled for March 2021. A positive outcome of the second audit will lead to ISO13485 accreditation. This certification sets the organisational and operational framework for all current and future diagnostic product developments and it is an essential accreditation that underpins future commercial success.
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.”
End of March is 5 weeks away. So we should have a CE Mark via Mologic within that time frame. As has been pointed out, if we’re looking good for the 31st, why get Mologic in? So it must be a LOT sooner.
In that window we will get the results of the quality of the BAMS assay.
“BAMS assay protocol has been simplified and amended to fit into the clinical work processes and the Group is working with its collaborators to determine the sensitivity of the BAMS assay when run on the type of mass spectrometers that are predominantly installed in hospital laboratories.
This evaluation is expected to continue for another two or three weeks and the Group is establishing outsourced manufacturing capacity for the BAMS tests in collaboration with Adeptrix so that it is in a position to formally validate the diagnostic product as soon as possible. Avacta is also in discussions with a large commercial partner to provide a route to market for the BAMS assay.”
So there’s literally this 5 week window of news coming up. Why the fudge would you sell out now? Especially if you’re a LTH.
I see Abingdon were up a bit today, sure that wasn't due to the pointless antibody test.
Well played the leech has gone :)
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.
Yes on the app Matt. But if you are being creative there may come a point when venues keep a small stock for folk who spontaneously turn up e.g. to get in the cinema or theatre etc. People would probably have to pay extra for that though
Scaredy-cat - maybe.
GMCC - agree re the combined test, but that seems a little way off to me.
I like this paragraph, if you can’t work from home come in and work.
We have the best test in the world and we know it works, staff can take one on arrival, lunch and take one home test your spouse & kids Work Rest and Play........
During the pandemic, in order to maintain a COVID safe working environment the Group has not been able to have all laboratory staff on site at the same time and has worked two teams. New CAT 2 laboratory facilities in Wetherby have been completed and equipment that has been installed is now being validated to satisfy the requirements of ISO13485. The new facilities will house about 20 staff and the Group expects therefore to be able to get all staff who cannot work from home back on site from February.
"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 "
Seems we wait a year and all our news will come at once
--BAMS (mid to end March)
This evaluation is expected to continue for another two or three weeks and the Group is establishing outsourced manufacturing capacity for the BAMS tests in collaboration with Adeptrix so that it is in a position to formally validate the diagnostic product as soon as possible. Avacta is also in discussions with a large commercial partner to provide a route to market for the BAMS assay.
--- ISO accredited (end of March)
The Diagnostics Division has established a Quality Management System and the first external audit by the Group's Notified Body (BSI Group) was passed in December successfully. The second and final audit is scheduled for March 2021. A positive outcome of the second audit will lead to ISO13485 accreditation. This certification sets the organisational and operational framework for all current and future diagnostic product developments and it is an essential accreditation that underpins future commercial success.
---LFT SALES (End of March)
As stated above, on the basis of these excellent initial data, the Group will now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year.
"Why are we bumping?
Need some more attention?"
Need a cheaper buy in - f*ck off!
Back to capacity... Even with another x2omega type supplier (c. 2x 2m per week) you are still 10m short.
I simply do not see how the government can therefore plug the gap without avacta.
Surescreen (500m @ £25 per test with option to extend) but again, nothing like the capacity required to hit the PA consulting target. And likely too expensive for true ‘mass’ testing.
I suspect the latest pivot by avacta has something to do with the government not announcing their ‘ready set test’ as early as thought.
I note this from politico on Monday (day of big reveal):
“TESTING TIMES: The Times’ Henry Zeffman got the scoop on plans to ramp up mass testing last week — but testing is oddly missing from Downing Street’s overnight trail and the reports in today’s papers. A Whitehall official fills Playbook in on some extra details: Ministers want ITV stars Holly Willoughby and Lorraine Kelly to be the face of a new public information campaign urging people to get tested, along with big media campaigns from the Sun and Lad Bible.”
Now, it seems the plan is to release the testing campaign a little later than planned. It’s all gone very quiet.
But to repeat, the numbers hoped for are impossible (from the U.K.) without BBI, Abingdon and GAD.
Now ask yourself why on earth would mologic/GAD sign up to give avacta capacity (whose strategy is now a professional CE use in *Europe*).
Mologic, to my mind, will not want to get on the wrong side of the U.K. gov/DHSC given funding opportunity. Therefore, for them to pivot to avacta is hugely significant and dare I say, not appreciated by many investors speculating on the likelihood of the LFT success. They are giving up capacity *and* use of their ISO accreditation. There is * no way* a company like mologic would do this if a) they had a better product b) they were not highly confident in the LFT.
In summary, as I said earlier, I’m convinced that avacta got fed up of process (we know they aren’t a fan of condor/Falcon) and decided to plot their own course.
They have been (very sensibly) cagey around the porton down process as, I am convinced, once CE marked they will say ‘do you want to buy them?’... if not, hello EU commission? Fancy a chat?
They are ‘still in dialogue with DHSC’... we know PHE are testing whether it works with other variants... but to my mind, this is very shrewd (and probably a combination of avacta getting a bit fed up with process).
A rationale dissection of all the facts - which we now have following the detailed rns- means avacta was ( pro my mind) intended to be front and centre of the sovereign test but given the Gov never funded up - we were/are free to flex our commercial muscles.
I still think DHSC are the most likely (big) first customer. We are a U.K. company after all but we have options and that is vital. DHSC will disregard *all* process to fund a reliable LFT. We know there is 7billion pounds waiting to be spent over a c.2 month period.
What are you on about? I’m moving sang down the list.
What has struck me as very odd recently is how the narrative (pre roadmap announcement) was all around testing. We even had the new strap line leaked ‘get ready, test, go...’ months of speculation around a sovereign LFT being produced.
We all know how much emphasis the gov has put on communications during the pandemic. Their strap line is therefore important. Putting testing front and centre for this was/is obviously significant. Without rapid testing it will be rockier to say the least. We need it. Every country does.
A few things I found odd, but now make a little more sense following the latest RNS:
We have not taken a penny of government money to date. Feels significant in terms of bargaining power.
Lots of chatter around how surescreen and mologic have had their manufacturing funded in part (you have all seen the bid stats contracts). It’s therefore a little odd (to say the least) to think the government did not have avacta front and centre when they were evolving the PA consulting strategy.
I’m even more confused how avacta fits into the PA consulting document now (2m per day by mid April) but what I do know is avacta have gobbled up the lion’s share of U.K. LFT manufacturing capacity. With mologic (and GAD) coming on board this has grown even further. Several million per month sounds odd to me. There is a reason avacta are coy about specific capacity imo.
The reason: I don’t think that the Government can hit their 2 million per day target, manufactured in the UK, without using Avacta capacity.
This creates an issue (and a serious one) for the U.K. gov. They stopped buying innova (granted they can probably restart but press would be dire) and now, seem to have omega signed up (2m per week by April) and who else? If this was down to process at Porton Down (which approved innova) and we go on to prove it a success in a *real world* trial questions will be asked.
"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.
Why are we bumping?
Need some more attention?
Just report as disruptive.
My thread full of green boxes and I know it’s Sang.
If everyone reports like we did this morning to that stupid Old Git Admin will take him out.
The Group continues its commercial discussions with potential customers for the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test and expects demand to be present for rapid testing for at least two years and probably for longer. Only by having a high-quality test that identifies the majority of infectious individuals can this clinical need be translated into commercial success and the Group believes that the recent initial clinical data are extremely encouraging in that regard.
hint hint sang....