Ann: Victorian Government Intent for Lumos Manufacturing Hub, page-15

The TGA keep moving the bar for new RATs to get approved.

What is now required to get TGA approval 31/1/2022
https://www.tga.gov.au/sites/default/files/covid-19-rapid-antigen-self-tests.pdf

All the RATs that are currently been sold in the Australian market didn't have to go through all these validations. That's why some of the RATs on the market many not be of very high quality.

Anteotech is in a similar position in getting TGA approval.
https://hotcopper.com.au/asx/ado/
There seems to be a lot more people on the ADO thread following the TGA approval process as well.

If LDX gets TGA approval this share will launch. The TGA approval will be very similar the new standard in Europe. Until then most countries will not look at LDX. It's impressive that LDX got into Canada and UK.

From Anteotech 4c update
"In Australia, the TGA has adopted a guidance note from the European Commission’s Medical Device
Co-ordination Group (MDCG) on the clinical performance evaluation of RATs. The MDCG
requirements underpin the new European In Vitro Diagnostic Regulations (IVDR) that focus on test
efficacy using prospective sampling in the 0 – 7 days post-onset symptoms range. A prospective trial
involves the recruitment of patients for direct harvesting of samples to be tested on the EuGeni
platform for SARS-CoV-2 Ag RDT1"

It will be interesting to see if LDX provides an update on how the TGA submission is going.