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Mr A - Agreed.
I return to targeting the spike over N. The prevalence in the AN area is much higher, therefore collected more efficiently. The fact our swab requires 1cm insertion, vs 2-3cm leaves less margin for error in self admin use.
Other than in being named as the test of choice when pharmacies run out of the Innova tests??
We is happy then - thank you for the alcon info - appreciated
And relax. .
Sure is MrA. It seems that the FIND study states that 95% samples were from symptomatic patients.
https://www.finddx.org/wp-content/uploads/2021/06/Acon_Flowflex_Ag-Public-Report_v1_20200609.pdf
And it appears to be the choice of Scottish pharmacies
https://www.chemistanddruggist.co.uk/news/pharmacy-collect-supply-innova-test-kits-first-when-new-brand-arrives?cid=ENL-DAILY-LN-STORY2-TEXT-2021-07-28
Acon Flowflex requires a swab inserted 2-3cm. Not sure this is classed as non-invasive? Probably is.
Also worth reading this: https://www.medrxiv.org/content/10.1101/2021.05.11.21257016v1.full.pdf
Check Table 1, number 2 on the list. Note - the study discuss freeze/thaw samples. Given what we know, this could undermine its results.
@icecool - I'd be very surprised if the dataset had to be limited to the Delta Variant (as there won't have been enough time to collect it). But equally I'd be amazed if there wasn't a subsequent requirement to show efficacy against all the Variants of concern including Delta.
Ophidian
My misteak -Surescreen is 20million tests. Published price is £6.
Cannot see if detects delta.
Acon seem biggest threat -Anterior nasal, self test.
Quick question regarding this new approval process is this based on delta variant or original covid? My concern is you could have companies that provide a data set based on a redundant variant, although I’m hoping the data is broken down for each variant but have my doubts!!
“The Delta variant study adds to the Avacta numbers and would almost certainly provide the more than 100 positive cases.”
That may well be the case but an RNS Monday saying AVCT is taking part in an enhanced study results of which should be available in the not to distant future....or words to that effect.
Well that should really do the trick for the SP!
They gotta announce near term cash flow!
Trek
“Validated Against Delta Variant – Routine monitoring of all emerging variants to ensure continued diagnostic accuracy”
Imo Data set numbers are not a problem routine monitoring will have strict procedures in place that can be added to any future data sets.
Gla
im guessing avacta were pleased with their sensitivity result but were immediately concious that the error bars (the range of possible sensitivity) were large. presumably work would begin immediately on increasing the n number in order to reduce the error bar - 98% sensitivity with small error bar may be better than 99% with a large one. There again that would need a sense of urgency.
on a related note surescreen have won a contract for £20M. I think this is about 2-3 weeks stock but why this amount is unclear. It is politically astute and covers a certain Lords rs - boris visited the factory but maybe it is all they can make or is limited to allow multiple uk companies in. just a thought.
@bebx4 yes agreed.
The Delta variant study adds to the Avacta numbers and would almost certainly provide the more than 100 positive cases.
@A1 Invest - you state that:
"There are minimum sample sizes for the clinical data and Avacta fall short of this currently. The Spainish clinical trials used 98 positive cases whereas the essential requirement is 100 ."
Which is true, though I would add that since the Spanish trial, the device has been validated against the Delta variant using real patient samples.
Presumably - to get a statistically meaningful result - this would have involved more than one or two patient samples.
Presumably also, this data can be incorporated into the wider data set which would take us over the threshold here - I imagine they would have kept the type of PCR comparison constant for this reason, though this is speculation on my part.
I think this "New" process is still a stop gap measure as slowly but surely COVID medical devices migrate towards the approval processes for all other medicinal products. The Emergency systems originally in place were probably the right way to go - it's just unfortunate that the science didn't come up tot he usual Porton Down standards. Understanding of course that the PHE group at PD are distinct and separate from the word renown Bio - weapons side.
Ophidian
Ide be interested to know what the driving factor was for amending the approval process.
Reckon the GOV's legal team had a good read through Mologic's case and said we've not got a leg to stand on here?
Mr A What's your point? Where's the harm in a recap of useful information? We have been through a lot of disappointment here recently, but I think that the announcement of a new testing regime is a sign that we can still profit from UK testing
yes, the following commercial 'Risk' from the annual report is now vastly reduced;
In order to participate in tender contracts offered by the
UK Government, the AffiDX® SARS-CoV-2 Antigen Lateral
Flow Test has to pass an evaluation process at the UK
Government’s Porton Down facility. The first stage of the
evaluation process does not use the lateral flow test in
the manner that it was designed for and there is therefore
uncertainty as to whether the test can pass the Porton Down
evaluation process which could delay the ability to tender
for government contracts. The Group is progressing the
clinical validation and CE marking of the product so that sales
channels (other than the UK Government) can be exploited
regardless of any delays in obtaining UK Government
approval or tenders.
Also it will become unlawful to sell tests in the UK unless they are on the UK approved list. This should clean up the UK market and also for those successful enhance world wide selling prospects.
It's going to be interesting to see how many Porton Down approved tests fail the new criteria.
Thought I would post this overview as I feel this change is massively positive for Avacta.
Previously Avacta was unable to be validated as a UK approved test because the testing methodology used by Porton Down used frozen samples and AffiDX did not work well with frozen samples.
The new approvals process has removed this requirement and replaced it with a review of clinical test data provided by the company.
https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply
* This puts Avacta back in the running to be on the UK Approved List.
Also the new process has no exemptions so all existing tests will have to go through the process.
* This evens the playing field with existing foreign supplied tests.
There are minimum sample sizes for the clinical data and Avacta fall short of this currently. The Spainish clinical trials used 98 positive cases whereas the essential requirement is 100 .
* Avacta have said they are working on more clinical test data but we don't know how this is going.
So a change from:
Being unable to participate in the UK market with 30 odd tests already approved
To:
Being able to take part in the UK market and existing approved tests needing to restart the approvals process.