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"i do dabble. Also like to try and keep up on the progress of the precision medicine work there out of personal interest. Not mentioned much though."
I'm an Avacta shareholder as well, but I find that board (like a few others on LSE, e.g. RMS) greatly OTT and in great part adrift from reality.
i do dabble. Also like to try and keep up on the progress of the precision medicine work there out of personal interest. Not mentioned much though.
I see you've stuck your toe into the Avacta board, tecbadger... I don't whether you're brave or foolish!
Amen to that tecbadger.
sleepydave most of the time i comment there my questions are responded to with abuse and completely drowned out by positive reinforcement bias of the posters. I wish AVCT well as I do with any British biotech companies. Hopefully one positive to come out of the pandemic will be a rejuvenated diagnostics sector in this country.
Maybe it will all work out with the AffiDX test and both companies will benefit i maintain though its a highly unusual path thats been taken.
Hi tecbadger.
You will know more than I do about ISO13485 compliance.
AVCT told us in November that they had made good progress in putting in an ISO13485 accredited system.
On 24TH Feb we were told that they had already passed the first audit by their notified body.
The final audit was due in March and results are awaited.
In the meantime however if for any reason there is a delay in the final audit procedure Mologic seem happy enough with the Quality Management system in place to have offered CE accreditation under their own procedures if necessary.
Apologies to all ODX'ers for this.
You'd be welcome on the AVCT board I'm sure if you wanted to debate this further tecbadger
Very well done! you have confirmed that the relationship is there for mologic to assist with CE marking but you have not answered my question as to whether that means that they are doing further development studies with a product thats already in clinical trials.
Bonus point if you can tell me what happens if new development work identifies the need to change the design.
selective reading as ever goldtrig. Does that mean mologic are doing the development studies? After the product has gone to trials? How have AVCT documented their Design History File to comply with CE marking without having the QMS in place during the development timeline?
Sleepydave the reason i commented before is that the lack of an ISO13485 compliant quality management system is a huge problem as it is not only a requirement to CE mark but it also provides the basis and structure required behind the development process. The feasibility (Research) results from AVCT work look very promising but ive seen so many products in this space that worked extremely well when set up by the design experts within the discrete conditions of the R&D labs but then performed terrible in other hands either due to usability or environment.
The point is we just don't know anything about the development process of AVCT. It was developed not under a QMS so, to my mind, vital studies could have been missed. The one that springs to my mind the most is interfering substances where you test the diagnostic performance of the product in the presence of inhibitory compounds likely in the target samples to ensure it isn't affected.
I am categorically not saying that i KNOW AVCT dont have a conforming product, however, i am saying that if it makes it to market its process has been highly unusual as the timeline appears to indicate it started clinical trials before mologic were contracted to provide CE marking under their ISO13485 QMS.
Will do Regulator.
See you...….
"Regulator
Your last reply
1. Deliberately misinterprets my last post
2. ignores our previous discussion on PHE validation.
Nice diversionary tactics"
Trot on Sleepy...
Regulator
Your last reply
1. Deliberately misinterprets my last post
2. ignores our previous discussion on PHE validation.
Nice diversionary tactics
"Re the CE Mark.
We may have it. AVCT already have better results than Mologic used to CE mark their own test. The previous RNS on the subject covers it without the need for another. Its a non issue. When we come to sell we will have it!"
So you think that a CE/UKCA mark is a "non-issue".... riiiiiiiiiiiiiiiight.
"Re PHE validation (assuming AVCT decide to go with the government) this imo will be already in hand. You will recall we discussed this previously."
If Avacta wants its test to be considered as a sovereign test, then it will have to go through the PHE validation process. There is no other route.
And, if the current consultation proposals go forward, it'll need to be subject to independent validation to be sold in the UK, even if not put forward as a potential sovereign test. Avacta might have a test ready by the time the new regulations are in place...
Re the CE Mark.
We may have it. AVCT already have better results than Mologic used to CE mark their own test. The previous RNS on the subject covers it without the need for another. Its a non issue. When we come to sell we will have it!
Re PHE validation (assuming AVCT decide to go with the government) this imo will be already in hand. You will recall we discussed this previously.
"You ARE wrong RegulatorUK and you have repeated your "understanding" despite having been corrected by me!"
So... do we (Avacta) have a CE marked test yet? Or one that's made it through the PHE evaluation process.
Errr... no.
You ARE wrong RegulatorUK and you have repeated your "understanding" despite having been corrected by me!
"If thats the case Regulator then my knowledge is outdated."
I may be wrong - but that's what I understood.
"The lack of a QMS backing the design was a big red flag to me when that product went to trial. Ive seen too many R&D companies with too much focus on the R if you know what i mean."
Oh yes...
No evidence for that statement regulator
If thats the case Regulator then my knowledge is outdated. The lack of a QMS backing the design was a big red flag to me when that product went to trial. Ive seen too many R&D companies with too much focus on the R if you know what i mean.
I though PHE reran the test with fresh collections and they still failed?
tbf i think AVCT had a point with that as their test targets the S protein and porton down were using frozen samples. Its known that the S protein is very vulnerable to damage by freezing. It does make it difficult to evaluate though as fresh collections required.
That’s avacta buggered then. Last time failed and started blaming portion down and their ‘samples’.
sounds like an IVDR halfway house. I like the part where they aim to allow purchases to compare data on the products
The Government is holding a consultation on requiring all Covid tests offered for sale in the UK to be subject to independent validation: https://www.gov.uk/government/consultations/private-coronavirus-covid-19-testing-validation/private-covid-19-testing-validation
The idea is to weed out the less accurate tests being offered for sale in the UK, i.e. ones that have been CE marked but are not reliable enough. Personally, I think it's a good idea - anyone wanting to sell tests should demonstrate they meet minimum criteria via independent assessment.
ODX would be OK, as would the likes of Mologic and Abingdon. Some of the others might struggle a little...