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"Colin King, CEO of Omega, commented: “We’re very pleased that the self-test usability study has completed and that
we are progressing towards our goal of MHRA approval for self-test home use. We cannot give a timescale for when
this might be achieved but we look forward to updating shareholders on further developments.”
(From the RNS on 7 September)
Self-test use requires MHRA approval. Professional POC use doesn't (as the test is CE marked and registered). The thing to remembers is that the Government is likely to order both types of tests for different parts of the five pillars.
It is highly unlikely that the Government would order self-use tests without MHRA approval, as that would open them to potential liabilities (there is no blanket liability waiver under the current coronavirus regulations). They've already ****ed up with some of the current tests and are facing legal action - they can't afford to **** up again.
Indemnity* insurers for healthcare providers - both NHS and IS - require use of approved tests. These can either be those that are CE marked and registered (i.e. the UK-RTC professional POC AbC19 test) or self-use tests that have been subject to MHRA approval (which will be the UK-RTC AbC19 self-use test).
But the key take away from this all is: sit back and stop worrying. All will fall into place in due course and we have an exciting few months ahead of us.
* please note that in relation to NHS activity, either from NHS or IS providers, the indemnity being referred to is public and employer liability, as clinical negligence** indemnity for NHS activity is covered by the NHS Clinical Negligence Scheme for Trusts. In relation to private clinical activity, either by NHS or IS providers, the indemnity will also relate to clinical negligence as this cover has to be privately procured.
** as healthcare providers are required to have Covid-safe processes, arguably issues arising from the use of non-approved tests could be argued to be clinical negligence.
*
"or...... shall I consider the anonymous BB poster who knows better.... hmmm"
Interesting... aren't you an anonymous BB poster who is proporting that he knows better as he has information from the company.
Discuss
I don't know better, I do know that the government can't be seen to send kits to homes that do not have approval from it's own body that is set up to do approval ! It doesn't take inside knowledge to recognise the absolute PR nightmare that could result in.
I still think it's an entirely point as we've been told MHRA is simply a document review (i.e. tickbox) exercise.
You just order them pending approval which is probably why BBI tweeted.
No approval, no pay for the ‘order’.
"I can answer one of those questions with absolute surety as it is a question I have asked of the company in the past.
No, the government order IS NOT reliant on the MHRA approval, that is a entirely separate matter."
You seriously think that the government is going to order products for home use that it's own regulatory body has not passed for home use ? Whatever the company said, it's the gov that makes these decisions. "Gov sends tests to household that are not approved by it's own regulatory agency", would make a lovely Daily Mail headline. Anyhow, assuming info on this board is right and MHRA approval is a paper pushing exercise, I can't see a scenario whereby approval would not be granted.
Lot's of misinformation being put out here. The track and trace app has nothing to do with the app that will be integrated into the RTC tests. The track and trace app will be rolled out tomorrow.
https://www.wired.co.uk/article/nhs-covid-19-tracking-app-contact-tracing
"Incorrect. All care homes must and will be registered. The owners of these care homes can then request tests on behalf of their staff, regardless of whether their staff are registered or not."
Wrong. CQC registration is *not * the same thing as registration as a healthcare professional (a registered healthcare professional is someone registered with one of the statutory healthcare regulators, e.g. the GMC, the NMC, the GPC, etc) . The CE marked professional use POC test can only be used by registered healthcare professionals.
Nursing homes are required to have registered healthcare professionals on their staff. Therefore, those staff will be able to undertake tests on colleagues and patients.
Care homes are not required to have registered healthcare professionals on staff if they are not providing nursing care (which the majority don't). Registered managers (who are registered with CQC) are not registered healthcare professionals unless they are also registered with one of the statutory health profession regulators.
Care home staff who are not registered health care professionals *cannot* administer professional use POC tests to colleagues or residents. They would be able to assist residents with undertaking a self-test, as and when self-tests are authorised by MHRA and the care homes are able to procure them.
My colleagues in care homes are telling me they are not currently able to access relevant tests and they have not been issued with clear guidance from HMG. That doesn't surprise me, as HMG have a habit of issuing guidance at the last minute and it being garbled nonsense.
"Incorrect. Abingdon Health are the only ones at this present moment manufacturing the ABC-19 test. If they cannot meet demands, then ODX will be called in to help out. You can email Colin for confirmation"
Colin confirmed to me the position I put forward earlier.
"Thanks again for repeating what I stated, Hospitals can order these tests through whichever supply chains they normally use."
I didn't repeat what you said. I pointed out you don't know what the actual position is. As some will be aware (if you look back at my posts) I was in a briefing with our pathology team yesterday... guess what we were discussing? Take a peek at the Health Service Journal as well.
