Member Info for RegulatorUK

"Where did the 5 minute time frame come from previously? Does this make the 10-15 minute mologic test the fastest?"

I think some people, particularly the Avact-olytes, get confused about what tests have what parameters/performance. I don't believe Avacta has ever really claimed their antigen test would have a 5 minute result time. Looking back at the various RNS, what is noticeable is a lack to time-related claims.

BRH/Paraytec are the ones working on a 5 minute antigen test.

"but also the news that AVCT have made significant progress with their test, as per the following:"

That doesn't signify that Avacta has made 'significant progress' with their test. What this morning's RNS from Avacta makes clear is that it'll be at least another month before any final validation and CE marking - assuming they pass the audit... and that's before anyTT tht would be required for other manufacturers (aside from Mologic).

"If we can get them ready then we should be able to short-circuit the usual procurement process with NHS. They need our masks ASAP.. as do airlines to promote safe travel...schools...."

No, we won't.

(1) The NHS can only purchase medical devices that are CE/UKC marked. That has not happened yet.
(2) The masks that have been pulled are FFP3. What we are offering are FFP2.

"The biggest gains I have had have come from being patient and holding where I believed in the company."

This! 100% this!

"Could this jeopardise things?"

Not really.... it's a prototype that hasn't undergone clinical trials yet. By the time it's got through clinical trials and validation, you're talking the latter half of 2021 at the earliest.

The key thing about the Avacta RNS is that it provides some clarity about where its test is at...particularly the disclosure that the earliest it could get a CE mark for its test from Mologic is the end of March - if it passes the ISO accreditation audit.

This has been (some might suggest deliberately) vague in previous Avacta RNS'. What it clearly shows is that Avacta is still playing catch up with other firms.

Whether the Avact-olytes will comprehend this is another matter...

It doesn't omit the data (which isn't its data by the way) - it reproduces the ABDX RNS in full at the end of the ODX RNS.

What was interesting on the Avacta RNS was the disclosure that the earliest it could get a CE mark for its test is the end of March - if it passes the ISO accreditation audit.

What's the initial L2 for Abingdon (ABDX)?

"I think today is going to be better day for covid sticks as everyone ish got RNS’s"

I quite like the idea of Covid sticks - something you can poke to trolls with....

Which will be the first troll to comment?

Very positive news from the UK-RTC. I can see overseas sales (in countries that actually follow the science) benefiting.

Very positive news from the UK-RTC. I can see overseas sales (in countries that follow the science) benefiting.

"...that has to happen within 30 days from when we the agreement was signed is my understanding Hope this helps"

That's not quite correct. The trigger is contract award rather than contract signing.

A Contract Award Notice must be published 20 days after the standstill period expires (subject to no challenge being raised) where a standstill period applies (which is in most cases). The standstill period is 10 days from notification of contract award to the bidders. So that gives the 30 days that has been quoted in the media and in court.

Where there is no standstill period, the requirement is 20 days from notification of contract award to the bidders.

(Paragraph 9.1 of the 'Publication of Central Government Tenders and Contracts' guidance note if anyone is interested).

Same here. Recouped my investment yesterday and, despite this morning's fall, the remainder is still +251.75%...

"I know but the question was if it needed a CE mark."

If it was produced and marked *before* the end of the Brexit transition period (e.g. the Mologic antigen test) then it *will* require a CE mark, as UKCA marking came into force from 1 January 2021.

CE marking can also continue to be used instead of a UKCA - within the UK - until 31 December 2021 (with the exception of some devices that can only be UKCA marked). But any CE mark that is applied by a UK manufacturer after 1 January 2021 will only apply in Great Britain (see below) - it will not be valid in the EU unless also registered with an EU competent authority.

The reference to 'Great Britain' is also important, as these further transitional provisions exclude Northern Ireland - and what happens for medical device manufacturers there (including LFT manufacturers) is a whole different complex dance...

As said elsewhere, Covid-related stocks across the board are bouncing around following the PM's road map announcement, which was predicated on vaccination progress. As Reckoner says people are thinking that the need for testing - and more rapid testing - is diminishing. It's not.

Let's be honest about the vaccination process. As of close of play yesterday, only 624,325 people have been fully vaccinated (i.e. had the two doses as per the manufacturers' requirements) in the whole of the UK. That's c. 0.93% of the population.
Once you start to dig into the data you begin to see how shaky the current reliance on vaccination as the basis for reopening is. It's only one strand of a required multi-strand approach, which has to include widespread testing, tracing and infection management. Which we're not getting messaging about at the moment.

The requirement for testing is going to be with us for a very, very long time.

"The UK doesn't need a CE mark if id it sold within the UK."

Hmmm... not quite. The UK requires a UKCA mark or, in certain circumstances, will accept a CE mark where the device is registered with an EU competent authority (the latter bit being a further transitional provision).

"Actually bakky I don't think it does require a CE mark that has already been awarded, not sure TT has an effect on that, either way it's detail in the grand scheme of timing."

The Mologic antigen test has been CE marked by Mologic. However, it will also need to be UKCA marked by ODX in order to sell under the Visitect label.

As we are post-Brexit transition period, ODX could also CE mark it by registering it with an EU-based competent authority as well as the MHRA (as the UK-RTC did with the AbC19 test using the Maltese CA). But it cannot be CE marked without an EU-based competent authority's approval.

I should point out that quarterly reporting is not mandatory for most UK-listed companies - BRH does mid year and annual reports.