Member Info for bakky

jamrock, no probs, each to their own. I am simply asking them for clarity which they so far choose to ignore. Not right imo.

Jamrock, what's the point of phoning. You won't get the hotline to anyone who matters and they can act with impunity on the phone. As I said, I prefer it in writing, that's what I was always told. What is the hardship with a confirmation email to clarify the position. I have been asking for over 3 months, and total silence. That concerns me, if you are ok with that then fine, I am not!

https://www.lse.co.uk/rns/AVCT/update-on-uk-availability-of-affidx-test-6l3s6gadd6ljqp6.html

in case anyone missed it. These had products selling just like Ygen's Clarigene PCR test. As you can see they have had to postpone/stop sales until they have need approved by the new desktop review procedure.
hTTps://www.lse.co.uk/rns/AVCT/update-on-uk-availability-of-affidx-test-6l3s6gadd6ljqp6.html

https://www.londonstockexchange.com/news-article/ODX/update-on-ctda-regulations/15197535

https://novacyt.com/wp-content/uploads/2021/11/Novacyt-Validation-of-COVID-19-tests-in-the-UK-under-CTDA-FINAL-ENG.pdf

Jonny, yes they will, but they will have to pass the desktop review first. Which is where Ygen's test is going through the process, but as yet not on the list. That is how I see it but could well be wrong. That is why I have asked for clarification, but they won't so I am concerned that's all. Did you not see the links to AVCT and NCYT where they have had to stop selling their own tests because of the new desktop rules. The whole UK diagnostics are up in arms because they saw it as favouring the Chinese and other foreign products and putting yet another hurdle in front of the UK companies.

Tony, can you explain why other companies like NCYT/AVCT and many others have had to postpone/stop sales of their own products until passed by the new CTDA regulations?

Tony, the contracts were for processing/testing/lab capacity, not for the Clarigene product. It is something different. Tell me why are they not on the approved list to sell this stuff? Not asking for much, just a yes, our product has been passed for sale in the UK.

jonny, have you seen the lists of approved products/companies?

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products

ISATONY.. it's every covid test PCR included. Also it's nothing to do with CE-IVD .

Jonny, it's all old regs.. The new regs are from Oct last year. All tests have to pass the CTDA desktop review. I just want to hear it from the company as it's a bit of a minefield with all the regs floating about.

guys, don't forget I am a lth here, and I am batting on your side. I have asked an important question and been ignored by the company. If that is ok with you lot then fair enough, but I want to know if the PCR test is lawful, and they can't or won't confirm it. What does that say to any of you eh? Instead of having a pop at me why don't one or two ask yourselves and see what happens. I will just say that the govt provides a list of companies/products that have been passed and are ok to sell in the UK. I can't find Ygen or Clarigene on any CYDA/Govt list. If you are happy blindly going along with it, then fine,..I'm not and want clarity.. The fact they have stonewalled and can't confirm sends out the wrong vibe to me.

Jonny, that's ages old. That is mainly for test processing/lab work anyway. I am talking about the newish CTDA regualtions that came in a few months ago for all Covid tests. ALL test/products have to be passed by the CTDA desktop review. As far as I can tell YGEN isn't on either of the two lists. I have simply asked the company the confirm their PCR test has passed the new regulations.. 3 months later I have heard nothing after repeated requests. I just think it's a bit dodgy and want to know if the test is legit...WHY don't they respond??

Stas, I prefer it in writing! They can act with impunity on the phone. Have experience of that..Sorry, but in writing every time for me . As the company/Walbrook won't confirm they are selling lawfully, can anyone on here prove they are? Sorry, but my questions to the company are very relevant and need answering. Why are they stalling, just ask yourself that.

GLT, . why won't the company clarify the situation? Not sure the surge contract has any relevance to the CTDA situation has it?
All I want is a simple answer, taken over 3 months so far...why?

I just want some clarity from the company. I first asked the question last Nov for heaven's sake. Silence so far, I think it's justified to have concerns as all the evidence points to them not being approved.

We can't find them on any approved lists so where do we stand? Other companies had to postpone their product sales until approval. NCYT had eleven products submitted and only two were approved. They are still waiting to hear about the other nine, and losing about £3m in the process.

How are Ygen allowed to carry on selling is my question? Looks like the company can't be arsed to reply, which maybe doesn't surprise me.
I will be asking all of their customers soon to see if they are happy with Ygen's product approvals. That will be fun as I expect they haven't a scooby either.

Ella, only validated products, Ygen's isn't. AVCT backs up what I am saying.. All products need to go through the new desktop system, doesn't matter when they first came to market.

CTDA had already approved some tests which they show (Ygen not included) . They also have a second (temporary protocol) list of products that can stay on the market until approved, again ygen not on this list either.
many companies like AVCT as you can see had to postpone sales of their unapproved products. My question is, does that same apply to Ygen and their Clarigene PCR test?
Nobody wants to tell me, if it's approved,...why not??

'' Only validated products, or products on the temporary protocol,
can be sold in the UK after 31 October 2021. The UK Health Security Agency has committed
to continuing its review of submitted tests and updating the CTDA register accordingly''.

Ella, so why can't the company simply say it? I'm still not sure what the hell is correct, so that's why I wanted clarification from the company.

Ella, at this time Ygen are not on either list, which to me means they can't sell their tests until approved! I have simply asked the company for some clarification some 3 months ago and have been largely ignored and given the silent treatment;

''The mandatory CTDA guidelines require all suppliers of COVID-19 tests (polymerase chain
reaction and antigen/lateral flow tests) to submit data on their tests for a desktop validation
if they wish to continue to sell them in the UK. This legislation does not apply or affect any
sales outside the UK.
On 20 October 2021, the UK Health Security Agency issued a list of products on the CTDA
register that had so far successfully completed CTDA desktop review and been approved. A
second list, the temporary protocol, was also issued detailing products which can remain on
the market whilst validation is being processed with an extended deadline from 1 November
2021 to 28 February 2022. Only validated products, or products on the temporary protocol,
can be sold in the UK after 31 October 2021. The UK Health Security Agency has committed
to continuing its review of submitted tests and updating the CTDA register accordingly''

Ella, the govt put in a new layer of accreditation (desktop review) that just about everyone has to go through. There were a few exceptions like some Chinese companies who's tests were already being used, but as far as I know Ygen wasn't one of them . There is also another list that have until the end of Feb I think it is to get approval, not on that list either.
For whatever reason if they do have the correct approval, then why not tell us?? That's my problem, they can't or won't.

you would think that is the case, but the silence is deafening!!