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Porton Down decided based on their own evaluation that frozen samples are OK. They have been indecisive on this. There's published research from Thermo Fisher from 2017-18 to say that frozen samples degrade over time, especially if they are frozen and refrozen more than twice.
What a **** up.
Some tests have been approved. ODX will make one of them. £374 million. Stay focused.

Coming back now. Looks like Mologic are confident that they will get US approval. Porton Down have messed up the evaluation process using freeze dried blood samples. The Innova test seems to have been approved despite poor evaluation purely due to their capacity to supply at scale. ODX can supply at scale now and they will supply whichever test is approved. Keep your eyes on the prize guys.

Schalfplanet, what planet are you on? The FDA have recalled the Innova test. It has been publicly shared directly with the public and covered by every broadsheet newspaper in the UK so far, plus Newsnight. The FT says the MHRA are reviewing it now.
ODX are progressing through the US fast track NiH programme, the UK Porton Down process and more recently the EU regulatory process.
In the meantime Johnson will be announcing an extension of lockdown tonight. Twice as many sells as buys? Unlikely. Mms selling spare stock and buying it themselves. Otherwise we would be looking at a drop of much more than 3.5p with the buy to sell ratio today.

Has everyone seen Twitter? Joly Maughan is all over this. He has rightly highlighted the bit about Innova appearing to have stolen someone else's trial data, claiming it as their own. Joly Maughan is also claiming that Innova got the contract because a fixer with contacts sorted it out for the distributors. He's sharing an extract from an unverified source to that effect. The DHSC have said they have evaluated Innova, at about 5pm, and the MHRA have said, shortly after that they are reviewing the health and safety data. My guess is Innova will have been thrown to the dogs by Wednesday? Gentlemen's bet anyone?
Bloody heckers like! You couldn't make it up hey?

Big Bangs, I reckon all lths are with you on that sort of expectation/hope. Second that emotion! ODX is well placed to step up into the breach.

Aberdeenman, yep. I am hoping CK is having a very active dialogue indeed, with the DHSC right now!

So they are trying to change the subject with casual conversation. I love a casual conversation. But not with them.
And in the meantime the US FDA have ordered a withdrawal of Innova tests! Which the UK government have an order for an outstanding £2 billion. And the matter is hitting the papers.
And ODX is the preferred manufacturer for the NHS lft. Innova were definitely affecting sentiment since they announced they were opening a factory in Wales. I hope the government gets a grip on this and moves to block that proposal and quickly replace the £2 billion Innova contract. If Innova have shown themselves not fit and proper persons to run a company the UK should be able to get out of that contract scott free. If they persist with it they will undermine the whole lft premise and UK disease surveillance will be scuppered.

I wondered if it would be in the proper papers yet. Already in the specialist medical mags I see from Twitter. Good to see.
As Tecbadger suggests I wonder if we can influence coverage? The Guardian have missed out the fact that the FDA are accusing them of copying a competitor's trial data. And they have let Deeks say our regulators don't scrutinise tests! What a nonsense. They scrutinise through at least 3 key stages once they have been CE marked and independently assessed. Mologic have been through at least 4 separate assessments.
1. Ulster University. 2. Liverpool School of Tropical Medicine 3. FIND 4. The US NiH is in process.
5. Porton Down phase 1 and 2.
But clearly Innova have missed some of that scrutiny.

Bang Bang, that might be the best outcome for all concerned- well except Innova! If the government can shift the responsibility for a withdrawal of the contract to Innova's commercial impropriety and quickly move to a resolution with an alternative provider, it might not have as much of an impact on public confidence for testing in general.
The G7 statement today on vaccines and surveillance (tests of all kinds) for the world should improve confidence.
Anyway, good to see what everyone thinks. I am over and out for the day. Taking my car in for a service!
GLA.

Shelley, what on earth are you on about? This is nothing to do with CK. He just needs to keep that dialogue going with the DHSC. Make sure they know he is ready and willing. And we already know from the last RNS that is already happening. A big thing has happened. Get with the bloody program mate. No-one gives a damn about your CEO bashing obsession.

Aberdeen man, totally! The most shocking part of the FDA decision as published is that they allege that Innova have taken data from a competitor's trials and claimed it as their own. It's mind-blowing.

Yeah true. Deeks could be a useful advocate. He will stick to his most recent position- Innova crap, other tests may be very good. He changed his tune, not after threatened legal action ( after a pretend apology he continued berating lfts). He changed his tune after he had been shamed by Sir John Bell and the whole of the JCVI writing to the Times to question his credentials. And he backs off from Dr Michael Mina.

