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sdon, of course inside government help for innova has been there all along, how else??....but the favour is now being returned with a facility in Wales, Rhymney, that I think might turn out our test (as per PL75 idea) and Surescreen too. It is strange that Porton Down produced this to support innova https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf ....but I think that study under Falcon was seperate to the S/S evaluation staff and set up by BJ and Cummings to get round them. I don't think such a study will be needed for AffiDX as approved EU tests can be legitimately sold here.
I do think AS has cabinet backing and all is on course with the Innova profits now behind our roll out.

What is the latest eavesdropping chrisbak, surely been some celebration? Does PD get a mention? Successfully bypassed?

There will be challenges with the resistance of big pharma but for AS this is landing the first telling punch and he will be swinging freely from now on. PD only comes round to the moneyed players so will be changing their tune soon enough.

I think AVCT describe affimers as a phage which I believe is a naturally occurring molecule that occurs in millions of varieties but with potential to be an antibiotic(eg pencillin) and is different to a virus which has an ability to reproduce. An affimer /phage is engineered to detect antigens/viruses without a simultaneous blitzing effect like penicillin on meningitis but it is a new tool in the diagnostic locker. PCR does not have this function, it cannot attach itself like a phage /affimer and cannot therefore detect the infectious individual. A PCR can belatedly analyse a previously infected individual and erroneously call them infectious.
Sir John and his ilk should have fast tracked this new British diagnostic for use as first and only new viral diagnostic LFD in the doctors cupboard. It is not dangerous and can stop the spread of covid cheaply and as an aside, users would soon get accustomed to using a saliva version when most opportune without spoiling the result.

Big pharma are blinded by what has made them money and all or many top scientists cannot see fundamental truths. IMO I have just highlighted a glaring faulty process at PD. It is no wonder AS gets nowhere, he can't call them out as frauds as they hold the gate and the system an amateur can see is wrong is being pronounced with fanfare for being superlative just because they use it. Covid spreads easily in air currents. All those little spikes help catch the breeze and then catch on to a new host. A RT PCR is not building a new virion for quality but detecting a bit of RNA through amplification which indicates prior infection . A whole infectious virion needs to be detected to stop spread.

Due to the inherent variability in the quality of any quantitative PCR data, not only do reviewers have a difficult time evaluating these manuscripts, but the studies also become impossible to replicate.
https://en.wikipedia.org/wiki/Reverse_transcription_polymerase_chain_reaction

The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection
https://diagnostics.roche.com/global/en/news-listing/2020/roche-receives-fda-emergency-use-authorization-for-the-cobas-sar.html
Seems the Roche system has not had any CE/CV except results with their own staff. It as a RT PCR and the discoverer of that tech said it was not to be used for verifying infections but only for research. It does not quantify covid like affimers would- affimers with bams could count the virions? and not replicate bits of them and pretend they have a positives like Cobas 6800.
PD do not sample infectious cases imo

You can't give AS leeway-far too dangerous. Things are lining up for a superb launch of AffiDX but please don't give our CEO more time I won't be responsible for the consequences if there is more delay.

Theboardroom should be a good slanging match on occasions at AVCT to get the commercial side going. Too much respect and regulation following is typically british.

"We cannot scamper down a rabbit hole everytime we see a new variant."....So hoping he will come round to endorsing our test.

guarded- sorry for spelling error

AVCT BOD seem more alligned with members of LSE BB hence the cheery 10/5 rns. I hope new staff hired can do a better job than this so AVCT can take the reins. When revenue rolls I expect the in house confidence will grow. AS has gaurded his IP well and it might now pay off.

Ndn- I don't rate those certification experts in Bellas link very highly.

A DoC in Spain can be certified acceptable by the EU accross the EU-CE Certificate? (not sure but may be so called)

You'll get the hang of it eventually Ndn

CE mark binds the device to the acceptable test results. MHRA register the test as conforming if CEmark/ease of use data/loads of other stuff have the boxes ticked. CE mark is sef marking.

MHRA are the agency of registration and has nothing to do with CE mark. MHRA is the notified body in UK?

Ndn, Mologic are not going to CEmark it as they are contracted to AVCT only to CE/CV the test. CE marking will be a tick box exercise for AVCT once they have ISO. Of course MHRA would reject DoC when AVCT cannot tick the ISO box yet because Mologic also cannot transfer the CEmark and AffiDX test to them either. All the seperate elements are satisfied within the consortium but that is not a legal entity as far as MHRA are concerned.
DoC comes after CE marking as it is one of the boxes to be ticked.
CE mark is OK for professional use only

How about ISO for AVCT is required to be able to transfer AffiDX trademark IP from Mologic to AVCT and therefore the MHRA boxes cannot be ticked until ISO is done and the Mologic CEmarking and AffiDX branding become transferrable and AVCT the legally liable entity of the test. Trademark was attached to Mologic temporarily so that CE/CV could be done in EU/Spain to evade PD dullards.

rocquet, I know I have found it difficult to get my head around MHRA/PD/CEmark etc . Equivalence post brexit has been the trouble with UK wanting UKCA to be as good as CEmark and MHRA conformity seemingly to coincide with a Spanish(possibly)national conformity. AS owed an explanation due to the situation and not to mention Mologic's involvement and consortium guesswork too.

A stake in life is more important than chasing money but that is why a punt can be fun and a gamer can probably react quicker than most- taking the opportunities-good luck if invested.