How Atomo’s FebriDx FDA Bid Could Transform Infectious Disease Testing
Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.
- FebriDx submitted for US FDA CLIA waiver with over 99% user concordance
- Pascal cassette sales exceed $1 million since agreement with Lumos and PHASE
- Active Syphilis test shows market-leading specificity in preliminary clinical data
- HIV Self-Test launched on Chemist Warehouse ecommerce and orders from USAID
- Raised approximately $1.3 million in new capital to support operations
Strategic Regulatory Advances
Atomo Diagnostics has made significant strides in its regulatory and commercial agenda during the first quarter of fiscal year 2026. The company submitted its FebriDx test to the US Food and Drug Administration (FDA) seeking a Clinical Laboratory Improvement Amendments (CLIA) waiver. This submission is underpinned by robust clinical trial data demonstrating over 99% concordance between trained and untrained users, a critical factor for point-of-care diagnostics aiming for broad accessibility.
The anticipated CLIA waiver for FebriDx could unlock substantial market opportunities, with Lumos Diagnostics projecting potential sales of up to US$313 million over six years contingent on approval and minimum order quantities. Atomo has already received Pascal cassette orders exceeding $1 million, reflecting strong early commercial traction.
Innovations in Infectious Disease Testing
Beyond FebriDx, Atomo is advancing its Active Syphilis test, developed in partnership with the Burnet Institute and supported by a $2.44 million Commonwealth Government grant. Preliminary clinical data reveal the test’s exceptional specificity; 99% among never-infected patients; and sensitivity above 95%, positioning it as a potential first-in-class rapid test capable of distinguishing active infections from prior treated cases at the point of care. This capability addresses a significant unmet need in syphilis diagnostics, especially amid rising public health concerns in Australia and globally.
The company is preparing for clinical trials in Australia and regulatory engagements in multiple jurisdictions, including the US FDA and European bodies. Production tech transfer is underway to Atomo’s South African facility, aiming to scale manufacturing for upcoming trials and eventual market launch.
Expanding Distribution and New Product Development
Atomo’s HIV Self-Test has broadened its reach with a launch on Chemist Warehouse’s Australian ecommerce platform and new orders from USAID for distribution in Ukraine. Positive feedback from retail customers in Newfoundland further validates the product’s market acceptance.
Additionally, Atomo introduced its Florey clip-in accessory device at major US point-of-care diagnostic conferences. Designed to integrate with existing approved tests, Florey aims to simplify user experience and reduce regulatory barriers for adoption, potentially opening new OEM partnerships.
Financial Position and Leadership
Financially, Atomo reported unaudited revenue of $680,000 for Q1 FY26, primarily from HIV test sales, Pascal OEM sales, and development fees. Cash receipts totaled $2.27 million, bolstered by a $1.3 million capital raise completed during the quarter. Operating costs were managed at $1.3 million, with cash on hand standing at $3.39 million at quarter-end, providing a runway of approximately three quarters at current burn rates.
Leadership changes include the appointment of Patrick Cook as Chairman, signaling strengthened governance as the company scales its operations and commercial efforts.
Bottom Line?
With regulatory milestones and capital secured, Atomo is poised for accelerated growth but must navigate the timing of FDA approvals and market adoption challenges.
Questions in the middle?
- When will the FDA grant the CLIA waiver for FebriDx, and how will this impact sales ramp-up?
- How quickly can Atomo scale manufacturing and distribution for the Active Syphilis test post-clinical trials?
- What new OEM partnerships might emerge from the Florey accessory device’s regulatory engagement?
