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Ann: TGA Registration Update, page-112

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  1. 4,995 Posts.
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    I think I agree with you on this on @Eddie30.

    The TGA has now seen all of our data and results from MULTIPLE real life clinical trials from around the world (which most other RATs probably hasn't done any apart from in-house trials) and realised EuGeni is just as good as a PCR test, and they'd want us to just confirm that we can pick up Omicron and other variants before approving and possibly pushing it as the gold standard RAT.

    In terms of the ability of variant detection, I think MS knows the science and/or the test much better than most of us, and for him to say this isn't an issue, I'd take his words for it.

    Therefore, what's left for us to provide is a future-proofing plan for EuGeni on different future variants, just to give the TGA a peace of mind that we will continuously monitor new variants and to make sure EuGeni is up to scratch with what it can detect. Which I'd think other Chinese tests will just get TGA stamped and not care about anything other than revenue, regardless if their tests work or not.

    It is a shame that there's a delay, but if we can prove detecting different/new variants will not be an issue, then I think we'll be good to go and knowing we won't be facing recalls or reprecussions of a dud test - like many others on the market.
 
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