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02 July ODx put out an RNS specifically dealing with the FDA submission:-

"We are very pleased that the regulatory process to make our VISITECT(R) COVID-19 Antigen test available in the US professional use is progressing well."

BigBangs "It could be supplied for home use under an EUA."
The FDA EUA list, lists tests that have authorisation for professional or home use, there are 8 for home use. Given the massive market difference between professional and home, it is price significant if they were applying for home use, and would make the "professional use" line in the RNS above not only pointless, but misleading.

Unless they have changed their submission and not told us, the US FDA submission is for professional use only. It therefore could not be applied to bidens mandate, as that obviously needs a self-test device.

Nobody is suggesting it's novel, however its the first public confirmation that Mologic is using it on their test and suggests that ODX did not do the change in complete isolation of Mologic.

It's actually the best info we've had on either the original or the revised version.
We have a definite Mologic price, shelf life and confirmation that the FindX study was the biggest study that FindX have done. It's very likely IMO that the ODX visitect one is the same as the Mologic/GAD one, and if that is the case we even had a template for the instructions and what it looks like.

@Okehurst1 for the various CT valus check out the Findx data here:-
bit.ly/3nEeoi2

My previous post had the 2nd 'e' incorrectly in upper case which is why it doesn't go anywhere. I also note that the FindX data says 12 month shelf life, but they would be getting that from Mologic, which they have now improved.

In relation to FDA approval, she merely says it is awaiting approval and awaiting queries. In a different part of the presentation it is mentioned that there is a studies ongoing in the USA "which are towards our FDA submissions".

Also as a side note, the presentation confirms the nature of the take-over. GAD, which was a spin-off from Mologic, bought Mologic as part of the takeover process. GAD remains test agnostic, they are happy in the future to make non-mologic designed tests.

Nothing was mentioned regarding aspirations for the uk, other than they confirmed CE approval. The relevant slide also says MHRA approval at the same time as CE approval (dec 2020) but obviously that was for professional use.

good find okehurst1, skimmed thru the hr video.

So they are using pre-filled buffer solution, that have a foil top.

ODX made it sound like it was them that did the revision of the orginial mologic test, to make it easier to use. Given that this looks like exactly what ODX described, has there been independant tandem developement by ODX and Mologic to come up with the same result, or does it suggest that they've been working together on this ?

Regardless, It is very pertinent to note that athough Mologic has protested that it was simply PD testing that was at fault, they have also changed their test to a prefilled buffer tube. Covios is the Marketing name for this variation.

What I do know is that the underlying test strip/cassette (without the subsequent improvement) is the same as the one that was sent to sent to PD. When Emily Adams is showing the Find data (around 30mins in), below the table there is a short form link to the full FIND data sheet,(bit.ly/3nEEoi2) which brings you to the FIND data for the original Mologic test, dated April 21.

A great piece of info at 45 mins is that "as i mentioned, on the Covios test right now we are offering that at $2 a test ex works from our site here. Naturally we will be working with a number of distributions, we are working with them to keep their margins as low as possible, but i can't comment on the ultimate price they will offer them for"

18 month shelf life, extending to 24 months shortly.

Some of thoughts are that GAD listed about 20+ countries that they have relationship with. mologic being non-profit is going to be next to impossible to compete with in there. A scenario does exist if combined demand exceeds their 200M a year capacity (by end of year), in which case an ODX exact equivalent might come into play, however I think GAD has a plan to create local manufacturing.

Also, GAD are well advanced in a lot of other LFT diagnostics that affect African nations. Unrelated to ODX, GAD looks like they intend to do a lot of good work, fair play to them.

If it is as a result of getting a PCR test, it'll be lab based testing.

Had the invite myself recently, but as I recall it only proceeds if you end up with a +ve PCR, I never heard back from them after my -ve result.

I note, like the company, no timeline for actual orders.

Everything I typed was factually correct. Clearly a core here see unfavourable facts as deramping

Benny_hill, yet another of the pretend filterers .

It clearly was supposed to be the mologic one, and that didn't happen, and won't happen in it's original guise. ODX has hope that their modified one will get selected.

