Atomo Diagnostics
Atomo Diagnostics is an ASX-listed Australian medical device company that designs and manufactures user-centred rapid diagnostic test platforms (AtomoRapid Pascal, Galileo, Elion, Curie, Florey) and finished blood-based tests, anchored by its WHO-prequalified HIV Self Test and serving consumer retail, OEM partners, and government and NGO public health programs across 40+ countries.
- Company typePrivate
- Founded2010
- HeadquartersLeichhardt, Australia
- Headcount11–50
- GTM typeB2B and B2C
- OfferingHardware or Manufacturing
What Atomo Diagnostics does
Atomo Diagnostics Limited is an Australian medical device company, founded in 2010 by John Kelly and headquartered in Leichhardt, NSW, that designs and manufactures user-centred rapid diagnostic test (RDT) platforms for point-of-care and self-test applications. The company's core technology integrates a safety lancet, blood-collection and delivery system, and proprietary buffer-delivery mechanism into all-in-one cassette devices to reduce user error and improve test accuracy. Its platform family comprises the AtomoRapid Pascal, Galileo, Elion, Curie and Florey devices, with the Galileo platform holding WHO Prequalification status and Pascal-derived products holding FDA 510(k) clearance and CE Mark certification. The company's flagship finished product is the Atomo HIV Self Test, launched in Australia in 2018 as the first integrated blood-based HIV self-test on the Australian Register of Therapeutic Goods (ARTG 311989), with 99.6% specificity and sensitivity and a 15-minute read time.
Atomo operates a multi-channel business model across four revenue streams. First, finished rapid diagnostic products are sold directly via the Atomo e-commerce store and through Australian pharmacy retail (including Blooms the Chemist, with pharmacist training required), UK retail (Boots, Tesco via Newfoundland Diagnostics), and consumer channels under own and partner brands. Second, OEM cassette supply provides proprietary cassettes to partners such as Lumos Diagnostics (for the FDA-cleared FebriDx respiratory test) and NG Biotech (for the IVDR-approved Precision+ blood pregnancy test). Third, technology licensing and co-development arrangements exist with BBI Solutions, DCN Diagnostics, and Palladium Diagnostics. Fourth, contract manufacturing services are delivered from the Cape Town facility, which is ISO 13485:2016 certified, currently operating at up to 3 million units per year with expansion capability to more than 10 million units per year.
The company serves four primary segments: sexual health and infectious disease testing (HIV, syphilis, respiratory), consumer self-testing, professional point-of-care healthcare settings, and public health programs. The latter channel is anchored by government- and NGO-run vending machine programs (NSW Ministry of Health MyTest, SAMESH Connect, Queensland Positive People Rapid, NAPWHA free-test distribution) and by the Viatris (Mylan) distribution partnership into lower-middle-income markets in Africa, South and Central America, and Asia. Atomo cites regulatory clearance across 40+ countries, cumulative shipments of over 7 million platforms, and a manufacturing footprint configured to serve the PEPFAR goal of 15 million HIV tests sourced from African manufacturers by 2025. The company is publicly listed on the ASX under the ticker AT1 with 11-50 employees.
Atomo Diagnostics firmographics
Firmographics- Name
- Atomo Diagnostics
- Legal name
- Atomo Diagnostics Limited
- Website
- https://atomodiagnostics.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Atomo Diagnostics is an ASX-listed Australian medical device company that designs and manufactures user-centred rapid diagnostic test platforms (AtomoRapid Pascal, Galileo, Elion, Curie, Florey) and finished blood-based tests, anchored by its WHO-prequalified HIV Self Test and serving consumer retail, OEM partners, and government and NGO public health programs across 40+ countries.
- Ownership category
- akta.pro rank
Atomo Diagnostics industry classification
Industry- Product category
- In-Vitro Diagnostic Devices
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Infectious Disease & STI Testing-to-Treatment with eRx + Pharmacy Fulfillment (HLALAIAL)
Keywords
Where Atomo Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Leichhardt
- HQ country
- Australia
- HQ region
- Oceania
Offices2 records
Markets served
Atomo Diagnostics business model
Business model- GTM type
- B2B and B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Operations, Supply Chain, Personnel, Marketing or Sales
Revenue model
- Rapid Diagnostic Test Device Sales: Sale of finished rapid diagnostic test products marketed under Atomo's own brand (HIV Self Test) or through private labels via partners and regional distributors.
- OEM Cassette Supply: Supply of proprietary diagnostic cassettes to OEM partners (Lumos Diagnostics for FebriDx, NG Biotech for Precision+ pregnancy test) who incorporate them into their own branded products.
