Member Info for RegulatorUK

"The avacta fan boys are here today as they are concerned we have a deal signed before them. Its actually not surprising because if I worked for a distributor/ healthcare body the first thing I would want to see would be validation data by third parties. Mologic have FIND a highly reputable independent party globally. Avacta don't even name their validation partner (highly suspicious)"

Very well put tecbadger...

"I thought Dam partnership released 1/11 ?"

You are indeed correct.

I do also suggest that people read the CTDA Regulations. They're not very long and quite self explanatory (if you understand the structure of these types of regulations). They can be found here: https://www.legislation.gov.uk/uksi/2021/910/contents/made

"Omega clearly asleep releasing the same RNS as Novacyt and Avacta 24 hours later."

I'd suggest more a case of ODX having to respond (once again) to misinformation being shared by people trying to manipulate the share price....

"Omega submitted before 1st October
Avacta submitted before 1st September"

Where does the RNS say that Omega submitted before 1 October? It simply says that it submitted the before the final deadline of 31 October 2021 (which is the correct deadline, unlike the suggestion in the Avacta that the deadline was 1 September - it wasn't).

Why are you making things up?

"Good luck with that flimsy external validation data"

*Snork*

Norty tecbadger...

"Ps the gov and DHSC have got no idea for they are fcking doing either.."

Yebbut... our lives would be a bit boring if they did. ;-)

"Don't forget UKCA regulator ! It's going to be a fun few years for the IVD industry

And by fun I mean like putting needles into your eyes."

This sort of stuff does keep me employed... ;-)

"It is a bit confusing having two lists of tests, yet that not being all the tests that can be sold - you would have thought that having one version of the truth would have been simpler?"

The problem is that you will get these sort of anomalies if you change authorisation processes in the piecemeal way that the government has. This is a good case study on incompetence...

EDIT: In fact, you're going to end up with at least* three lists:

- those tests the CTDA doesn't apply to;
- those tests exempted under CTDA (which is different from the CTDA not applying); and
- those approved under CTDA.

And top of all this, we also have the new MDR tribulations (as outlined here previously by @tecbadger) to look forward to.

*I'm assuming, in the interests of public safety DHSC may also publish a list of those who were not authorised under CTDA, and those whose authorisation has been withdrawn, in a similar way to the FDA or the EUMA.

"dont say you were not warned. Will stay away till news comes out and then those who have called me a troll can apologise."

Off you pop then, Chuckles. Don't let the door hit ya where the good Lord split ya...

"It is a bit confusing having two lists of tests, yet that not being all the tests that can be sold - you would have thought that having one version of the truth would have been simpler?"

The problem is that you will get these sort of anomalies if you change authorisation processes in the piecemeal way that the government has. This is a good case study on incompetence...

"If you understand the legalities, perhaps you might want to refrain from commenting and making yourself look (even more) stupid?"

That should, of course, read: "If you don't understand the legalities..."

"So is Visitect on the government approved list?"

It doesn't have to be for the professional POC test, as the CTDA regulations make clear.

If you understand the legalities, perhaps you might want to refrain from commenting and making yourself look (even more) stupid?

"I think I remember you mention the Marketing thing before - isn't that where you can have a CE mark, but until you are allowed to Market, you can't sell? I think that is supplied by DHSC isn't it?"

Pre-CTDA the process was:

- manufacturer or Notified Body CE marks IVD (generally only for professional POC unless one of a small group of self-use IVDs identified in the MDD/MDR regulations
- manufacturer notifies competent authority of CE marking and applies for marketing authorisation (in the UK the competent authority is MHRA)

When it came to Covid, you could not CE mark an IVD for self-use using the above process. Further authorisation was required from the competent authority. In the UK this was being done via Emergency Use Authorisations and the Porton Down assessment process.

The CTDA is intended to replace the Porton Down process and provide a clear statutory basis for marketing authorisations in the UK of Covid IVDs going forward. Bascially the SoS/DHSC will nominally manage a process (undertaken by HSA and MHRA) for market authorisations. There also remains the capacity for exemptions.

"The personal attacks are not warranted when I am simply stating facts as i see them."

You're not "stating facts" - you're giving your opinion...

...an opinion that appears to be based on a lack of understanding of the facts.

"They said y'day that they had an Initial Purchase Order for £750k..that still stands despite your efforts."

Yep.

I'll just repeat for the hard of understanding.

The CTDA Regulations *do not* apply to the Visitect Professional POC test, as it was CE marked and had market authorisation prior to 1 September 2021. It is that Professional POC test which is being sold to DAM Health at this time.

The CTDA Regulations *will not* apply to any test selected by the government for supply under the DHSC contract.

"Agree - requires clarification have Omega submitted desk top application at PD?

I could be wrong here and this is a total guess but I wonder if the BOD are expecting HUA EU within days and are holding out ?

Could be?

There's no requirement for ODX to clarify anything.

"WRONG
ODX test cant be sold to DHSC as it didn't pass Porton Down as its the Mologic test."!

What on Earth are you on about? Porton Down is irrelevant.

You clearly have no understanding of the legal requirements.

Wessley...

I suggest you try reading what the CTDA Regulations actually say.

Not all tests will require separate approval. As per regulation 34B, the CTDA requirements in Regulation 34A will not apply to:

" 1. ... a coronavirus test device that is placed on the market or put into service only for use by—
(a)the Secretary of State;
(b)a devolved public health body; or
(c)a health service body supplied pursuant to an existing contract.

2. ... a coronavirus test device that is supplied to—
(a)the Secretary of State;
(b)a devolved public health body; or
(c)a health service body pursuant to an existing contract."

Therefore, the CTDA requirements will not apply to those tests that may be provided under the terms of ODX's Contract with DHSC (whether professional POC or home use).

Moreover, Regulation 34C says:

"(1) The requirements in regulation 34A do not apply in respect of any period before 1st September 2021."

This means that any test which met the requirements for CE marking and which obtained marketing authorisation on or before 31 August 2021 will not be affected. These will primarily be professional POC tests - including those that will be supplied to DAM Health by ODX under the current Heads of Terms announced yesterday.

Basically, the CTDA requirements will only apply to tests that had not received marketing approval prior to 1 September - whether professional POC or home use. There are some transitional provisions in relation to the period of 1 September - 31 October outlined in Regulation 34C but they're not really relevant to ODX (although they clearly were to NCYT and Avacta).

DHSC has published the names of the first batch of tests to be processed and approved under the CTDA. They've also published a list of tests that have been given further derogations/exemptions - these are primarily tests that have not completed the standard CE marking and market authorisation process, but that were given EUA.

At present, there is nothing to stop ODX providing their professional POC tests in the UK. As and when they may get HUA in the EU, then they will need to apply under the CTDA but that will relatively straightforward.

There's no need for ODX to RNS anything at this time.

"Twatcher - didn't think i would be saying this - as many know I have been a long term supporter of this stock.
However you are correct, and the facts are the facts."

TWATcher wouldn't know a fact if if bit him in the @r$e...

I think it's rather pathetic that the usual suspects are trying to suggest that somehow ODX has missed the ball on the new MHRA requirements. One thing we know is that CK and the team are all over it when it comes to regulatory requirements.

ODX will need to register the Visitect test. What they don't need to do is RNS the fact that they have done so, as this is simply a 'business as usual' process.

Avacta and NCYT have RNSed as questions were raised and, frankly, they haven't had a positive RNS in a while.

Unfortunately, this seems to have fired up the bottom feeding trolls on here, as attested by the sea of green boxes. Just ignore them.