Atomo Diagnostics (ASX:AT1) has secured a significant new order for its patented Pascal cassette, with strategic partner Lumos Diagnostics (ASX:LDX) placing a US$410,000 (A$630,000) order to support increasing demand for the FebriDx® test in the United States.

This is the first Pascal order since Lumos entered a six-year exclusive US distribution agreement with PHASE Scientific, signalling a potential step change in sales volumes for Atomo’s technology.

FebriDx Positioned For Scale In US Healthcare

The FebriDx® test is designed to quickly differentiate between viral and bacterial infections at the point of care – a function that is highly sought after in frontline healthcare settings. The test uses Atomo’s Pascal cassette, an integrated device designed to improve usability and reliability.

The product has already received 510(k) clearance from the US FDA and is nearing completion of a CLIA waiver study, which, if granted, will allow broader use in non-laboratory settings across the US.

Lumos has indicated that the agreement with PHASE could generate up to US$316 million in FebriDx sales over six years, provided the CLIA waiver is secured and contracted minimum order quantities (MOQs) are achieved.

Atomo MD Welcomes Long-Term Demand Visibility

Atomo Managing Director John Kelly said the company is well prepared to meet growing demand:

“We are very pleased to see demand for Pascal locked into a sizable long-term contract in the US market,” Kelly stated.

The order is strategically important for Atomo, not just in terms of revenue, but also in establishing the Pascal cassette as a key component in a large-scale US healthcare rollout.

“[We] stand ready to work with Lumos to support supply of Pascal into Lumos’s supply chain and scale up of operations to meet demand for FebriDx,” Kelly added.

Strategic Relationships Turning Into Revenue

Atomo is the exclusive licensor, manufacturer, and supplier of the Pascal cassette to Lumos for the FebriDx product. This gives Atomo a direct supply chain role in what could become one of the most widely used point-of-care infection differentiation tests in the US market.

With the FebriDx CLIA waiver study expected to be completed later this month, investors may soon gain more clarity on the scale and timing of demand growth.

What This Means For Atomo Shareholders

The US$410,000 order represents an early indication of the commercial potential for Atomo’s Pascal technology under the Lumos–PHASE Scientific agreement. If the anticipated growth in FebriDx sales materialises, Atomo stands to benefit significantly as the sole supplier of the Pascal cassette.

The announcement marks a key milestone in Atomo’s shift from product development to consistent commercial supply – particularly in the large and highly regulated US market.

About Atomo

Atomo Diagnostics is a Sydney-based medical device company focused on simplifying rapid diagnostic testing. Its patented, integrated test platforms are designed to improve usability and reliability in both point-of-care and at-home settings.

Atomo has active supply agreements for diagnostics covering infectious diseases such as HIV and Syphilis and continues to grow its footprint in global markets.