@HongKongPhooey and @2105, I'll continue the discussion on the...

@HongKongPhooey and @2105, I'll continue the discussion on the biochip testing regime here.

we have a gFET sensor which will be testing for K (potassium) initially. In addition, other ions need to be identified as being present/absent in patients. This is where the multiplexing on the biochip is going to offer more thorough blood work up as a lab does, except quicker and easier and cheaper. This is the unique value prop. We are only starting with K detection now.

the TGA and FDA and global bodies classify anything that comes near a human to measure, including a thermometer as a medical device. In AXE biochip case it will eventually be a device that can help diagnose and prevent. Everything involves testing in a clinical environment. For ethical reasons as well as for under the right conditions. There are varying regimes and stages for testing. At this starting phase of testing the gFET sensor for K detection might initially require a pilot test of 5-15 subjects lets say. But that sample size is only enough for device design tweaks, but I daresay our biotech team will want more data than this. So have to go onto sample of 100s for performance verification, randomised testing and at this stage comparative testing with other methods. We are still not talking about looking at commercial roll out. Commercial goal setting, yes. There will be no point in proceeding if the TGA is not kept abreast of testing at every stage and for this to happen, I believe it has to be in a hospital environment to start with. Expecting more updates of the whole testing requirement. But no short cuts allowed I'm afraid.