However, that does not explain why ODX is not producing another test. They have said for many months now that they are in discussions with several companies, all of which have tests that have passed the required standard, and who HMG introduced. Given the elongated time of discussion and conclusion there are a few possibilities.
1) ODX have not found any company that wants to offer them their IP to reproduce either at all, or only on terms that are so poor that it is not in ODX's interest to do so. Remember that in Mologic they were dealing with a company that had a strong social bent to their strategy. Other companies will not be so inclined.
2) ODX is gambling that their revised test will get selected. In that instance they of course get all the profit (except a small royalty to Mologic)
3) There isn't going to be a soverign test, an opinion expressed by the ex-chairman in mid-june. What about the $17M of kit supplied to ODX ? In comparison to the many billions given to Innova (nevermind the other billions of waster), it's chicken feed and easily justified as provisioning just in case.

I still think ODX will produce a test for uk gov.

"£374million purchase order."

There hasn't been any orders raised, never mind £374M of them. Its a contract that the CEO himself has confirmed has no minimum order and no cancellation penalty.

Stop ramping.

its far from over. That 200+ deaths figure from yesterday looks particularly bad, although I recall one earlier in the week that was 45, so there may be a bit of catch up there, however the trends are going the wrong way for sure.

Give it another week and see where the numbers are with the school effect kicking in.

the key for all the LFT devices is orders. To give you a far wider possibility, then self-test is needed, but self-test approval alone does not turn on the manufacturing.

The chat about the Mologic test failing PD just being because of PD using a weird approach, seems to be without foundation. Given that ODX has been in a position to produce an exact generic of the original mologic test for many months now, without a single order, strongly suggests that this was bigger than just a testing lab screw-up. Otherwise where are the orders, in a world we've been told is gagging for LFTs.

findx evaluation rated it's usability at 57 out of 100
https://www.finddx.org/wp-content/uploads/2021/06/Mologic_Ag-Public-Report_v1.2-20210615.pdf

as opposed the abbot score of 86 out of 100
https://www.finddx.org/wp-content/uploads/2021/06/Panbio_Ag-Public-Report_v2.1.pdf

So ODX making an easier to use version in my opinion isn't just making it even more appealing to interested parties, they decided to do it as it wasn't sellable in the current form and/or with it's PD history.

I see a document was posted in july by uk gov saying that that innova is no worse( or no better, depending on your opinion) at detecting the delta variant than the alpha variant).

"There is no difference in performance in its ability to detect the Delta variant in comparison to the Alpha variant."
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999867/in-vitro-and-clinical-post-market-surveillance-of-Biotime-SARS-CoV-2-Lateral-Flow-Antigen-Device-in-detecting-the-SARS-CoV-2-Delta-variant-B.1.617.2.pdf

Is there any data out there on the performance of the Mologic/visitect test on the delta variant.

the most interesting part of that twitter thread is the bit where someone asked:-
"HI, can you confirm you are still manufacturing at capacity"

You gotta love an optimist.

"Somehow nice to have a morning without all the inane, pathetic whingeing!"

Yes but I see you're back now !

if you are at a high risk of death, then many things might look a decent bet :)

Have to wait for it to get passed
It needs to get selected in the uk
then odx needs to start making 2M jigsaw pieces a week.

My understanding is that in the UK/USA it is mostly used in animals.

https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
Says it is licensed in the US for worms, lice and skin conditions.

Recent study is under investigation, as some are suggesting the data was faked.
https://www.theguardian.com/science/2021/jul/16/huge-study-supporting-ivermectin-as-covid-treatment-withdrawn-over-ethical-concerns

https://twitter.com/abingdon_health/status/1434822357902823424?s=11

Link to the ABDX tweet that in turn links to the study.

I see abdx has tweeted something that dials into this thread. Lancet article showed that out of 1482 people hospitalised in the UK that that were more than 21 days after vaccination, 400 of them (27%) died. Data came from the Zoe study.

Of course you need to dial into that age profile, underlying conditions, whether it was 1 or 2 doses etc, but the headline is worrying in that more than 1/4 of people hospitalised, died.