Sure isinteresting.
So do all readers havetwo electronic partsIf so would the TGA be responsible for just thecorrect medical functioning of the test (to a stated or proved level)and reader or do they have to guarantee the security aspects of bothe based components of the latter as well? The job is becomingcomplicated.
- the analyser
- the secured communication to a secured database.
Onthe more controversial aspect of TGAs role, it seems to me thatpractically all of Anteo's submitted data would have been based onprimarily Delta cases and maybe some very limited data on othervariants. This at a time when it was becoming obvious to all (exceptsome too far to the right politicians who think that the only way tosave an economy is to make sure that you have no workers leftavailable to work) that omicron was going to take over and threatenall the good work done to that time. I wonder whether if I werecharged with checking the sensitivity of testing whether I would wantdata on the old variants or the newer ones as well!
I also wonder if prospective testing on omicron is assimple as it sounds. While numbers are large my understanding is thatsequencing has been mainly aimed at ICUs etc for treatment purposes.No doubt researchers will be doing much more but when?
WhileI haven't examined it to PhD level I do have an impression that someof the companies with earlier approved tests seem to have been ableto provide satisfactory data on the earlier variants without too muchtrouble. This is apparently a task of the sponsoring company but whenI did some research in earlier times I was horrified by the lack ofexperience of a couple of the sponsoring companies. Newly formed,with very little or no experience in handling medical tests andpharmaceuticals. Some had been involved in mainly equipment andclothing etc. Obviously the manufacturers were supporting them inthis monitoring role and I would assume were aware of therequirements to address variants as they arose.
Atthe time when a rush of approvals coincided with NSW contracts Ibecame interested in who was doing the validations. I wasaware that data was manufacturer provided but I thought the labsinvolved did have to have some international accreditation. I managed to track down some specs on a Chinese test which statedvalidation carried out by an Italian lab? I wondered why this mightbe so but then thought that Anteo had tasked its validation to Spanish and Chinese labs(the latter I can't find reference to in anyAnteo release since and I have asked twice on HC for any info that Imight have missed and drew a blank both times – in my opinion quitedisconcerting when the intention to pass on the task was the part ofa ASX announcement!!) I guess SH have to be satisfied by statementsmade on HC that Anteo's product is reverse engineered proof. I'vealso wondered whether in any of the approval regimes worldwide isthere any check that the technology stated to be the basis of thetest is in fact as described?? Who plays the role of patent police?
Finally, although not a SH, I still confess tobelieving that the Anteo test has a role to play in the long term butmore likely in its multiplexed form. Just how long this term willprove to be was brought into focus when I recently finished reading a2021 published book on the life and work of the medicine Nobel 2020winner. The potential human gene editing technology has beendeveloped by many co-operating researchers to provide a testingregime and even virus destroying technology. (I am apparently notallowed to promote the book by name/author but you have enough infohere to track it down if you are interested in where things might beheaded. Its an excellent read )
Of course all of this IMO and DYOR.
PS From a couple of recent posts I have becomeaware that non shareholders are not allowed by some to have anopinion because they have ulterior motives! Of course none of thatapplies to SHs??
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