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“ but given the requirements for CE approval in EU have not changed, it was merely a formality for them to get the test restamped in EU as CE approved.‘

The requirements have changed. The EU are moving to the new 2017 Medical Devices Regulations (fully effective 26 May 2021). The U.K. hasn’t implemented those, due to leaving the EU.

During the transition period, CE marking under the pre-existing Directive (the 1993 Directive as amended in 2007) was acceptable - and that is the basis the AbC19 test was CE marked - but, if the devices were not offered on the European market by 31 December 2020 (which they weren’t) that provision would lapse. Abingdon would have to apply afresh under the new Regulations.

From an EU market access perspective, this is important news.

They can’t as they’re ruled out....

I’d agree with you, except for this bit:

“ The CE requirement for the EU is exactly the same 1st jan than at 31st of dec, so its no news that the test still has CE approval for professional use in the EU, applying in malta was just a rubber stamping process. and "continues to liaise with customers and regulatory authorities in other international territories" is hardly price sensitive info.”

This is not quite correct. Although the AbC19 test has been CE marked, it has not been/will not be offered on the EU market before 31 December 2020 (as the U.K. is no longer an EU member state). This means the current CE marking would lapse in 1 January 2021, when the transition period ends. The current CE marking would only remain valid if it had been offered on the EU market before 31 December.

In order for the CE Mark to continue to be valid from 1 January 2021, the test had to be registered with an EU competent authority before 31 December 2020, otherwise Abingdon would have had to apply afresh (as a third country manufacturer) for CE marking via an approved body and for registration with a competent authority in an EU member state. That would be a more complex/costly process than the one they’ve undertaken.

“ Regards volume, I had an email from CK a few months back saying that the consortium will be considering further outsourcing production. This could tie in nicely with ODX's links to India. Pune maybe?”

ODX doesn’t have any manufacturing capacity in India any more... they got rid of it.

I think it’s a holding procurement whilst alternative antigen tests (including Mologic’s) are being assessed by PHE at Porton Down.

It’s looking for diagnostic (antigen) LFTs. Looks like a holding procurement (perhaps whilst the Mologic test is assessed by OHE at Porton Down)....

“ Abdx will have very few followers imho, the spread is ghastly....12k volume.”

Yeah right.... the lead company for the UK-RTC, which holds/will hold the contracts with HMG and third parties for the AbC19 test isn’t going to do well. :rolleyes:

* ‘all’ - not ‘it’

“ 27 territories ie EU is just one therefore 53 countries, in the meantime more profitable LFT antigen test imminent”

The EU isn’t one territory. We cannot assume that it EU members states will purchase this test.

There’s no need to overhype this. What we do know is that at least 27 countries are currently involved in discussions ...

“The uk will have vaccinated the vulnerable by spring.”

Don’t bet on it. Simon Stevens is saying that by late spring he expects the NHS to have offered vaccinations to all vulnerable people. The key word there is ‘offered’. To date fewer, in some areas fewer than 25% of those offered a vaccine have actually been vaccinated. This is why the timetable is constantly being revised.

“ Seems to me there's an implied message to the MHRA & UK Gov in there - either get this approved for self test and ordered or we'll start selling it to others.”

They can’t sell to third parties without DHSC permission until 15 February 2021 - which will soon be upon us. The fact that Abington has registered the test with an EU competent authority is a clear indicator that they intend to sell to third parties when they can.

This bit of Abingdon’s RNS is interesting:

“ For example, to allow the continued validity of the current CE marking post Brexit, Abingdon Health, as legal manufacturer via its agent, has successfully registered the AbC-19 Rapid Test with the Maltese Medicines Authority. This means that the CE mark, for professional use, will continue to apply across the European Union after 1 January 2021.”

Because the government has first refusal until February, and DHSC permission is required for third party sales, the UK-RTC hasn’t been able to put the AbC-19 test onto the EU market prior to 31 December 2020, despite it being CE marked. This means that they’ve had to register it in an EU member state in order to supply it to EU customers post 1 January 2021.

Oh the joys of Brexit...

This is ELISA testing - as tecbadger says, quantitative.

“ Regulator would we require an additional MHRA approval? I’d assume so? Nice to see you still around been quite this week.”

Antigen testing will be professional POC use/screening use only. It won’t be available OTC in the short term.

I would expect MHRA EUA to be forthcoming quite quickly following TT and CE marking.

Been busy this week... there’s a bit of a pandemic on. ;-)

“ We were waiting for Mologic to CE mark. Now they have CE marked. We don't have to CE mark again gk47.”

Yes, they do. ODX will be a new manufacturer and will therefore need to independently CE mark the test before marketing it under the Visitect brand. The RNS confirms that.

“Mologic CE marked the antibody test in October I think? ODX have branded that test Visitect Omega and they may do the same for this test. We'll soon find out.”

Mologic CE marked the triple antibody test in June (not October) - https://mologic.co.uk/mologic-ce-marks-professional-use-rapid-diagnostic-test-for-covid-19-and-begins-manufacture/

ODX re-CE marked the Visitect version of the triple antibody test on my birthday in September - https://www.omegadiagnostics.com/Portals/0/200903%20-%20CE-Mark%20for%20Mologic%20COVID-19%20antibody%20test.pdf

If you don’t understand the basics of the approval process for medical devices, should you really be investing in a medical devices manufacturer?

“ Tricky...you need to have words with Colin king. As per my post earlier today, odx needs to CE mark their own test, and Colin king just reconfirmed that. Get on the phone and tell him he is wrong”

You are correct. ODX will effectively be a new manufacturer and will therefore have to undertake a further CE marking process for this antigen test, just as they did with the antibody test. I’d suggest that will happen first two weeks of January, as the TT process has been underway for a while.

If you look back, I was warning people about making defamatory comments. The BoD has to act in such circumstances.

Those making stupid, ill-informed and defamatory comments on social media are the ones to blame here. They’re damaging the company - and, in so doing, devaluing it.

“ Sell up then Sileng. If you are not content with your investment. This isn’t a get rich quick overnight stock.”

He can’t sell what he hasn’t got...

"The whole world is being tested and will continue to be tested were does it say we have sold any tests schools being tested not our test we have not got orders but wait order coming £2 £3 coming 60p would be nice"

Pardon?