No Regulator. The degradation issue is established. Thermo Fisher identified the problem with degradation of blood samples from the process of freezing and unfreezing several years ago. They recommended that the process should not be undertaken more than twice. Professor Tara Moore from Ulster University also raised the matter in relation to the discrepancy between Ulster's evaluation and the PHE assessment of the ABC19 test. And Public Health England also changed their mind on whether to use fresh or frozen blood samples in recent months. They also acknowledged mistakes in their treatment of blood samples in the EDSAB report published in November 2020. I shared the Thermo Fishcher report and the EDSAB report when it was published.
Yes. It does raise big questions about PHE's role obviously. They have questions to answer. The host of specialist academics and reputable bodies like FIND who have evaluated Mologic's test do not have questions to answer. Of course it will affect public confidence. The crucial matter for us, is how will the matter be resolved. I think it will work for us. £2 billion allocated really needs to be withdrawn and reallocated. We don't know who will get the additional resource to breach the gap but ODX are in an excellent position as part of the UKRTC.

Bang Bang, I don't reckon Deeks is really the point now is he? The story is bigger than him. But he has already said his issue was with Innova. Ever since Dr Michael Mina has been kicking his arse. He might be useful in getting this on the agenda. He will use it to try to restore his reputation. But he's an 'unreliable witness' as they say, from our point of view.

Regulator, no-one seriously knows exactly how it will pan out. It's more a question of us as shareholders being privy to some dynamite news that will hit the papers. I think there are some serious questions about Innova's approval. Their first evaluation results were about 84% sensitivity. And then suddenly they achieved the MHRA bar, which was 98%. If they have sent in dodgy data to the FDA they will have totally lost credibility. But yeah. It raises the question how did they get past our independent evaluation which require firms to submit at least 1000 samples for double checking.
I have an instinct it could be back to the pickle that PHE have had about degradation of frozen blood samples from repeated unfreezing and freezing.
ODX have done multiple assessments which have been independently evaluated by FIND, the US NiH programme, Ulster University and Liverpool School of Tropical Medicine. They are in a super strong position. PHE are on the back foot however.

1Noise, absolutely. It's a very shocking revelation. And it explains a lot about what we have had to put up with as shareholders. I am expecting a front pager from at least one of the quality papers at the weekend. But it's the kind of thing that all the tabloids will get onto as well. Followed inevitably by the TV news outlets. I am hoping the government get on top of it with 'the UK diagnostics industry ' story and don't become completely overwhelmed.

Hasn't made the papers yet but it will over the weekend. John Deeks is already tweeting about it. He might actually do us a favour for a change if it helps get the story out. He has been thoroughly shamed by the great and the good, including Sir John Bell, writing to the Times to question his credentials. Deeks has been changing his tune recently too. Saying 'some lateral flow tests ' are very good. Just not Innova.
This is like getting a sneak preview into the news next week and over the weekend. We're all able to be a bit 'Captain Foresight.' A useful tool. The MHRA are going to be under massive pressure to shelve Innova. ODX have suffered from the UK's commitment to them. I think it has taken the pressure off the MHRA having a test already available for mass use, from bothering to get other evaluations done- they have focused on vaccines alone.
A big question mark raised about the competency of Public Health England now. The early reports are already recognising the FDA charge that Innova have made up their results! Dynamite.
The government are going to have to move fast now to try to look like they have a plan. And get that order done for ODX. If they recall any outstanding Innova contracts that's another £2 billion contract for antigen lfts that needs to be agreed.

And we're off! Good luck all.

1. Selection of the UK NHS lateral flow antigen test and contract for up to £374 million. Contract already signed. Test to be confirmed.
2. Approvals for the Visitect antigen lft from the UK, EU and the US. All in process already.
3. Sales for the Elisa antigen PCR- distribution partner is Screen4, an approved 'fit to fly' provider for the UK travel industry.
4. ABC19 antibody test lft waiting for MHRA approval.
All tests are CE marked and available for professional use with high sensitivity and specificity in accordance with international standards.
Long term pipeline also includes HCV and CD4 tests for hepatitis and food intolerance. Already approved by the WHO and China respectively.
GLA.

All party support to get the aviation sector back up and running. They all know that the EU already have the covid certification scheme agreed and ready for July 1st.