Hi FDV, I had a phone call back from Shane Ryan who ran me...

Hi FDV,

I had a phone call back from Shane Ryan who ran me through the process at length (this was some months back, so I don't remember all the specifics) but my broad recollection is that I was satisfied by his responses and their method to get the test out into market. My understanding is that TGA/FDA approvals are not required at this point, as they are NOT trying to replace the standard of care, it is an additional test.

Approval as a stand alone test to replace mammography etc is something that will be pursued down the line. The test can and will be taken to market in Aus and US with the NATA (& US equivalent) accreditation, then the data collected (along with data collected to date) will be used for approvals to replace the standard of care/as as a stand alone test.

I would recommend speaking with Shane, he was helpful and approachable.

Looking forward to an update following the NATA inspection on the 30th.