Lumos Diagnostics
Lumos Diagnostics (ASX:LDX) is a point-of-care diagnostics company that develops and manufactures FebriDx, a rapid dual-biomarker test differentiating bacterial from viral respiratory infections, and provides contract development and manufacturing services for diagnostic partners globally.
- Company typePublic
- Founded2019
- HeadquartersCarlsbad, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Lumos Diagnostics does
Lumos Diagnostics Holdings Ltd (ASX:LDX) is a point-of-care diagnostics company headquartered in Melbourne, Australia, with an ISO 13485 certified manufacturing and R&D facility in Carlsbad, California. The company's core proprietary product is FebriDx, a rapid fingerstick blood test that uses a dual-biomarker lateral flow immunoassay combining CRP and MxA to differentiate bacterial from non-bacterial acute respiratory infections at the point of care, with FDA 510(k) clearance and CLIA waiver for patients aged 12–64 and an active pediatric extension study funded by BARDA. Results are available in 10 minutes using an instrument-free disposable test, with optional proprietary camera readers and companion Android/iOS apps that provide cloud connectivity, EMR integration, and data management.
Lumos monetizes through three primary revenue streams: (1) direct product sales of FebriDx via exclusive and non-exclusive distribution partners — PHASE Scientific holds exclusivity in the US under a six-year US$317 million agreement, while Henry Schein, Thermo Fisher Scientific, Amtech/YesGroup (ANZ), and a Baltic distributor handle other geographies; (2) contract development and manufacturing services for external diagnostic partners (assay development, reader platforms, app/cloud services, medical affairs, and quality/regulatory affairs), including commercial agreements with Micro-Pak for the Mold Analyzer system and Aptatek for PheCheck PKU monitoring; and (3) milestone and grant payments, including BARDA non-dilutive funding and distribution partner pre-payments (US$7.5M cumulative from PHASE Scientific). US reimbursement for FebriDx is set at US$41.38 per test under CMS.
The customer base spans urgent care centers, primary care clinics, retail pharmacies, emergency departments, community health settings, and university health services (e.g., WellStreet Urgent Care, Texas A&M). H1 FY26 revenue reached US$6.1M at a 68% gross margin with positive operating cash flow, and FebriDx product revenue doubled year-over-year as the company scaled toward the post-CLIA waiver US commercial launch backed by a fresh US$20M institutional placement.
Lumos Diagnostics firmographics
Firmographics- Name
- Lumos Diagnostics
- Legal name
- Lumos Diagnostics Holdings Ltd
- Website
- https://lumosdiagnostics.com
- Company type
- Public
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Lumos Diagnostics (ASX:LDX) is a point-of-care diagnostics company that develops and manufactures FebriDx, a rapid dual-biomarker test differentiating bacterial from viral respiratory infections, and provides contract development and manufacturing services for diagnostic partners globally.
- Ownership category
- akta.pro rank
Lumos Diagnostics industry classification
Industry- Product category
- Point-of-Care Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA)
- akta.pro secondary industries
- Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Clinical CROs (Phase I–IV) (HLAGAAAA)
Keywords
Where Lumos Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Carlsbad
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Lumos Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Supply Chain, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- FebriDx Product Sales: Direct product revenue from FebriDx sales through distribution partners in US, ANZ, and international markets. FebriDx product revenue doubled to USD 1.7 million in H1 FY26. Reimbursement secured at USD 41.38 per test from CMS.
- Contract Manufacturing Services: Lumos provides contract development and manufacturing services for diagnostic products including assay development, readers, manufacturing, medical affairs, and regulatory affairs support. Revenue from Micro-Pak Mold Analyzer manufacturing agreement (initial order US$250,000) and Aptatek PheCheck contract (US$400,000 follow-on contract, US$1.5 million original contract).
- Milestone Payments: Pre-payments and milestone payments from distribution partners (US$7.5 million total pre-payments from PHASE Scientific including US$5 million after CLIA waiver), BARDA funding (US$6.198 million committed for pediatric study), and regulatory milestone payments.
- Distribution Agreement Revenue: Six-year distribution agreement with PHASE Scientific valued at USD 317 million activates following CLIA waiver clearance, providing ongoing product order revenue.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | FebriDx test kit reimbursement rate |
Go-to-market motion2 records
Distribution channels6 records
Marketing channels5 records
Lumos Diagnostics product offering
Product offeringCore offering
Lumos Diagnostics develops, manufactures and distributes rapid point-of-care diagnostic test products, with its flagship FebriDx test using a fingerstick blood sample to differentiate bacterial from non-bacterial acute respiratory infections via dual biomarker (CRP + MxA) technology. The company also provides fee-based contract development, manufacturing, and support services for diagnostic products — including assay development, proprietary digital reader platforms, companion apps, and medical/quality/regulatory affairs — through its ISO 13485 certified Carlsbad, California facility.
