Ann: TGA Registration Update, page-1846

This is all about their Quality Management System being appropriately defined. What the TGA will want is some sort of documented internal procedure that sees a regular review of the WHO Variant of Concern list along with a specified process to retest the carts and reader against significant new variants. Partly this is because the TGA are concerned with actual or implied statements about efficacy - we are making a number of pretty strong claim for our product so we need to be able to show them that we are committed long term to keeping up with what happens.

So there is no requirement to make statements about variants that don't even exists yet - simply we must have a documented process to deal effectively with newly emerging variants as they occur - I imagine they are particularly concerned that if a variant emerges that we are ineffective against that we will fess up to that in a timely manner so the test can be removed from the market.

I don't doubt that we will readily meet these requirements and when (eventually) the cheap and nasty tests also have to meet these requirements it will provide part of the basis to weed out the crap tests and leave us standing near the head of a reduced field.

GLTAH.