"Absolutely incorrect. Pharmacy staff fall under key Health workers so are eligible for the test as well. They are not available to members of the public. This is clearly stated on Abingdon Health website. These Pharmacies have not received any orders asking them to hold off selling to the public. There are no tests available to the public as of yet."
You're conflating things again. I made no comment on who will be eligible for testing - I was talking about who was placing pre-order for tests. The large pharmacy chains are doing just that, as they will be offering professional use POC tests to the public. They've been asked not to roll those services out yet.
Shareinthis, the app could be kicked off for a trial period of course. We don't know. As Regulator says, it has already been extensively trialled on the Isle of Wight. But yeah sure they will roll it out in stages with a level of monitoring as they go. That would be my guess as an ex management consultant. The point is it will draw a lot of media attention to the mass testing strategy and the RTC's app will be linking into that at some point.
We don't know if MHRA approval will come before our app is ready or whether the orders for test kit will be announced on the same day. It may well be that the bureaucratic process (MHRA) is held back until the test kit is ready to go out of the door. Mass testing is now the number 1 political issue. They want to get it right don't they?
So some relevant factors are in the public domain. And some won't be- and those are for us to assess for our investment decisions.
"For 'professional use' means by a registered healthcare professional, where it falls within their sphere of competence. That would include doctors, nurses, dentists and pharmacists - it would not include those working in care homes unless they are also a registered healthcare professional".
Incorrect. All care homes must and will be registered. The owners of these care homes can then request tests on behalf of their staff, regardless of whether their staff are registered or not.
"As I understand it, all the UK-RTC manufacturing partners are currently manufacturing to enable them to deal with any government order and the professional use pre-orders currently being gathered on behalf of the consortium by CIGA".
Incorrect. Abingdon Health are the only ones at this present moment manufacturing the ABC-19 test. If they cannot meet demands, then ODX will be called in to help out. You can email Colin for confirmation.
"It's not quite that straightforward. Hospitals (in England) have been told that they should not ordering directly but via NHS supply routes... it's tied in with a somewhat bizarre instruction from DHSC about them not testing staff and patients (I know - bonkers!) GPs have been told something similar".
Thanks again for repeating what I stated, Hospitals can order these tests through whichever supply chains they normally use.
"The big chains (Boots, Superdrug, etc) will be offering professional POC tests alongside their other testing/vaccination services. They've been asked to hold off rolling it out at the moment".
Absolutely incorrect. Pharmacy staff fall under key Health workers so are eligible for the test as well. They are not available to members of the public. This is clearly stated on Abingdon Health website. These Pharmacies have not received any orders asking them to hold off selling to the public. There are no tests available to the public as of yet.
"Tricky.
As with the previous Test and trace app and failures will there not be a lapse period to see how this goes. Just because the App is launched surely there will be a week to see how it works."
The app has already been rolled out to select users (in the Isle of Wight, the London Borough of Newham and amongst NHS volunteers), to test its functionality. I understand that there have been some issues identified that have been fed back to the developers - and which have supposedly been addressed (not holding my breath though). I don't think anything will be allowed to hold up the much vaunted launch tomorrow - even if it doesn't work perfectly they'll push it out, otherwise it will be yet another private sector/government failure (to add to the catalogues of failures to date)...
Tricky.
As with the previous Test and trace app and failures will there not be a lapse period to see how this goes. Just because the App is launched surely there will be a week to see how it works.
Chill out. Nothing's happening here right now. there are enough moaners posting daily. A little light humour never hurt anyone. And sad, moi? Never. I'm invested in ODX!
For any new investors on here, please just be careful with some of the information you get on here. There are a lot of childish people on here. Just to give you an example, there's a saddo on here that just went through all the trouble of creating a new account just to be funny and just to get likes, that's the type of people you have on here. He goes by the name of smart alec. If you go through this thread and read the comments you'll realise just how sad he really is. SMH.
"For Professional use only means for doctors, nurses, dental surgeons, and people that work in care homes"
For 'professional use' means by a registered healthcare professional, where it falls within their sphere of competence. That would include doctors, nurses, dentists and pharmacists - it would not include those working in care homes unless they are also a registered healthcare professional.
"Abingdon Health are currently the only ones producing this test. If demand increases to the point where they cannot cope, this is when ODX will be called in to help out with manufacturing."
As I understand it, all the UK-RTC manufacturing partners are currently manufacturing to enable them to deal with any government order and the professional use pre-orders currently being gathered on behalf of the consortium by CIGA.
"The current tests for Professional use are not ordered by the Govt, they are ordered independently through Hospitals and the other Health care settings mentioned earlier."