- Technology Licensing and Co-Development: Partnership arrangements including co-development, technology licensing, and custom design solutions for assay developers. Partners include BBI Solutions, DCN Diagnostics, and Palladium Diagnostics.
- Contract Manufacturing: Manufacturing services at Cape Town facility with capacity up to 3 million units, expandable to 10 million units per year. Includes assay manufacturing, buffer production, and secondary packaging.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Atomo HIV Self Test consumer retail price |
Go-to-market motion2 records
Distribution channels6 records
Marketing channels5 records
Atomo Diagnostics product offering
Product offeringCore offering
Atomo Diagnostics designs, develops, and manufactures integrated, user-centred rapid diagnostic test (RDT) platforms and finished diagnostic products for point-of-care and consumer self-testing applications. Its AtomoRapid™ platform family integrates safety lancets, blood/swab collection, and patented buffer-delivery systems into all-in-one cassettes that reduce user error. The company sells its own Atomo HIV Self Test through e-commerce and pharmacies, supplies proprietary cassettes to OEM partners (Lumos Diagnostics, NG Biotech), and offers co-development, licensing, and contract manufacturing services from its ISO 13485-certified Cape Town facility.
Product overview
Atomo Diagnostics offers a portfolio of rapid diagnostic test platforms and finished products designed for point-of-care and self-testing applications. The AtomoRapid™ platform family includes five distinct devices: Pascal (blood-based with integrated buffer delivery), Curie (swab-based), Galileo (enhanced blood platform with WHO prequalification), Elion (self-test focused), and Florey (modular add-on for existing cassettes). These platforms are differentiated by their integrated components, interlocked user steps, and proprietary blister technology that eliminate common user errors. Finished products commercialized under Atomo's brand or through partners include the Atomo HIV Self Test (99.6% accuracy, 15-minute results), NG Biotech Precision+ Pregnancy Test (IVDR-approved), and Lumos Diagnostics FebriDx (FDA-cleared for respiratory infection differentiation). The company also provides digital health solutions including a mobile application with cloud connectivity and camera-based reader technology for quantitative test analysis.
Differentiator
Problem solved
Functional benefit
Products and services
- AtomoRapid™ Pascal Rapid diagnostic test platform with built-in safety lancet, blood collection and delivery system, and integrated buffer delivery mechanism. Interlocked user steps mitigate common user errors. Designed for point-of-care and self-test applications, and supplied to OEM partners such as Lumos Diagnostics (FebriDx) and NG Biotech (Precision+).
- AtomoRapid™ Curie Swab-based testing platform that expands Atomo's range beyond blood-based diagnostics. Consolidates components, integrates blister and lyophilised buffer reagent, and removes the need for manual sample dosing, reducing user steps and improving sample concentration.
- AtomoRapid™ Galileo Rapid diagnostic test platform with integrated safety lancet and unique blood collection and delivery system. WHO prequalified. Improves test performance and usability with interlocked user steps for professional point-of-care and self-test applications.
- AtomoRapid™ Elion Self-test focused platform with built-in safety lancet, innovative blood collection feature, single-action blood and buffer delivery system, and interlocked user steps. Designed specifically for self-test users with focus on unmatched usability.
- AtomoRapid™ Florey Modular blood-based usability upgrade for existing standard lateral flow cassettes. Clips onto existing cassettes providing integrated blood and reagent buffer delivery, improving usability and precision while maintaining compatibility with existing installed manufacturing capacity and regulatory approvals.
- Atomo HIV Self Test World's first integrated, blood-based rapid diagnostic test for HIV screening. Delivers results in 15 minutes with 99.6% specificity and sensitivity. Listed on the Australian Register of Therapeutic Goods (ARTG 311989) since 2018. Sold directly to consumers via e-commerce (atomohivtest.com), through Australian pharmacies with required pharmacist training, and via distribution partners in the UK and lower-middle income markets.
- NG Biotech Precision+ Pregnancy Test Partner-branded finished product that uses Atomo's Pascal platform as its cassette. First all-in-one at-home blood pregnancy test, IVDR-approved and available across Europe. Results in 5 minutes with higher accuracy than urine-based pregnancy tests. Atomo supplies the proprietary cassette to NG Biotech under an OEM partnership.
- Lumos Diagnostics FebriDx Partner-branded finished product that uses Atomo's Pascal platform as its cassette. Rapid test for identifying and differentiating viral and bacterial acute respiratory infections. FDA cleared (US) and CE marked (Europe) with 99% accuracy; demonstrated 80% reduction in antibiotic prescriptions in clinical use.
