Companies / Lumos Diagnostics

Medical device company profile

Lumos Diagnostics

Point-of-care diagnostics company combining the FebriDx host-response test with development and manufacturing services.

Medical Device ManufacturerDiagnostics & ImagingIn Vitro DiagnosticsCommercial-stage

Headquarters🇦🇺Australia

FoundedNot confirmed

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Disclosed fundingA$20 million ^[9]Completed placement · Mar 2026

Official websitewww.lumosdiagnostics.com ↗

Company overview

Lumos Diagnostics develops and manufactures rapid point-of-care tests and provides assay, reader, software and contract-manufacturing services. Its lead branded product, FebriDx, measures host-response markers from a fingerstick sample to aid differentiation of bacterial from non-bacterial acute respiratory infection.

FebriDx is an aid to clinical assessment, rather than a test identifying a particular pathogen. FDA records document an initial June 2023 clearance and a March 2026 decision. The company subsequently announced a CLIA waiver, expanding the settings able to perform the test under applicable requirements.

Doug Ward is CEO and Managing Director, with Paul Kase as Chief Commercial Officer. The Australian-listed group’s commercial model includes a U.S. distribution relationship with PHASE Scientific alongside its development-services business. Order announcements are commercial signals, not equivalent to recognized revenue or guaranteed end-user demand.

^{[9][10][13][14][15][16][17]}

Leadership

4 people

Doug WardChief Executive Officer & Managing Director ^[15]

Paul KaseChief Commercial Officer ^[15]

Sacha DopheideChief Technology Officer ^[15]

Barrie LambertChief Financial Officer ^[15]

Products & regulatory status How does MedTechIndex get this information?

Summary

FebriDx has matched 510(k) decisions K230917 and K260787. Lumos reports the later clearance includes a CLIA waiver, broadening eligible U.S. testing settings. That change does not automatically establish pediatric or other indications beyond the current labeling. ^{[17][11][12][16][3][2][10][15][1]}

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. ^[7][5]

Regulatory snapshot How to read this snapshot

U.S. FDA

2
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Host-response point-of-care assay

FebriDx ↗

Lateral-flow assay measuring CRP and MxA; supports bacterial/non-bacterial assessment, not pathogen identification. ^[17][11][12]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Commercial development

Commercial FebriDx with company-reported CLIA waiver. Pediatric development and additional claims are not generalized beyond current labeling. ^{[17][11][12][16]}