Atomo Faces Production Pressure Amid Lumos’s US FebriDx Expansion
Atomo Diagnostics has secured a US$410,000 order from Lumos Diagnostics for its Pascal test cassettes, following Lumos's exclusive six-year US distribution deal for the FebriDx test with PHASE Scientific.
- US$410,000 Pascal cassette order from Lumos
- Lumos's six-year exclusive FebriDx US distribution with PHASE Scientific
- FebriDx holds FDA 510k clearance and nearing CLIA waiver
- Potential US$316 million sales over six years projected
- Atomo positioned to scale production for growing US demand
Strategic Order Signals Growing US Demand
Atomo Diagnostics Limited (ASX, AT1) has announced a significant order worth US$410,000 from its strategic partner Lumos Diagnostics (ASX, LDX) for the supply of Pascal test cassettes. This order is a direct consequence of Lumos securing an exclusive six-year distribution agreement with PHASE Scientific to supply the FebriDx test across the United States.
The FebriDx test, which utilises Atomo’s patented Pascal cassette technology, is designed to improve usability and reliability in point-of-care diagnostic settings. It has already received FDA 510k clearance and is currently progressing through a Clinical Laboratory Improvement Amendments (CLIA) waiver study expected to conclude this month. The CLIA waiver is a crucial regulatory milestone that would allow the test to be used more broadly in non-laboratory settings, potentially accelerating adoption.
Long-Term US Market Opportunity
Lumos anticipates that the PHASE Scientific agreement could generate up to US$316 million in FebriDx product sales over the six-year term, contingent on the successful CLIA waiver and meeting minimum order quantities. This forecast underscores the substantial commercial opportunity for Atomo’s Pascal cassette, which Lumos exclusively licenses from Atomo for the FebriDx product.
Atomo’s Managing Director John Kelly expressed optimism about the partnership, highlighting the company’s readiness to support Lumos’s supply chain and scale production to meet the anticipated surge in demand. This order marks the first since Lumos’s exclusive distribution deal, signaling the beginning of a potentially transformative phase for Atomo in the US diagnostics market.
Broader Implications for Atomo
Atomo is an Australian-based medical device company known for its innovative rapid diagnostic test devices that simplify testing procedures and improve reliability. Beyond FebriDx, Atomo has a portfolio targeting infectious diseases such as HIV and Syphilis, as well as applications in pregnancy detection. The Lumos deal and the associated US market expansion could serve as a catalyst for Atomo’s broader growth ambitions in global point-of-care diagnostics.
While the order and partnership represent a positive development, the ultimate impact will depend on regulatory approvals and commercial execution. Investors will be watching closely for the outcome of the CLIA waiver study and Lumos’s ability to ramp up sales in the competitive US diagnostics landscape.
Bottom Line?
Atomo’s US$410K order is just the opening act in what could be a multi-million-dollar US market breakthrough.
Questions in the middle?
- Will the FebriDx test secure the CLIA waiver as expected this month?
- How quickly can Atomo scale production to meet potential US demand?
- What are the risks if Lumos fails to meet minimum order quantities under the PHASE agreement?