Welcome MA. The regulatory approval process and landscape is...

Welcome MA. The regulatory approval process and landscape is very different for IVD's (in vitro diagnostic devices) No long drawn out TGA or FDA approvals we see in most biotech companies. Much quicker process for IVD's which are intended to be used for the testing of human samples, where the results can assist in clinical diagnosis or management. However, the laboratory must comply with the conformity assessment procedure prescribed under the Therapeutic Goods (Medical Device) Regulations 2002, which requires that the laboratory be accredited by NATA as a medical testing laboratory that complies with ISO 15189 standards and with the National Pathology Accreditation Advisory Council (NPAAC) standard titled. The hard part has been done over the last 14 years developing the test and carrying out the studies.

The below was found from the presentation in August last year. I feel it is left out of more recent presentation because the NATA accreditation is now well under way.

In the US, IVD's are accredited through the LDT pathway. Sonic healthcare have used this pathway for 100’s of diagnostics in the US. I will look further into this when I have more time.

I have also pasted the most recent results of testing from an announcement in August last year.