TGA submission is going through its process and Q4 is still the expected approval period.
What I have discovered is the actual POC device is approx $8.5k per unit, must be managed by a "health care professional" and the definition is ever changing by the Pathology Association. Best on market today, a lot of attention, all are eagerly awaiting TGA approval as any trial testing cannot be publicly announced or used as basis of clearance yet.