- Atomo App (Self-Test Mobile Application) Custom mobile application for self-test users providing multimedia-based instructions that optimises usability. Interfaces with an AWS portal for oversight and deployment management. Compatible with generic rectangular cassettes or AtomoRapid whole blood cassettes.
- Camera-Based Reader Technology Whole-blood cassettes compatible with various readers maximising ease of use, repeatability and accuracy of results for both colormetric and fluorescence-based testing. Features Bluetooth connectivity, WiFi HL7 interface for LIS communication, and cell phone data transport to cloud.
Quantifiable outcome
- 90% reduction in blood delivery errors compared to traditional lateral flow test kits
- +7 more outcomes
Companies that use Atomo Diagnostics
Customer profileNamed customers10 records
Segments5 records
Ideal customer profiles4 records
Atomo Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration4 records
Feature8 records
Atomo Diagnostics partnerships and signals
Strategic signalPartnerships
15 partnerships are on record, tiered core, secondary and strategic.
- Lumos DiagnosticscoreLumos Diagnostics utilises Atomo's Pascal platform for their FebriDx test, which is FDA-cleared for the US market and CE marked for Europe. FebriDx assists in identifying and differentiating viral and bacterial acute respiratory infections with 99% accuracy, reducing antibiotic prescriptions by 80%.
- NG BiotechcoreNG Biotech utilises Atomo's Pascal platform for their Precision+ pregnancy test, available throughout Europe. The blood-based test offers results in 5 minutes with higher accuracy than urine tests.
- Newfoundland DiagnosticscoreUK provider of diagnostic tests marketing Atomo's HIV Self Test under their own brand throughout the UK, Western Europe, and Colombia using the Galileo platform.
- Viatris (Mylan)coreViatris markets the Mylan HIV Self Test manufactured by Atomo across lower-middle income markets in Africa, South and Central America, and Asia. Distributed from South Africa to Lesotho, Namibia, Botswana, Zimbabwe, Zambia, Nigeria, Kenya, and Uganda.
- BBI SolutionssecondaryCDMO partner offering custom antibody development, lateral flow assay development and manufacturing services. Incorporating Atomo platforms into new development projects provides customers with simplified testing workflow and improved product usability.
- DCN DiagnosticssecondaryGlobal leader in IVD CDMO and CRO services based in Carlsbad, California. Specialises in tailored assay devices and lateral flow readers, supporting programs from concept to assay development and platform integration through clinical trials to manufacturing.
- Palladium DiagnosticssecondaryAssists developers and manufacturers of rapid point-of-care diagnostic devices in bringing technologies to marketplace efficiently and effectively. Participates in next generation rapid diagnostics development.
- Burnet InstitutestrategicCollaboration on development of a pioneering rapid active syphilis test using Atomo's Pascal platform with a unique syphilis antibody assay. The test will distinguish active infections from previously treated cases - a first for the global market. Part of $2.44M CRC-P grant project.
- IDE GroupstrategicCollaborating partner in the $2.44M CRC-P grant project for development of rapid active syphilis test with Atomo and Burnet Institute.
- NAPWHAcoreNational Association of People with HIV Australia provides free HIV self-tests through hivtest.au website. Purchases tests from Atomo using government funding, offering two free tests initially and two more after six months to encourage ongoing monitoring.
- GrindrstrategicSocial networking platform for LGBT+ community promoting NAPWHA's free HIV self-test initiative at no cost. Amplified visibility and awareness of testing availability across LGBT+ community.
- SAMESHsecondarySouth Australian organisation running Connect Program vending machines providing free HIV self-testing kits in discreet, accessible locations including universities and sex-on-premises sites.
- Queensland Positive PeoplesecondaryQueensland organisation running Rapid Program vending machines for HIV self-testing distribution across Queensland.
- NSW Ministry of HealthcoreGovernment body funding and implementing MyTest program - vending machines for HIV self-testing across NSW, Australia. Targeting MSM community and migrant populations.
- Thorne Harbour HealthstrategicVictorian health organisation planning nationwide expansion of HIV self-testing vending machine program to all Australian states and territories.
Scale indicators14 records
Recent moves6 records
Expansion highlights7 records
Atomo Diagnostics competitors and assessment
Company assessmentDirect peers
- OraSure Technologies: US-listed developer of rapid diagnostic tests including the OraQuick HIV self-test. Directly comparable as an HIV/sexual-health-focused rapid diagnostics specialist with self-test and professional POC channels across global public health and retail markets.
