Would be quite something if they'd managed to create fake...

Would be quite something if they'd managed to create fake results across 7 studies, the final one covering 12 hospital based trial sites, 989 patients. The whole thing coordinated by multiple 3rd party partners including CRO Accelagen, and Sonic Clinical Trials. I'm pretty sure it's proven to work!

They fell down with TGA because not enough evidence was provided to prove that it's reproducible across multiple batches. It most likely can achieve the required batch consistency (IMHO), but TGA has extremely high standards, especially for public health screening devices.