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https://www.bmj.com/about-bmj/editorial-staff/gareth-iacobucci

Out today in the BMJ, Gareth Lacobucci writes on the Innova and also highlights that MHRA are reviewing the Innova test.

Graeme Tunbridge, Medicines and Healthcare Products Regulatory Agency (MHRA) director of devices, said,

"The MHRA are reviewing all available information and are working closely with NHS Test and Trace to ensure that a full risk assessment is undertaken, as is our normal process, to understand any implications for products being used in the UK. Patient safety is our priority and we will publish safety information as and when necessary."

The DM doing what they do best, reporting on garbage.

"...the tests should be thrown in the bin or returned to its California-based manufacturer Innova."

Innova are garbage, shouldn't have been accepted on emergency use basis.

"The federal agency added that some of the performance claims Innova makes about its products were not corroborated by clinical studies."

This was quite damning. Innova was still advertising some of those claims.

Hurst. You've hit the nail on the head. The MHRA won't be renewing the Innova EUA and will result in Innova being dropped by the UK Gov. This implies that billions extra will be available for other test producers. Could have a significant impact on the Avacta share price.

It was a scathing report by the BBC. Innova contract is in serious trouble.

The FDA was being kind when the said the test should be thrown in the bin.

Don't talk rubbish. You are giving your personal opinion again.

Provide evidence.

"Read Minas tweets on the subject. I cant be rsed spoonfeeding you further"

You provide the evidence since you are so in love with Mina. Don't just respond with read the internet.

I'll tell you what Mina said about Innova:

"...we've found the rapid test used in the UK, the Innova test, is doing a great job w sensitivity & Specificity"

Unless you've been living under a rock since Thursday, the media picked up on how "great" Innova is. According to the FDA its fit for the garbage bin.

Again. I repeat - evidence please, not your personal opinion.

Evidence please, not ndn71 personal opinions. If you don't have any either change the subject or be quite.

"He would not be testing with LFDs today - Innova, Avacta or anyone else - and you support his argument!"

He co-authored a paper in March. He accepts 3 tests are suitable. At that time they state 3 tests meet the standard. It doesn't quite fit your statement.

Instead of making unsupported statements how about providing some evidence. I'll quote what Mina said about Innova and it's on twitter as you seem to use that as your main reference tool:

"...we've found the rapid test used in the UK, the Innova test, is doing a great job w sensitivity & Specificity"

I'd love to hear your opinion on how great Innova is?

Deeks on the other hand slated Innova then, and let's see what he says about Avacta:

"Good 1st results @avacta but make sure all studies are reported and peer reviewed so the evidence is clear to the world. @mologic are setting the standard..."

Oh hang on Deeks is positive about Avacta. What a surprise, the guy you've been taking a dump on from high is actually positive about a share that you are supposedly invested in. Hmmm, makes me think.

For the rest of your drivel pray do provide supporting evidence where Deeks says that LFTs need to be above 30. And please don't infer from false assumptions that Deeks only loves PCR and therefore he has a predefined... blah.

The paper compares WHO's priority target product profiles for COVID-19 diagnostics. By default it acknowledges the benefits of LFT. PCR is a reference point for LFTs for a reason, PCR are more accurate. He has never made the claim that PCR is infallible. Jon is a biostatistician not just a general statistician and is highly respected in his field.

Michael Mina doesn't understand the point that Jon Deeks makes. In fact Mina doesn't just advocate LFTs, he specifically goes out of his way to advocate the Innova test:

"...we've found the rapid test used in the UK, the Innova test, is doing a great job w sensitivity & Specificity"

Mina completely missed the point. Innova didn't undergo rigorous validation. They've been pulled apart by the FDA.

Jon Deeks has published a recent paper based on evidence not twitter statements. In it, he and many other respected scientists make the observation that LFTs are okay for testing symptomatic individuals and they go on to identify 3 out of more than 60 that meet the WHO standard. Deeks et al, go on to point out that data for asymptomatic LFTs isn't available. That's because the rubbish tests submitted to PD/PHE were not assessed properly. Avacta has been tested correctly in a clinical setting and Jon Deeks even points out Mologic as a good way of releasing data release i.e. should be done, so that they can be verified prior to going to market.

Mina emphasises the point of the benefits of tests like Innova. He states:

"Rapid tests are catching the infectious only!"

Making out that it's a good thing.