- Lumos Diagnostics: Point-of-care diagnostics company whose FebriDx product is built on Atomo's Pascal platform. Competes in rapid infectious-disease and respiratory testing with FDA-cleared products and overlapping professional POC and hospital customers.
- Chembio Diagnostics: Specialty rapid diagnostics developer focused on infectious disease (HIV, syphilis, dengue) point-of-care tests. Highly comparable as a small-cap, HIV/sexual-health-focused rapid test company serving public health and professional POC markets.
- NG Biotech: French in-vitro diagnostics company that OEM-integrates Atomo's Pascal platform for the IVDR-approved Precision+ blood pregnancy test. Overlaps in blood-based rapid test development, self-test regulatory pathways, and European distribution.
- Trinity Biotech: Public diagnostics company with a portfolio that includes rapid HIV tests and other point-of-care infectious disease assays. Comparable as a small-to-mid-cap rapid diagnostics company with overlapping public health and clinical lab customers.
Broad incumbents
- Abbott (Rapid Diagnostics / BinaxNOW): Global IVD incumbent with BinaxNOW and other lateral-flow rapid tests sold through retail pharmacy, professional POC, and OEM channels. Competes in the same integrated, user-friendly rapid test category that Atomo serves, but with vastly greater scale and distribution.
- QuidelOrtho: Large IVD company with Sofia and Triage rapid diagnostic platforms sold to professional POC, hospital, and retail channels. Comparable in rapid lateral-flow assay development, regulatory depth, and assay-portfolio extensibility.
- Roche Diagnostics: Global IVD leader with broad rapid test, self-test, and digital health offerings. Relevant as a large incumbent competing in integrated user-friendly rapid diagnostics and as a potential strategic acquirer of niche self-test platform companies like Atomo.
Emerging players
- BBI Solutions: Global lateral flow CDMO and reagent provider offering custom assay development and OEM cassette manufacturing. Comparable as a partner and competitor in OEM-supply relationships for rapid test developers seeking integrated cassette platforms.
- DCN Diagnostics: Carlsbad-based IVD CDMO/CRO specialising in tailored lateral flow assay devices and readers, from concept through manufacturing. Comparable as a co-development partner and competitor in the custom integrated rapid test platform space.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Atomo Diagnostics social profiles
Digital presenceAtomo Diagnostics compliance and trust
Trust signalCompliance6 records
Atomo Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Atomo Diagnostics leadership team
Management profileNumber of profiles
Profiles5 records
Atomo Diagnostics funding detail
Funding detailFunding overview
Funding rounds7 records
Investors6 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Atomo Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Atomo Diagnostics
What does Atomo Diagnostics do?
Atomo Diagnostics designs, develops, and manufactures integrated, user-centred rapid diagnostic test (RDT) platforms and finished diagnostic products for point-of-care and consumer self-testing applications. Its AtomoRapid™ platform family integrates safety lancets, blood/swab collection, and patented buffer-delivery systems into all-in-one cassettes that reduce user error. The company sells its own Atomo HIV Self Test through e-commerce and pharmacies, supplies proprietary cassettes to OEM partners (Lumos Diagnostics, NG Biotech), and offers co-development, licensing, and contract manufacturing services from its ISO 13485-certified Cape Town facility.
Is Atomo Diagnostics a public or private company?
Atomo Diagnostics is a private company. It is classified as public and is currently operating.
When was Atomo Diagnostics founded?
Atomo Diagnostics was founded in 2010. It employs 11 to 50 people.
Where is Atomo Diagnostics based?
Atomo Diagnostics is headquartered in Leichhardt, Australia, in the Oceania region.
How does Atomo Diagnostics make money?
Four revenue lines are on record. Rapid Diagnostic Test Device Sales are the primary driver. The others are OEM Cassette Supply, technology Licensing and Co-Development and contract Manufacturing.
Who are Atomo Diagnostics's main competitors?
Direct peers on record are OraSure Technologies, Lumos Diagnostics, Chembio Diagnostics, NG Biotech and Trinity Biotech. Broad incumbents are Abbott (Rapid Diagnostics / BinaxNOW), QuidelOrtho and Roche Diagnostics. Emerging players are BBI Solutions and DCN Diagnostics.
Does Atomo Diagnostics have an API?
No public API is recorded for Atomo Diagnostics.
What industry is Atomo Diagnostics in?
Atomo Diagnostics's product category is In-Vitro Diagnostic Devices. Its primary akta.pro industry code is HLALAIAL, Infectious Disease & STI Testing-to-Treatment with eRx + Pharmacy Fulfillment. Its NAICS code is 325413 and its SIC code is 2835.