Member Info for RegulatorUK

The Visitect tests are CE marked for professional POC use. They're not approved for self-use.

"The site has been updated on the 1st October, its based in Ontario - Ottawa, Canada. I sent them a mail, see where they are shipping from."

Dante Labs is an Italian company, with labs in Italy (in L'Aquila) and the US.

"Just hoping Colin has not had his kilt pulled down here"

Surely a kilt gets lifted rather than pulled down?

Immensa is basically the UK front for Dante, offering a range of testing. I'm not clear whether the actual testing takes place in the UK or Italy - the web-site isn't clear, but there are potential regulatory issues I may have a pick at...

"It's relates to self harm practised by Opus Dei a sect of catholic church, normaly referred to at extremists"

No really, although some members of Opus Dei may practice it. It was/ common spiritual discipline across a range of religions, including Christianity, Judaism and parts of Islam.

Opus Dei isn't a sect either - its a prelature. Despite all the conspiracy theories around it (I blame Dan Brown) it's hardly a secret society...

"@RegulatorUK - Are you serious with this question ?"

I wouldn't of thought so, I jsut wanted to see if you had a sense of humour."

Yeah, sure you did...

"Grasshoppers "-@RegulatorUK - Is there anyone else who can manufacture for Abingdon? If not, do you think ODX have a contract in place/or talks to manufacture all of Abingdons orders?"

Are you serious with this question ?"

It does make you wonder, doesn't it? Are people really investing in a stock without understanding the basic set up for one of its major product lines?

"You are such a ramper :)"

Soz... I shall go and flagellate myself accordingly.

"The presentation and trading update is next Wednesday?"
"And its next Wednesday don't forget. Not today."

I know that. I just have a good feeling about today...

"Why the Government have gone down this route when we have home grown products is not particularly clear to me."

We don't have sufficient capacity for PCR testing and there's a shortage of both testing kits and reagents. The government are procuring where they can.

It would have been more sensible for the government to have sourced these through a more established company (who could have sourced them I'm sure) - it's daft to order via a company with no established record. I've flagged it to Jo Maugham at the GLP in case they're interested in taking a look.

This order won't impact us though...

"Regulator, agree that Abingdon's tender has been accepted, in simple terms, apart from ODX, who is connected to Abingdon for the mentioned antibody tests?
Again in simple terms, why does this information does not need to be in your words "basis for derogation from the procurement regulations""

Sorry - I'm not quite sure what you're trying to say...

...will be a good day. I've got a positive feeling this morning.

"The fact is that Abingdon Health HAVE got £75 million for Antibody tests."

No - they've got a call off Contract for up to £75 million.

"This is a follow on from ODX's first order."

No - it includes the first order for 1 million tests, which was an order for Abingdon Health - not ODX. That was made clear in the communication from Walbrook.

"Links on the tender document inform that in the case of an epidemic or emergency, an RNS or informed consent is not needed.
They also go on to say that the tender is based on the best price offer from Abingdon."

The links in the tender say nothing about RNS. They explain the basis for derogation from the procurement regulations. They're nothing to do with RNS requirements, which are obligations under a different set of market regulations and which apply to only to ODX - not to Abingdon (which is the part to the Contract).

Pillar 3 and Pillar 4 is where the demand for UK-RTC tests will be the greatest. That's what we want to hear about...

"He just mentioned an announcement on Friday regarding testing in care homes could this be part of the 75m?"

It's Pillar 1 testing, so unlikely to be antibody (although it would make sense to do both in care settings). I think it'll be a boost in access to antigen/PCR testing for care homes, which has been patchy (to say the least) to date.

"... I guess we can just dispense with rules if Boris doesn't want them to be obeyed."

Referred to in Whitehall as the 'Cummings Clause'.

"Maybe the Govt' don't want the home test kit in the public domain yet until track and trace or some useable app is available to record and give credibility to the test. Maybe overthinking it but hey ho, we live and wait."

I think there is something in that. Pillar 3 roll out is definitely not as far forward as it could be...

"Does that mean MHRA approval could potentially be held back?"

I doubt it. DHSC will want MHRA approval to roll the tests out for Pillar 3 and Pillar 4 use.

My view is that it is a call off Contract (not a framework agreement as has been suggested elsewhere*).

The procurement itself was not divided into lots (i.e. different parts aren't split between different providers) and that's what the reference at II.1.6 is.

I think there is a question as to whether there should have been an RNS back in August, when the award was made. I'm assuming ODX will have taken advice, given the complexities involved.

*A framework agreement would normally cover multiple providers and be used by third party commissioners to undertake mini-competitions or direct awards to those providers included in the framework. The current £10 billion NHS England 'Increasing Capacity Framework' tender is a prime example.**

**Although its one of the most over-engineered procurements I've had the 'pleasure' of dealing with.

"Where have you git 44% from? As far as i understand there are 4 members within the RTC and based on the recent contract sign each get an equal share - 25 % - so 25% of £75 million . Thats just the share of RTC antibody kits. We also have Mologic - CD4, Food intolerance and of course - when it comes mologic antigen"

The DHSC Contract with Abindgon Health indicates that up to 44% of the provision can be sub-contracted.