• FebriDx submitted to US FDA for CLIA waiver, with Pascal validated in US clinical trials
• Atomo receives ~$1 million in purchase orders from Lumos for Pascal cassettes
• Preliminary data for Pascal Active Syphilis test demonstrates market-leading specificity

Atomo Diagnostics Limited (ASX: AT1) has released its Appendix 4C and quarterly activity report for the three months ended 30 September 2025 (Q1 FY26). Key highlights include: FebriDx submitted to US FDA for CLIA waiver, enabled by excellent Pascal performance, with Pascal validated in US clinical trials as delivering greater than 99% concordance between trained and untrained users. Atomo receives purchase orders from Lumos totalling ~$1 million since the signing of the FebriDx agreement, as Pascal scale up commences. Preliminary clinical data for Atomo's Pascal Active Syphilis test demonstrates market leading specificity, positioning it to be the first rapid test capable of reliably distinguishing between active and prior treated infection at the point-of-care. HIV Self-Test channels expand with the test being launched through the Chemist Warehouse ecommerce site in Australia and an order received from USAID for Ukraine. Atomo's Florey clip-in device presented at two US diagnostic POC conferences as a user accessory developed for existing standard tests. Atomo receives a further ~$1.3 million in new capital, to be used to meet working capital requirements and funding of ongoing business objectives. Revenue for Q1 FY26 was $680k, consisting of HIV test sales, OEM Pascal sales and development fees. Cash receipts were $2.27m, with cash on hand at quarter-end of $3.39m.

Lumos previously indicated that it expects the agreement with PHASE to generate FebriDx product sales of up to US$313 million over the six-year term, assuming CLIA waiver is granted and contracted MOQ's achieved. Each FebriDx test sold to Phase requires Lumos to order a Pascal cassette, with Atomo receiving a percentage portion of the proceeds based on the transfer price of Pascal.