Analysing the news and assuming that the TGA are not deliberately putting hurdles in the way.
AnteoTech Ltd (ASX: ADO) (“AnteoTech” or “the Company”) advises that following the submission last week of the additional information requested by the Therapeutic Goods Administration (TGA) in December [ASX 15 December 2021], the Company has received a request for further information on its EuGeni Reader and SARS CoV- 2 Ag Rapid Diagnostic Test (RDT)1 submission.This doesn't necessarily mean that there were reader-specific questions. Both need to be approved separately, but the submissions rely on each other so they're being looked together.
The most recent request primarily relates to the collation of additional clinical data, together with other aspects of information.ADO submitted data/information from multiple sources. TGA want it all on the same piece of paper instead of wading through multiple pages and having to cross-reference
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The TGA continues to work collaboratively with AnteoTech to work through the specifics of the request and how best to address the clinical data requirements.They didn't just tells us "rejected, submit again with more data"
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This will allow the Company to determine the expected timeframe needed to gather the additional information and fulfil the conditions of the TGA’s guidelines.The next update won't be for a little while. ADO need time to draw up a bulletproof plan of attack.
AnteoTech has recently supplemented its EuGeni studies by conducting a prospective clinical trial at the Department of Infectious Diseases, Clinical Research Unit at the Alfred Hospital and Burnet Diagnostic Initiative (BDI) at the Burnet Institute in Melbourne to further evaluate the clinical performance of the EuGeni SARS- CoV-2 Ag RDT.The TGA don't believe our sensitivity claims, or they need it broken down into specifics such as Cq<25, Cq>25 <30, Cq >30. This could possibly be for them to create a group of 'gold standard' tests that exceed the capabilities of their current ranking system. And they want to be 100% sure that this is the reality, especially if they plan on reducing supply by kicking out substandard tests. Currently, the highest sensitivity is 'Very high sensitivity - clinical sensitivity greater than 95% PPA'.
The Cq thing could also be a set of new requirements for all manufacturers, to allow better differentiation of tests rather than just a rudimentary sensitivity figure. It's how the Germans do it and I've seen a test on the ARTG provide a table with that data in the IFU. If international standards for covid testing are being developed, then this would make sense. If this IS the case, then why are we made to jump through those hoops first? Perhaps as we provide software/connectivity so we're the 'full package' not just a self-use cassette.
We anticipate that the trial will provide any further data that may be required to meet the clinical data requirements set by the TGA. However, the current Omicron wave and the staffing strain on the health system, including clinical research organisations, is currently impacting the timeline of the study.This will finally result in approval. But it will be somewhat delayed. Do remember that in one of the interviews, Derek stated that data will be submitted but that he's unsure as to whether that will satisfy the TGA. They weren't sure then, but they seem to think that this is the cure to the situation.
If the 'further data' is not a Cq-related thing, then it could perhaps be related to specimen stability and resulting accuracy. we know that we can test up to 2 hours later, but maybe the TGA want hard data on that.
https://www.tga.gov.au/instructions-sponsors-who-have-interest-supplying-covid-19-self-test
AnteoTech will further update the market when more details and the required data gathering plans have been established.Don't bother us with endless e-mails. There is nothing more to say. wait for the update, your questions will be answered then.
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