Member Info for 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.

If thats the case Regulator then my knowledge is outdated.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.

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.

sounds like an IVDR halfway house. I like the part where they aim to allow purchases to compare data on the products

I'm using mine for asymptomatic testing as intended

Got my kits through the post. Innova. Get the stockpile down!

The bid i currently 20p over the ask on my screen. Mental times

If we are talking Asia Indonesia is actually the perfect environment for Point Of Care testing. Large population distributed over many islands leads to a distributed healthcare network. Perfect place for point of care if healthcare IT infrastructure for result reporting allows.

Just ordered some. Get the orders in and burn through that Innova stockpile :D

Since the absolutely wild swings appear to be over momentarily im finding the board to be a little quieter and more informative. Its also indicative that we seem to have stabilised somewhere between 80-100p which is also nice to see considering the volatility observed since Pfizer kicked us all solidly in the nuts.

It feels at the moment we have every piece of information except for the order numbers! I still think the realistic path forward, for the UK market, will be manufacturing mologic tests initially followed up by AVCT if their clinical validation is better and depending upon the outcome of the porton down testing.

Speaking of Porton Down they are taking their time. Im hoping this means that they have come up with a better reference testing methodology than simply using PCR results which as we know cause false positive results. There is an argument that you can stratify PCR results by stating that only results with a CT of <26 (indicative of a high viral load) are "true positives" however, being a pedantic scientist, this is also flawed as CT is affected by multiple factors in the testing process and not simply viral load of the sample.

Bit of a ramble but there we are. Happy Friday and GLA to all holders.

Regulator you can't be speaking facts like that. I can hear the trolls already

Even mystic meg got more correct predictions than levs

AUaddicted. My number 1 favourite scotch. Good taste my friend!

if it breaks a quid im having a beer. May as well top up from the long weekend

Wow thanks ChorleyPete! Heres a link

https://mologic.co.uk/mologics-covid-19-rapid-antigen-self-test-selected-by-nih-for-radx-initiative-funding/

Some welcome positivity

I've seen a lot of scientifically illliterate posts over the last year bit that one from goldilocks is up there with the best.

Hehe thanks tonic. We had a great day yesterday regardless in the good weather and i also got a job offer on something I've been in repeated interviews for across 3 months.

Let's just say her expectations are stratospheric now hehehe. Crazy day

Nice rally in omega from 12 hope it continues into the long weekend. Good luck tonic and all.