Product overview
Lumos Diagnostics offers a portfolio of proprietary point-of-care diagnostic products and comprehensive contract development and manufacturing services. The core proprietary product is FebriDx, a rapid point-of-care test that differentiates bacterial from viral respiratory infections using dual biomarker technology. The company operates an ISO 13485 certified contract manufacturing and development services business supporting external partners, including assay development, reader platforms (disposable and reusable), app/cloud connectivity solutions, medical affairs, and quality/regulatory affairs services. Services are provided through a co-located manufacturing and R&D facility in Carlsbad, California. The company also has contract manufacturing agreements for products like the Micro-Pak Mold Analyzer and is developing the PheCheck PKU monitoring device with Aptatek Biosciences.
Differentiator
Problem solved
Functional benefit
Brands
- FebriDx: Rapid point-of-care test that uses a fingerstick blood sample to aid in the differentiation between bacterial infection and non-bacterial etiology
- Mold Analyzer
- PheCheck
Products and services
- FebriDx Rapid point-of-care test that uses a fingerstick blood sample to differentiate between bacterial infection and non-bacterial etiology in patients aged 12-64 presenting with acute respiratory infection symptoms. Uses proprietary dual biomarker technology combining CRP and MxA, delivers 99% NPV to rule out bacterial infection with results in 10 minutes. FDA 510(k) cleared with CLIA waiver. Sold to US urgent care and emergency care providers via distribution partners.
- Contract Manufacturing Services
Quantifiable outcome
- 99% NPV (Negative Predictive Value) for ruling out bacterial infection
- +7 more outcomes
Companies that use Lumos Diagnostics
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles4 records
Lumos Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Lumos Diagnostics partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered significant, core and supporting.
- Micro-PaksignificantThree-year contract manufacturing agreement for Mold Analyzer system, the world's first rapid test cassette to detect 56 mould species. Initial purchase order valued at US$250,000. Validates Lumos' services business by converting four years of contract development into commercial-scale manufacturing.
- PHASE ScientificcoreExclusive US distribution partner for FebriDx under USD 317 million, 6-year distribution agreement. PHASE Scientific has commercial infrastructure built out for broad deployment following FDA CLIA waiver clearance. Provided US$5 million milestone pre-payment and total pre-payments of US$7.5 million.
- Aptatek BiosciencessupportingFollow-on contract worth approximately US$400,000 to manage clinical study advancing PheCheck in-home PKU monitoring device toward FDA clearance. Six-month agreement on time-and-materials basis. Subject to FDA clearance, Lumos expects to pursue commercial manufacturing opportunities.
- AcuityMDsupportingStrategic collaboration to accelerate market access for FebriDx in US market.
- Amtech/YesGroupsupportingNew ANZ distribution agreement with Amtech, part of YesGroup alliance. YesGroup employs over 150 team members and offers more than 25,000 product lines across Australia and New Zealand.
- BARDA (Biomedical Advanced Research and Development Authority)coreUS government agency providing non-dilutive funding of up to US$6.198 million for FebriDx pediatric clinical study. Total milestone payments received to date of US$2.59 million. BARDA funding supports pediatric study across 20 US clinical sites enrolling 500-800 patients.
- PRO-spectussupportingUS-based market access consultancy providing strategic and operational services to accelerate patient access to FebriDx. Services include development of strategic collateral, dedicated helpline for coding/coverage inquiries, and field support team for provider adoption support. Program running through December 2026.
- MediGroupsupportingNational contract awarded for FebriDx diagnostic test products.
- Thermo Fisher ScientificsupportingAppointed as US distributor for FebriDx products.
- Henry ScheinsupportingExpanded distribution partnership for FebriDx in ANZ and US markets. Henry Schein serves as sub-distributor of Lumos' US commercial partner PHASE Scientific and expanded ANZ distribution.
- HologicsupportingDevelopment partnership with Hologic, one of the world's leading diagnostic companies. Lumos achieved first Phase 2 milestone in Hologic agreement.
- Atomo DiagnosticssupportingAtomo provides proprietary test cassettes to Lumos for the CLIA-waived FebriDx test as supply partner.