It's not quite that straightforward. Hospitals (in England) have been told that they should not ordering directly but via NHS supply routes... it's tied in with a somewhat bizarre instruction from DHSC about them not testing staff and patients (I know - bonkers!) GPs have been told something similar.
At present, dentists and pharmacists are ordering. The big chains (Boots, Superdrug, etc) will be offering professional POC tests alongside their other testing/vaccination services. They've been asked to hold off rolling it out at the moment.
From what I gather from colleagues, care and nursing homes have (once again) been left in the dark about how they will access POC test - particularly if they have no registered healthcare professionals on the staff.
For new investors information. Mikodox told us all yesterday he'd sold and has subsequently been posting lots of confusing posts. When he gets called out for his behaviour he starts a lot of silly name calling.
For the record ODX are part of a government backed consortium. They have an MOU agreement with the government to produce and supply 100,000 antibody tests for the month of September rising to 200,000 for October. Additional capacity is available but that would be subject to a development of the agreement and it's extremely likely, a higher price.
Updates for the MHRA approval, the government order and other progress on another 4 new generation tests ODX are in partnership with Mologic for, are expected. The deadline for the RTC was scheduled for September. We are not late but it's likely that we are ready to go as soon as government make their move. The NHS app launches tomorrow.
I was under the impression that each member of the consortium had a role to play with either producing the test or distributing the test. I didn’t realise Abingdon Health was a one stop shop if you like. That just might need some ‘help’.
So you believe the only reason for the other companies in the consortium is to help with demand?
Ok, well BBI must be expecting that they can ‘help out’ too. As they’ve got numerous positions advertised all relating to the government RTC appose to work with the antigen LFT’s. https://bbigroup.peoplehr.net/Pages/JobBoard/Opening.aspx?v=7706bde9-1872-4972-b6ed-0ef9e0bab376
Motives change and so do opinions it seems.
"Now watch some smart Alec jump in and say that's not correct."
That's not correct.
(sorry couldn't resist the challenge)
Just to add people who work in Chemists and Pharmacies are also eligible for the test, but you won't see it on the shelves.
Block16legend -For Professional use only means for doctors, nurses, dental surgeons, and people that work in care homes. This excludes chemists and pharmacies. Chemists and Pharmacies will fall under mass testing. Currently orders for the ABC-19 test can be made through the Abingdon Health or Gov websites. Abingdon Health are currently the only ones producing this test. If demand increases to the point where they cannot cope, this is when ODX will be called in to help out with manufacturing.
Govt orders for mass testing will happen once the MHRA approve the tests for self use. The current tests for Professional use are not ordered by the Govt, they are ordered independently through Hospitals and the other Health care settings mentioned earlier.
Now watch some smart Alec jump in and say that's not correct.
Markets are down, we’re down, but fundamentals have not changed one iota and if people can’t see that and want to sell then up to them.
Actually, the fundamentals have changed, they surely improved and we will all be updated soon with an RNS of the good news
Ton1c, I sincerely hope there is a team working on synthesizing the type of test/register/opt-out (then what) type of system you mention. I sincerely hope this team has been working on this for months and that it's dependencies are (in the UK) the NHS T&T app, and an approved short list of Ab and Ag test strips which can be recognised by the app, and that this will be launched when there is capacity, both kit, and in the supply system (remember the delivery procurement contract?), and in the tech/database, for it not to fall on its asre on day one. Then we'll be sorted. However, I have a nasty feeling, with this gov't that they've just thought of this over their cornflakes this morning, and someone is just poking the press release for the NHS app tomorrow to talk about the roadmap for its better use in the future, as and when all these components actually do come together.
Some interesting thoughts indeed - i too wonder how integration could work in the app but have doubt it will be ready for this version release. Lets hope its on the pipleine - or even better - im wrong and its done. Being wrong will make me very happy
Thanks mate - I can be a little verbose. And yes - thats what i thought and why im confused by the current situation (and i think why we have a few negative comments here)
Im confident in where we are going but wish we would at least see the destination
Extending this question? Is the Government order reliant on MHRA approvals? If so why?
Surely thats for home use?
I would have thought - the Gov would want these tests controlled so they have full access to the results (which they wont get through home tests)
Surely these are best (for the gov) to be administered by professionals. And given their speed we could see a really quick turnaround if administered by professionals at testing centers
I understand some of the negativity here - its very frustrating. The gov seem very willing to place advance orders - i guess we'd all like to see these.
Dont get me wrong - Im 100% holding and my belief remains fully - this will be massive in both the covid and other product sales - once the news flow starts ad we will wish that could start when we were in upper 80s or 90s. Its just a long boring ride - we know the destination in a good one but the journey is not the best lol
Lots of wishful thinking, there's definitely some elephants in the room re orders. Still big upside her once they come, but elephant none the less.