The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
"surely the takeaway for ODX is that “desktop reviews” of company’s own data will be satisfactory.
So Mologic being rejected by PD becomes irrelevant.
Govt can ramp up UK production with either Mologics test, or Avacta’s, or both"
No. People are conflating two processes.
The consultation was in relation to proposals to introduce new requirements for professional use tests that were/are being sold to the public by companies (i.e. not DHSC/NHS/PHE/ONS tests). It was about adding a further step to get marketing authorisation for professional use.
The PHE Porton Down process is a separate process, aimed primarily at two things: providing HMG/DHSC with air cover for their EUAs and for identifying tests that may be suitable for non-professional use (as SE/UKCA marking only applies to professional use).
The challenges to the PHE PD process are separate from this consultation. I don't believe that this consultation will add anything to those challenges.
I personally think that the challenges to the PHE PD process will bear fruit for some developers/manufacturers (particularly Mologic) but may not have the desired results for other (e.g. Those Who Must Remain Nameless).
I'll go back to what I've been saying from the beginning. I'm in ODX for the long term and I'm talking years - not months. This is a company that has carefully positioned itself to be a cornerstone of UK and European LFT manufacturing and this will pay dividends in the medium to long term.
I totally agree the government want to pass the cost onto the public or to businesses in the private sector that require them. There won’t be free LFT testing indefinitely but when this will stop isn’t clear yet. What is clear is that there is a framework being drawn up for testing that is designed to create a minimum standard that tests have to conform to. There will then be a requirement for individuals to test at certain times whether that is for travel, entry, contacts with infected people etc. It’s at this point a lot of people are expecting the quality of tests to really shine through and the best to become the one that sells the most. That’s absolute rubbish and price will be the deciding factor. Businesses will want the best bang for their buck and the public are heavily price dependent. If all available to buy tests conform to the government standard then why buy the most expensive? Some people will, but the majority won’t. There will be a huge amount of testing over the next few years and price point will play a major role in that. Let’s hope the government plans keep the riff raff cheap rubbish out of the market, if they do then ODX, AVCT, Mologic, Suresrcreen will all do extremely well as the market will be insane.
"Who do you think the 'consumers' are, if they're not Joe Public? i.e. Home use Joe Public"
Err... no. If you actually read the consultation (as I did before responding to it on behalf of my organisation) this isn't about 'home use' - it's about ensuring that when people purchase a test from a company that what they are getting is reliable.
At the time the consultation was undertaken, the tests in scope were 'sample at home and return for analysis', i.e. it fell within the scope of professional use. It was not in relation to LFTs for home use. In part it was as a response to criticism of their proposals for travel-related testing (as a number of companies were found to have been selling tests that were not fit for purpose).
As tecbadger says, this is also a prelude to the government shifting the cost of wider testing from DHSC (via the NHS and PHE).
Scardey the information to consumers about what tests they purchase is actually a repackaged requirement from the new IVD regulation set to kick in May 2022 as part of the (currently nonexistent) EUDAMED database.
I read this update as tests being sold privately rather than government purchased to be honest I qouldnt be surprised of the strategy is to run down the innova stockpile from the public purse and then transfer the cost of testing to the individual once exhausted (who can then purchase whichever test they wish)
@Regulator
"We also want to make it easier for consumers and employers to compare the performance of COVID-19 tests to help them make informed decisions on the tests they purchase."
Who do you think the 'consumers' are, if they're not Joe Public? i.e. Home use Joe Public
Actually you could say that we have never had to pass PD for home use.
What they were allegedly stodging up was the validation of perfectly good tests (hurdle now removed for the purposes of the new legislation) . Home use was always (correct me if I'm wrong) dealt with by way of self administering studies then CE Marking then MHRA approval and will no doubt continue to be done this way (or by EUA)
In the meantime imo AS of Avacta and others continue to liase with the government and PD in respect of their procedures being fit for purpose.
"Consultation Outcome – We don’t need to pass PD for Home-Use!"
That's not what the consultation says.
The consultation was on the validation of tests being offered by private providers (i.e. do we need to ensure people aren't being ripped off by unscrupulous companies using dodgy tests). It was nothing to do with 'home testing' in the sense of the public using LFTs.
*including the governments full response.
Below is the full outcome of the consultation for private coronavirus testing validation, including the governments.
https://www.gov.uk/government/consultations/private-coronavirus-covid-19-testing-validation/outcome/private-coronavirus-covid-19-testing-validation-government-response
Of note:
“…at this stage, we have taken the decision not to make the laboratory element of validation a mandatory requirement. Initially, we have decided to implement mandatory validation of COVID-19 tests via a desktop review delivered by DHSC.”
And importantly:
“2.4 The government’s proposal:
We are proposing an approval regime that would require persons seeking to bring a test to market in the UK to register via an online portal. CE marking will be a prerequisite for applying for validation. They would then submit data for a thorough desk-based assessment including evidence of laboratory validation already conducted.”
So, we just have to submit data from our own validation and DHSC will decide if it’s good enough.
Haven't read it all yet, but I think I'm right in what I'm saying.