Scale indicators12 records
Recent moves6 records
Expansion highlights6 records
Lumos Diagnostics competitors and assessment
Company assessmentDirect peers
- QuidelOrtho: Direct competitor in rapid point-of-care infectious disease diagnostics (Sofia, Triage, QuickVue) sold into urgent care, primary care, and CLIA-waived settings — directly overlapping with FebriDx's positioning and customer base.
- Atomo Diagnostics: Direct peer and critical supplier to Lumos — designs integrated rapid diagnostic test devices (including the cassette platform used in the CLIA-waived FebriDx); competes in the same integrated POC device category while also being a key input supplier.
- Meridian Bioscience: Develops and manufactures lateral-flow and molecular diagnostic tests across infectious disease; comparable assay-development and contract-manufacturing capabilities to Lumos's Carlsbad services business and overlapping product portfolio.
- Sekisui Diagnostics: Provider of rapid immunoassay diagnostics (OSOM brand) and clinical chemistry reagents; directly comparable lateral-flow POCT portfolio targeting urgent care and physician office labs.
Broad incumbents
- Abbott Diagnostics: Incumbent in rapid diagnostics with BinaxNOW and ID NOW platforms widely deployed across US urgent care and retail clinics; comparable distribution scale and respiratory testing footprint to FebriDx but with a much broader menu and balance sheet.
- bioMérieux: Operator of the BioFire FilmArray respiratory panel — the dominant molecular alternative to rapid antigen/bacterial-vs-viral tests; targets overlapping urgent-care and hospital customers with higher-sensitivity molecular results competing for the same antibiotic-stewardship use cases.
- Becton Dickinson (BD): Sells the BD Veritor system for rapid immunoassay testing in point-of-care settings, directly comparable to Lumos's FebriDx instrument-free platform; broader portfolio and established distribution into US ambulatory care.
- Cepheid (Danaher): Markets the Xpert family of molecular point-of-care tests (including Xpress for CLIA-waived settings); competes with FebriDx for rapid respiratory infection workflows but at higher cost and complexity.
- Hologic: Major molecular diagnostics company and a current Lumos development partner; comparable respiratory and women's health diagnostics portfolio with established hospital sales channels overlapping FebriDx's target accounts.
Emerging players
- Response Biomedical: Develops rapid immunoassay tests (RAMP platform) for infectious disease and cardiovascular markers; smaller-scale direct competitor to FebriDx in POC immunoassay respiratory testing.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
Lumos Diagnostics social profiles
Digital presenceLumos Diagnostics compliance and trust
Trust signalCompliance1 record
Lumos Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Lumos Diagnostics leadership team
Management profileNumber of profiles
Profiles14 records
Lumos Diagnostics funding detail
Funding detailFunding overview
Funding rounds5 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Lumos Diagnostics M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Lumos Diagnostics
What does Lumos Diagnostics do?
Lumos Diagnostics develops, manufactures and distributes rapid point-of-care diagnostic test products, with its flagship FebriDx test using a fingerstick blood sample to differentiate bacterial from non-bacterial acute respiratory infections via dual biomarker (CRP + MxA) technology. The company also provides fee-based contract development, manufacturing, and support services for diagnostic products — including assay development, proprietary digital reader platforms, companion apps, and medical/quality/regulatory affairs — through its ISO 13485 certified Carlsbad, California facility.
Is Lumos Diagnostics a public or private company?
Lumos Diagnostics is a public company. It is classified as public and is currently operating.
When was Lumos Diagnostics founded?
Lumos Diagnostics was founded in 2019. It employs 101 to 250 people.
Where is Lumos Diagnostics based?
Lumos Diagnostics is headquartered in Carlsbad, United States, in the North America region.
How does Lumos Diagnostics make money?
Four revenue lines are on record. FebriDx Product Sales are the primary driver. The others are contract Manufacturing Services, milestone Payments and distribution Agreement Revenue.
Who are Lumos Diagnostics's main competitors?
Direct peers on record are QuidelOrtho, Atomo Diagnostics, Meridian Bioscience and Sekisui Diagnostics. Broad incumbents are Abbott Diagnostics, bioMérieux, Becton Dickinson (BD), Cepheid (Danaher) and Hologic. Response Biomedical is listed as an emerging player.
Does Lumos Diagnostics have an API?
No public API is recorded for Lumos Diagnostics.
What industry is Lumos Diagnostics in?
Lumos Diagnostics's product category is Point-of-Care Diagnostics. Its primary akta.pro industry code is HLAHAOAA, Infectious Disease POCT (Respiratory, STI, HIV, Sepsis), with a secondary code of HLAGAAAH, Pharmacovigilance, Risk Management & Medical Affairs CROs. Its NAICS code is 325413 and its SIC code is 2835.