However, what he fails to mention is that the tests are not being analysed as intended. Those who are positive are sent to isolate. The Innova LFT negative tests have zero recommendations and there is no suggestion that these individuals are asymptomatic carriers. Furthermore Mina misses the point of detection at low viral load i.e. high ct. Innova were rubbish at high ct, yet Mina happily advocated them. The Avacta USP is the asymptomatic detection.

If anything Jon Deeks would support a test this sensitive. In a tweet after the initial data was released Deeks responds to a question on Avacta:

"Good 1st results @avacta but make sure all studies are reported and peer reviewed so the evidence is clear to the world. @mologic are setting the standard on how this should be done. And tests need to work at Ct>25. That’s a false dichotomy used for marketing poor tests."

Deeks paper also points out that data on asymptomatic tests has become available but after they had submitted. I wouldn't be surprised if they were referring to Avacta. Deeks seems positive but cautious. He is clearly not against LFTs if he states "Good 1st results..." about the Avavta test.

I invested in Avacta because like Deeks, Al Smith has been thorough and not a cowboy like Innova. I believe the approach taken by Alastair implies that Affidx when benchmarked against other LFTs will come out on top.

This is from his paper on lateral flow antigen tests for COVID-19:

"Evidence for testing in asymptomatic cohorts was limited. Test accuracy studies cannot adequately assess the ability of antigen tests to differentiate those who are infectious and require isolation from those who pose no risk, as there is no reference standard for infectiousness. A small number of molecular tests showed high accuracy and may be suitable alternatives to RT-PCR. However, further evaluations of the tests in settings as they are intended to be used are required to fully establish performance in practice.

Several important studies in asymptomatic individuals have been reported since the close of our search and will be incorporated at the next update of this review. Comparative studies of antigen tests in their intended use settings and according to test operator (including self-testing) are required."

He doesn't, and neither do the co-authors, dismiss LFTs out of hand. They go on to assess tests against WHO's priority target product profiles for COVID-19 diagnostics. Amongst >60 tests assessed, only three met the WHO criteria but only in symptomatic individuals. They go on to conclude that only a few LFT tests are suitable in symptomatic patients.

For asymptomatic individuals there was not enough data presented, but since writing this paper, they commented that other tests had come to light which they would be included in later reviews. The reason they reserved judgement of asymptomatic tests was because those making claims e.g. Innova had very different results in real world settings.

The Avacta data has only recently become available and isn't the target by Jon Deeks.

When he was highly sceptical of LFT asymptomatic testing was last December. He was right up be sceptical at that point in time because companies like Innova were making many claims. However since then better tests have been produced and the world leading test, Avacta, is able to pick up asymptomatic individuals.

Jon Deeks is not against tests as explained in this paper. He is, imo correctly, pointing out the poor testing and reviews in place by PD and PHE. This is exemplified by the stupidity of using frozen samples by PD.

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705.pub2/full

Also note Financial Times comment:

The UK medicines regulator is carrying out checks on rapid Covid-19 tests from the Innova, government’s main supplier, following a stinging rebuke of the product from the US Food and Drug Administration. FDA officials raised concerns on Thursday that Innova was distributing its lateral flow tests in the US without its approval.

https://www.ft.com/content/449c33a2-c3d5-4989-a7ae-b412e74b8781

I think it's wrong to be annoyed with Jon Deek's. He makes a valid point on newsnight - lack of validation in true clinical setting will result in poor tests that defeat the purpose. Until they are proved, it's wrong to throw money at tests. Lucky for Avacta, that the test they had carried out was in Spain in a hospital setting.

Secondly, I prefer European sales over UK, as I think the Avacta market risk is spread across multiple countries.

Jon Deek's doesn't make negative comments about LFTs as a whole as was made clear on newsnight and his comments in journals and on twitter. It's worth re-examining the narrative, he even goes as far as pointing out Mologic as being the right way to conduct trials. The very same Mologic who we've used to CE mark.

If Innova are dropped as the key test maker in the UK, then there is more pie available for more reliable tests (i.e. more potential sales for Avacta in the UK. Therefore, news for Avacta UK sales is coupled with negative news for Innova. For those who believe that we be better off with UK sales, then they should be also keen to see more negative news on Innova. In fact, silence from Innova is also a positive for Avacta.

Unless Innova can categorically defend their position and explain the fake data submitted to the FDA, then it will be very bad news for them. Graeme Tunbridge, the director of devices for the Medicines and Healthcare Products Regulatory Agency (MHRA) is looking into the issues raised by the FDA. The very same director will be renewing their EUA license to sell in the UK. DHSC won't be making any further sales to Innova if they don't get license renewed. It's a very tricky situation for Innova.

GLA

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