Member Info for marik

Combined with the on-label use of tests being more clearly defined by the MHRA, any suggestions of exempting tests is purely for on-label use ONLY. For Innova it means detecting only positive people under an EUA clause.

The UK market has blown wide open! Which is great news for those wanting UK sales.

TallPaulNY, it certainly puts the MHRA on the back foot and explains the two month extension.

This article from the BMJ(1) gives an indication from an expert in the field who has found the 2 months questionable. Sheila Bird says that: Sheila Bird, "The MHRA may need some time to tackle fully the plethora of study design, regulatory, and transparency problems raised by the FDA. Needing some time may explain why the MHRA accorded the Department of Health and Social Care an interim two month extension and has yet to make public the basis for its interim judgement."

This coincides with feedback received from others in the diagnostics industry with insight of the issues raised of Innova by the FDA. It will i) "allow an ongoing supply" whilst buying time to justifiably look through the data and ii) it helps the government save blushes whilst the current stock is depleted. The article emphasises that the Innova test is only for identifying positive cases. Furthermore the MHRA has been requested for redress of the "transparency failures, including that it has not provided details on how the recent review was carried out or its findings".

https://www.bmj.com/content/373/bmj.n1582.full

They've been clearing for a while but not in anticipation for Monday.

Scardey, good luck with the reading over the weekend, as there is a lot to go through about the *private* COVID-19 tests and the traffic light systems.

I'm also gearing up for an England win this evening and quite a lot of reading.

GLA have a great weekend.

I'm not the one asking for explanations and have no need to get back to anyone. However, let me fix my previous statement:

There's no point in forcing a square peg in a pin hole. They don't have exemption beyond the 2 months.

The market has reacted to account for the recent changes, its positive news.

Hope you enjoy the football tonight and the weekend. Alistair will explain the positive nature of the news next week. I've topped up.

GLA

There's no point in forcing a square peg in a pin hole. They don't have extension.

Innova have extension for 2 months and that's it. There is nothing further, not in colour or black and white.

There is ZERO chance for exemption. They've been given a two month extension and that's it.

A takeover is much more likely to happen now that we know Innova will be cleared out over the next two months.

There is ZERO chance of Innova gaining back door exemption.

I'll be adding shortly, assuming there is no RNS at 7am.

Well done long term holders. The penny is about to drop.

GLA

With this Government, I wouldn't have put it past them to have multisampling of stool + saliva as the optimal choice.

LOL. They've moved a few things, but I think the key point is the Innova will not measure up whatever the movement. That explains the 2 months extension for them and they will be dropped there after. For me this is a very positive move. The LoD, PPV and 1-NPV work out well for Avacta at low prevalence. Excellent news for Avacta.

To top it off Jon Deeks deems this "well thought through and justified (there's lots of maths at the back) to explicitly stating the evidence and performance levels we need."

The game is afoot!

Great news. See Jon Deeks comments that approve the new changes. Avacta will likely be to of list for meeting self- testing. No doubt this underlines that Innova are about to be dropped soon.

https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-in-vitro-diagnostic-ivd-self-tests-for-the-detection-of-sars-cov-2-in-people-without-symptoms

https://mobile.twitter.com/deeksj/status/1405574419523776525

It's the only logical way to save face. The Government has to justify why they've spent so much on Innova and by immediately scrapping their test would signal that they're also incompetent. This was one of the ways to save face for themselves and not kick up legal action against them from Innova. The MHRA should be asked to provide the review report that they've apparently carried out.

EU should read EUA in title

I have to agree with Jon Deeks response:

"It seems a little bizarre that the extension is only 2 months if everything is satisfactory."

https://mobile.twitter.com/deeksj/status/1405508278633873412

Sales are a foregone conclusion, it's not a matter of if, but when.

"Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX® test will now play a significant part in this process."

By using the term "will now play", Alastair points directly at UK sales.

CE marking news has only recently been announced for UK (8 working days) and EU (4 working days). Being impatient with "no sales" comments only underlines a lack of experience, that of course assuming that you're invested in Avacta.

The Innova test as we've now come to realise from FDA comments was not fit for any purpose. It's a useless test that attempted to find asymptomatic people. Innova Ct between 25-30 has a sensitivity of 14%. Innova have damaged the image of other lfts in the process.

The key message to the public is: 2nd and 3rd generation tests are far superior.

It's not all old stuff. This was published on the 15th June. It highlights the issue for the Innova test in the Liverpool study. The common held belief is that it was a test for symptomatic people. What Sheila's article tells us is that this is false, i.e. the Liverpool study was to test asymptomatic people. What's upset the MHRC is that they did not provide emergency use of the Innova test for asymptomatic testing. i.e. Innova is not fit for purpose.

However, we still have comments on this bulletin board that falsley assume that the Innova test was fit for purpose and agree with Michael Mina's narrative.