Ann: Atomo receives TGA approval for COVID19 antibody test, page-104

FYI update on the Peter Doherty Institute (PDI) led 'Post market review of COVID-19 POCTs'

As a recap, AU TGA (like many regulatory auth) is emergency approving Covid19 tests (based on certified manufacturer’s evidence + studies provided at the time of application). So its delegated the PDI to:
- test in-depth (post-approval) all the test types ie: it actually does what the manufacturer/importer 'said' it does
+ inform the AU TGA/gov on their best usage (since all testing for now is AU gov managed/co-ordinated).

The TGA approved AT1 brand (Access Bio antibody) test is now showing as 'submitted' to the PDI for review - must have been in the last 7days, as I was checking weekly. Unsure when its review will be completed (<1-2mths?).

https://www.tga.gov.au/post-market-review-covid-19-point-care-tests


As you will see under 'POCT' filter, PDI has so far reviewed 9 manufacturer tests (they release 3-4 tests in 1 report; 3 reports since Apr2020). They are being really thorough - looking at the box labelling, packaging consistency, included instruction clarity + the accuracy of the tests against multiple known AU patient samples, 0-30days efficacy etc.

PDI's reports clearly summarise stuff like - whether it has 'confusing' steps, did the sponsor/importer provide enough samples, test accuracy in reality VS the advertising/ideal conditions for use etc

Out of 39 tests submitted for review (since Apr2020), 8 POCT tests have backed out of TGA approval completely (dunno whether due to this stringent review or for some other supply reason). In the 3 reports, for many of the 9 tests, accuracy % was found below the manufacturer's advised levels. One antibody POCT was so significantly low well, even beyond 14day ideal timeframe...that I reckon the importer withdrew it from AU market after review.

As an Australian, I am v happy to see the PDI's in-depth reviews, because it gives confidence the tests to be used here are going to be best-in-class. I don't see the US FDA even doing this level of post-approval checks...and they have 140+ EUA POCTs already.

As an AT1 investor - I am really hoping Access Bio's tech + prior testing + studies are on the mark ....because the PDI review here, will shape how much AT1 is able to market in AU (whether for Covid19 related testing or post-vaccine; AT1 had planned initial 100k mth production for AU)