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Pinned straw:

Added 10 months ago

Strawman Straw LDX, Lumos Diagnostics Holdings is involved in Point of Care diagnostic tests and related services.

MCap ~$38m AUD

Cash on hand ~$6.4m USD plus $5M USD due end of June.

SOI:481M

Price: 7.9 cents

Analysis - Lumos originally floated in July 2021 at AUD $1.25 (MCap $140M AUD) however due to not gaining FebriDx regulatory approval and costs associated with the planned launch scale up, the share price has been heading downwards ever since and reached a low of 1 cent in June 2023.

In July 2023 Lumos did receive FDA approval for its FebriDx test, albeit for Emergency Use only in specific settings. This news rocketed the share price to an intraday high 17.5 cents and since then the price has been in the 6-10 cents range.

In September 2023 Lumos also recieved Emergency Use Authorisation for ViraDx.

The focus of the business now is to commercialise the sales for FebriDX, which started pipeline fill across the US in December.

In addition, early January saw the signing of a $14,7m USD agreement with Hologic, which comprises $10M USD IP sale for a specific application and $4.7M USD to convert a product to the Lumos reader and enhance its technology. Doug Ward described this agreement as "transformational" for the company. 

Doug used to be the VP of Strategy and Business Development over at Hologic before moving to Lumos and so he would have good relations with their team and insights into what they need and how Lumos can best assist them.

Doug recently did an investor briefing that explained things in more detail and he will be out in Australia soon, doing a roadshow.

The Company seems to be pulling in the right direction and the upside will come from getting the full FebriDx FDA approvals in place. 

It is unclear where this is upto, but certainly clinicals and a resubmission to the FDA would be involved. Given the emergency use approval was 9 months ago then this could be progressing well and would just be a matter of time to getting these final approvals.

I was able to source all the information from the Lumos website and they have some useful product videos on there as well.

This training page has a useful video of a FebriDx unit in use.

The IPO document also has a lot of still relevant background material on the market, antibiotic resistance, competitors etc.

Chagsy
Added 10 months ago

Thanks @markeewan

I hadn't heard of this product. It seems a real shame they didn't get this out in time for Pandemic, as I suspect it would have sold like hot cakes. There are a number of studies I found looking at its utility and seemed to be pretty supportive.

Currently, it is aiming to sell into the GP market, by the looks of things. It may well get some traction, as I can see the attraction. It should be noted it is only marketed at febrile illnesses that are respiratory in origin. But these account for most acute febrile illnesses that patients present with so represents a huge TAM.

I found one independent assessment of their product. The results and conclusion are pasted below:

 FebriDx had pooled sensitivity and specificity of 84% (95% CI 75%-90%, k = 4) and 93% (95% CI 90%-95%, k = 4) for bacterial infections, and 87% (95% CI 72%-95%; k = 4) and 82% (95% CI 66%-86%, k = 4) for viral infections, respectively.

Conclusion: Combinations of biomarkers show potential clinical utility in discriminating the aetiology of RTIs. However, the limitations in the evidence base, due to a high proportion of studies with high risk of bias, preclude firm conclusions. Future research should be in primary care and evaluate patient outcomes and cost-effectiveness with experimental study designs.

So from a statistical point of view, although the percentages all look high, this is actually quite an inaccurate test. There are plenty of other inaccurate tests that get used all the time in medicine, so that may not be a barrier to uptake, but I suspect there is a long way to go before there is a more generalised uptake and that will probably require multiple more trials and HUGE expense. Cap raise after Cap raise after dilution etc with no guarantee of success.

Interesting to keep an eye, but uninvestable for me

C

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