General Discussion - News - Questions

I sent an e-mail to them a few days ago but haven't heard from them yet. So, why not I leave those questions here? Let me know what you think.

Lumos Diagnostics submitted an application for CoviDx around 7 months ago. Considering all the Covid rapid antigen test applications are being expedited and the current timeframe for approval is approximately 1-4 months, why hasn't Lumos Diagnostics received an approval from the TGA after 7 months?

FebriDx was approved by the TGA on the 27th of October 2020, and currently available for sell in Australia. How many sales has Lumos Diagnostics made from their FebriDx test in Australia? Since FebriDx is approved in Australia, why is there a clinical trial being conducted at Box Hill Emergency Department?

In response to my query following the Victorian government announcement I received this reply from LDX:

Please note that the self-test application is a separate application to the one that was previously lodged with the TGA and therefore, we will need to go through the process and monitor the level of engagement / prioritisation. The Vic government has been helpful in our discussions with the TGA to date and we hope to that this arrangement continues to help progress the initiative.

Unfortunately as all the FebriDx tests are produced in USA there is no accounting requirement for a breakdown of sales by region. Depending on the level of sales and interest from investors the company could choose to voluntarily disclose this information, and if they did then the most likely vehicle for such information would be their annual report and/or corporate presentations.

There is no need per se for Box Hill Hospital to have to perform clinical trials of FebriDx but they would likely wish to trial the benefits of the usage for themselves before deciding whether to commit to a broader roll out as a health care solution for their patients.