Atomo Diagnostics Nearly Doubles Pascal Cassette Supply Deal Amid US Market Surge
Atomo Diagnostics reports a significant expansion in its supply agreement with Lumos for the Pascal test cassette, tied to the promising CLIA waiver status of the FebriDx test in the US. This deal could nearly double Atomo’s revenues over the next three years.
- Pascal cassette shows over 99% concordance in US CLIA waiver trial for FebriDx
- Supply agreement with Lumos extended to June 2031 with committed revenues of US$3.4 million
- Potential increase in Pascal cassette orders to US$6.9 million over first three years
- Lumos projects FebriDx US sales up to US$313.5 million over six years with CLIA waiver
- Atomo remains exclusive supplier and is negotiating additional supply under PHASE Scientific deal
Strong Clinical Validation Boosts Confidence
Atomo Diagnostics Limited has revealed encouraging results from US clinical studies involving its Pascal test cassette, which is integral to Lumos Diagnostics’ FebriDx rapid diagnostic test. The Pascal cassette demonstrated exceptional performance, achieving over 99% concordance between trained and untrained operators in a pivotal CLIA waiver trial. This milestone is critical as it supports Lumos’s application for a CLIA waiver from the US Food and Drug Administration (FDA), a regulatory status that would significantly broaden FebriDx’s accessibility in point-of-care settings.
Expanded Supply Agreement Reflects Growing Demand
Following the positive trial outcomes, Atomo and Lumos have amended their supply agreement for the Pascal cassette, extending it through to June 2031. Initially, the deal committed Atomo to revenues of US$3.4 million, contingent on FebriDx securing the CLIA waiver. However, recent updates indicate that anticipated demand could nearly double this figure to US$6.9 million over the first three years alone. This surge reflects strong market confidence in FebriDx’s potential and the critical role of Atomo’s Pascal cassette in delivering reliable, user-friendly testing.
Strategic Partnership with PHASE Scientific
Lumos’s exclusive six-year US distribution agreement with PHASE Scientific underpins the expanded demand forecast. Lumos projects that FebriDx product sales could reach up to US$313.5 million over the contract term, assuming the CLIA waiver is granted and minimum order quantities are met. Atomo, as the exclusive licensor, manufacturer, and supplier of the Pascal cassette for FebriDx, stands to benefit substantially from this growth. Discussions are ongoing regarding additional Pascal cassette supply to support the PHASE agreement, which would further enhance Atomo’s revenue streams.
Market Implications and Future Outlook
Atomo’s Managing Director, John Kelly, highlighted the importance of the Pascal cassette’s performance in securing regulatory approvals and meeting market needs for ease of use and reliability. The company’s unique integrated test devices continue to position it well within the competitive rapid diagnostic testing landscape, particularly in infectious disease detection. While the revenue projections are promising, they remain dependent on regulatory outcomes and contract fulfillment, factors that investors will watch closely in upcoming quarters.
Bottom Line?
Atomo’s expanded Pascal cassette deal signals strong US market traction, but regulatory and demand milestones remain key to unlocking full value.
Questions in the middle?
- When will the FDA announce its decision on the FebriDx CLIA waiver application?
- How will actual order volumes from Lumos and PHASE Scientific compare to the minimum contracted quantities?
- What additional opportunities might arise for Atomo’s Pascal cassette beyond the current FebriDx partnership?
