Atomo Diagnostics (ASX:AT1) Raises A$4m as FebriDx CLIA Waiver Unlocks Pascal Volume Upside

Atomo Diagnostics A$4m Raise Funds Scale-Up as FebriDx US Rollout Accelerates

Atomo Diagnostics has just completed a fresh capital raise to fund growth. The company raised A$4M through a A$3M placement and a A$1M share purchase plan.

The new shares were issued at 3.3 cents each, which represented a 10% discount to the company’s 15-day moving average. That discount helps the company secure funding quickly, although it is still mildly dilutive for existing shareholders.

The capital is being used to support the commercialisation of Atomo’s own diagnostic products, including Active Syphilis and liver function testing. It will also help scale operations to meet higher demand for Pascal cassettes used in Lumos’ FebriDx product in the US, which means we should expect some working capital investment as volumes build.

What are the Best ASX Stocks to invest in right now?

Check our buy/sell tips

How does the Atomo Diagnostics technology work

Atomo’s technology is a simple but important design improvement aimed at making diagnostic devices easier to use, more reliable, and more accurate. The key value sits in the delivery mechanism, which is especially important for DIY diagnostic kits where the user often has no medical experience.

Pascal is one of several products in Atomo’s portfolio, but it is the one currently gaining the most commercial momentum. It is the cassette used with Lumos’ FebriDx product, and Atomo has said Pascal played a major role in making FebriDx simple and reliable enough for untrained users. That was an important factor in supporting the product’s FDA CLIA waiver approval in the US.

That matters because many diagnostic tests are only truly valuable if they can be used outside specialist laboratories. If Atomo’s device makes testing easier and more dependable, then customers are more likely to adopt it because it improves usability without compromising performance.

FebriDx test has received FDA CLIA waiver approval in the US

The most important part of this announcement is the commercial distribution of the FebriDx product. FebriDx is sold using Atomo’s patented Pascal cassettes, and Atomo is the exclusive licensed manufacturer and supplier.

The FDA waiver approval is important because it allows FebriDx to be used across a much broader range of healthcare settings by less specialised staff. That expands the potential customer base and gives the product a much better pathway to scale.

For Atomo, that matters because higher FebriDx adoption should translate directly into higher cassette volumes. If FebriDx sales grow, Atomo should benefit because it supplies the Pascal cassette used in every test.

What financial upside did Atomo highlight?

Since the Phase Agreement was signed in July 2025, Atomo says it has already received US$1.57M of Pascal orders from Lumos.

Atomo also notes that the agreement includes committed Pascal revenue of US$3.4M, or around A$5.2M, contingent on FebriDx receiving CLIA-waived status, which has now been achieved.

The Investors Takeaway for Atomo Diagnostics

In our view, the successful placement gives shareholders a clearer view of the next phase of growth. With the FDA waiver approval now in place, Atomo has a much stronger pathway for its product line to reach a broader distribution network, which could translate into meaningfully higher volumes and potentially more commercial partnerships.

Investors should also note that the issue of new shares is mildly dilutive, which was reflected in the market’s initial reaction this morning.

Based on this announcement, we think there could be meaningful upside from here.

Pitt Street Research Directors owns shares in Atomo Diagnostics. This article reflects personal views and is not financial advice.