Member Info for RegulatorUK

"It’s not misleading. It’s factual."

It is misleading. CE marking does not enable it to be used in the UK as the RNS implies: "...the AffiDX® SARS-CoV-2 antigen lateral flow test has received a CE mark for use as a consumer self-test in the UK and EU."

Under UK law it must pass the CTDA assessment. At present, it hasn't. If it had, then you would expect the RNS to clearly state this. It doesn't.

"Wait, what? Can we sell to Joe Public in the UK now or not??"

No.* The RNS is misleading.

*Unless we have also passed the CTDA process, which the current list (https://www.gov.uk/government/publications/covid-19-test-validation-approved-products) would suggest we haven't.

For those getting excited about FDA approval, I suggest you follow Michael Mina on Twitter...

It appears the FDA is following the example of MHRA/UKHSA - bogging manufacturers down in unnecessary validation and testing processes, whilst favouring a few manufacturers. This has led to a shortage of LFTs in the US... which sounds mighty familiar.

"https://www.gov.uk/guidance/ce-marking

It should buy us time for getting UKCE though."

Not really relevant now, as the UKCA process for Covid tests has been superseded by the CTDA regulations: https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply

"ODX is dealing with a ‘notified body’ i.e. an entity that acts on behalf of the EMA as a sort of intermediary."

Notified bodies don't act on behalf of the EMA - they are independent third parties that are recognised by the relevant competent authority within a jurisdiction.

Nope - this RNS is potentially misleading in suggesting that the test has approval for self-use in the UK.

"...announces that the AffiDX® SARS-CoV-2 antigen lateral flow test has received a CE mark for use as a consumer self-test in the UK and EU."

There's some heavy criticism of the FDA approvals process from Michael Mina on Twitter. It appears that the FDA are taking a similar approach to the UKHSA - bogging manufacturers down in unnecessary validation and testing processes, whilst favouring a few manufacturers. This has led to a shortage of LFTs in the US... which sounds mighty familiar.

Hmmm... the Avacta RNS appears to be somewhat misleading. It suggests it has got UK self-use approval. The CTDA approvals list would suggest otherwise.

“ They'll pass tests when they're sure no-one will sue if they're at all inaccurate.”

Except that’s nonsense. The reason they’re able to keep using the less accurate tests is because they’ve waived liability. It’s also the reason they were able to roll out the vaccine so quickly - corporate and state liabilities were waived under the Coronavirus Act.

I would urge caution about the US market. As Michael Mina has been flagging recently, the FDA has introduced new requirements for LFTs which mean that many of the existing devices (including ours) may not be acceptable. Unfortunately, the FDA seems to be taking the same daft approach as the UK government on this...

"Makes you wonder why these were brought in as they have basically shut down the U.K. industry."

It was brought in to address the cowboy travel testing companies - except it didn't actually address the problems, as the tests being used weren't the problem.

"The CE mark should have been sufficient. It is an admission the CE mark failed."

The CE mark is sufficient for professional POC - which is what (with the exception of a small number of medical devices) ot was designed for. The CE mark system hasn't failed - UK governance has.

"They should have reviewed each test and withdrew the CE mark on any test that was not up to standard. Yet they managed to introduce a fee to review what they failed to do in the first instance approve a test properly and have done it at the expense of the whole industry."

As I indicated above, the CTDA was put in place to address the failings of the retail test market - but it doesn't do that. All it does is screw over manufacturers (unless they happen to be Tory Party donors or mates of ministers, in which case they get added to the exceptions list).

Don't know who writes the Wallet Investor ****e ...

"Abingdon Health Plc stock is a not so good long-term (1-year) investment"

but 1 year is not a 'long term' investment.

That’s the testing regime recommended by NHS England/UKHSA. The same regime applies to NHS providers.

Only staff working in higher risk units will be required to test more frequently.

I see M&G have taken a position in TTG, who are potential producers of the test for BRH/Paraytec.

“ Meanwhile Prof Shaw, Exeter, has his test on GB News for a 10 min discussion.”

That will have been seen by about 100 people max… 75 of whom work for GBeebies.

“ https://www.telegraph.co.uk/world-news/2021/12/13/south-africas-omicron-covid-outbreaks-may-already-running-steam “

The Torygraph. About as reliable a source for scientific fact and consensus as Nadine Dorries.

And Altona Diagnostics is a company HQed in Germany...

At least it's closer to the UK than China.

"I am sure I will be corrected if I am wrong but as I understand it, even though the DHSC contract may have lapsed HMG are still able to come back and rely on it. "

No. Once a contract is lapsed/expired/voided it is lapsed/expired/voided. The government can't come back and 'reactivate' the contract. Even if ODX agreed to a request to do so, it would be open to legal challenge.

The proper course of action would be for the government to issue a new Contract.

The government did announce they were planning to phase out free tests (except for those used for surveillance purposes). It's a stupid idea to proceed with that plan in the middle of a wave of a new variant...

I'm on leave this week. I'm going to be volunteering to support the vaccination roll-out locally (I probably won't be doing the jabbing, although I am trained to do it). I'd encourage anyone else with some time on their hands to think of doing the same.

Watch this from about 35 minutes in. A good primer on trying to deal with with Whitehall and the government…

https://www.youtube.com/watch?v=tG_a0P2qybE

(Nicked from BigJock on Twitter)