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Thanks DG. I'd forgotten about that
vox markets have updated their assessment
https://www.**********.co.uk/articles/new-article-99c52f4/
What's all this about elephants not getting all their feet off the ground at the same time. You guys never seen Dumbo?
Avacta has not managed to get the AffiDX trademark registered in the US, and that's even after an appeal. Even though there is no trademark "AffiDX" on the register, it seems that the text is too close to to other trademarks that have been registered to be accepted.
The current situation regarding registration can be found at..
https://tsdr.uspto.gov/#caseNumber=79304130&caseType=SERIAL_NO&searchType=documentSearch
where you also clock to read the suspension letter. Good luck at trying to make sense of it!
Avacta could try for other trade mark names e.g. AvactaDX ...RX ..TX, or take on a US partner, but the AffiDX trademark doesn't look like it will fly in the US.
It looks like Avacta will not be allowed to register this mark in the US
https://tsdr.uspto.gov/documentviewer?caseId=sn79304130&docId=SUL20210831125804#docIndex=0&page=1
The problem is getting enough fresh positive samples for the analysis. Because most tests are done at home and there is a day or more delay between test and PCR validation, we need another arm of test and trace that knocks on the door of anyone testing positive and asks to take a larger volume of sample fluid from the infected person to transport to the testing lab.
Suitable targeting of "hotspots" would reduce the logistical problems.
Now with the prevalence in the population rising, would be the ideal time to instigate such a process.
Has there been any news on this? The last info (from the RNS of 22nd April ) says
"The Diagnostics division has established a Quality Management System and the first external audit by the Group's Notified Body (BSI Group) was passed in December successfully. The second and final audit was scheduled in March 2021, but due to a COVID-19 case at Avacta's Wetherby site, the second audit has been split into two with the final site visit now occurring in early April. The Group is awaiting confirmation of a positive outcome to this second audit. This certification sets the organisational and operational framework for all current and future diagnostic product developments and it is an essential accreditation that underpins future commercial success."
From the excert above, I presume that the Wetherby site still needed to be audited.
All I've been able to find out is that Avacta is not registered as having a 13485 accreditation on the BSI website, and that commercial organisations that offer to help companies through the accreditation process quote 60-90 days for the stage 2 audit stage.
Anybody heard anything?
doze. You seem to be missing the point entirely.
I was proposing 2 tests. The 1st gives a result that says whether you have enough of the virus to isolate immediately. The 2nd says you seem to have a small amount of the virus, and may be on the point of becoming a spreader.
I think you should now consider just how quickly the virus spreads in the body. BMJopen Volume 10 Issue 8 article reference e039856 would be a good place to start. Just look at figure 5. You can go from undetectable to full-blown in under 24 hours. Can you see the advantage of giving a more sensitive LFT test to those who have occupations which involve coming into contact with prople who may be infected, or those in any hot-spots that emerge.
But there are caveats with the second test. We are near the limit of detection which means that the chance of producing a false positive increases. (We can retest these to give us a bit more confidence.) And we cannot differentiate between those who are in early stages of an infection, and those where the infection has peaked and is now in decline, and may even be fit to go back to work. Hence the need to look at the testing history.
There I got through that without mentioning the dreaded PCR word once.
doze
I said "equivalent to". Many of the specifications for LFT tests refer to an equivalent PCR cycle threshold. You can take the the readout sensitivitities to mean:
At a viral load that would show up if a PCR test was run within 25 amplification cycles in the case, and within 32-35 amplification cycles in the second case. I'm sorry if I wasn't clear.
doze
I know what a PCR is. I said "equivalent to" by which I meant in the same level of viral load that would amplify up to a positive result after 25 Ct cycles or less if a PCR test was run in the first case, and after 32-35 Ct cycles in the second more sensitive case. Forgive me if I wasn't clear.
Not the first time this has come up.
Personally I'd like a 100% specificity strip with 2 readouts- one equivalent to a PCR Cycle threshold of 25, and the other with a PCR cycle threshold of 32-35. The first will indicate if you sre currently infectious, the second if you are have either just contracted the infection, or have have been infected recently and your peak infectiousness has past. To differentiate between the two alternatives for the higher Ct , you could look at previous test results for the same subject. The test would rely on testing every 1 or 2 days so that you have a time sequence to differentiate between the two 32-35 Ct possiblities, but would be appropriate for patient facing staff potentially exposed to the virus.
I can see John Bell's point. Burgers and Bacon contain protein. The Affimer in the LFT binds to protein, in the 3-D lock and key way that enzymes etc work. We have been told that the Affimer is highly specific to Covid19, in that it does not bind to any other Corona Virus. What we have not been told is whether there are protein chains from sources outside the Corona Virus domain that the affimer could bind to. In fact you would be a fool to expect this, because there must be a near infinite number of possible organisms that you would have to screen.
The only way we are going to know if the specificty is affected is when the phase 3 and 4 clinical validation studies are published.
So I can see why John Bell may be concerned. I would hope that by now Avacta have taken lots of samples from lots of peoples' mouths and checked the affimer's specificity. Their recent silence isn't helping anybody.
I think there may be a misunderstanding of what Condor will validate. It will not just be the chemistry of the test, which we know works. It is the "product" made up of the several components within the LFT package, any other ancillary parts that are shipped with it (to spit in for example), all the manufacturing processes that produce the reagents and assemble the LFT, and all the processes to ensure that biological samples that are taken during the test are handled and destroyed safely.
There is no point in validating any product unless the validation results can be reproduced.
Until batches of the Avacta test are manufactured and handed over, Condor will not be able to start their assessment. (although I hope that they are giving AVCT, BBI and Abingdon support and guidance in the meantime).
The key question which AS should answer is "When will a production line be built , tested and producing our LFTs?"
It does seem that we have had a good candidate for an awfully long time.