Atomo Diagnostics
Atomo Diagnostics is a global leader in the user-centered design of innovative, accurate, and reliable rapid diagnostics. The company focuses on improving rapid diagnostic testing by elevating ease-of-use and performance, delivering lab-level performance at the point-of-care. They develop and commercialize rapid diagnostic test platforms, including blood-based and saliva testing solutions, with a strong emphasis on user experience, reducing errors, and enhancing healthcare outcomes. Atomo's platforms are approved in over 40 countries and hold regulatory approvals such as FDA, CE Mark, Australian TGA, and WHO prequalification. The company also offers development services, manufacturing capabilities, and digital health solutions, aiming to transform diagnostics through innovative, user-friendly products.
Industries
Nr. of Employees
small (1-50)
Atomo Diagnostics
Level 1, 3-5 George Street, Leichhardt, NSW, 2040, Australia
Patents
Products
Integrated blood-based self-test device (single-use)
Single-use, all-in-one lateral flow device combining an integrated safety lancet, blood collection unit and metered buffer delivery designed for untrained users to screen for antibodies with a rapid result.
Integrated swab-based extraction and delivery device
Device that consolidates swab extraction, lyophilised or blistered buffer mixing and automatic delivery to a standard IVD cassette to remove manual dosing and improve sample transfer efficiency for swab diagnostics.
All-in-one professional point-of-care cassette platforms
Handheld and cassette-based platforms designed for professional settings that integrate lancet, controlled blood delivery and interlocked steps, adaptable to many lateral flow strips used in clinical and decentralized testing.
Integrated blood-based self-test device (single-use)
Single-use, all-in-one lateral flow device combining an integrated safety lancet, blood collection unit and metered buffer delivery designed for untrained users to screen for antibodies with a rapid result.
Integrated swab-based extraction and delivery device
Device that consolidates swab extraction, lyophilised or blistered buffer mixing and automatic delivery to a standard IVD cassette to remove manual dosing and improve sample transfer efficiency for swab diagnostics.
All-in-one professional point-of-care cassette platforms
Handheld and cassette-based platforms designed for professional settings that integrate lancet, controlled blood delivery and interlocked steps, adaptable to many lateral flow strips used in clinical and decentralized testing.
Services
End-to-end device development from user-centred design through prototype evaluation and verification, including optimisation of sample collection, reagent delivery, sequenced user workflows and cassette integration.
Manufacture of lateral flow test strips, assay reagents, blister filling and secondary packaging with batch release testing, validated processes and regulatory support for finished goods supplied under partner brands or distribution agreements.
Design and integration of mobile applications, camera-based readers, cloud portals and connectivity options to enable quantitative result capture, result transmission and remote deployment management.
Consultative and operational support for device registration, quality management system implementation, audit readiness, and preparation of regulatory submissions and technical documentation.
Training modules and certification processes for retail stockists to support regulated sale of self-tests, delivered via remote video and assessment.
End-to-end device development from user-centred design through prototype evaluation and verification, including optimisation of sample collection, reagent delivery, sequenced user workflows and cassette integration.
Manufacture of lateral flow test strips, assay reagents, blister filling and secondary packaging with batch release testing, validated processes and regulatory support for finished goods supplied under partner brands or distribution agreements.
Design and integration of mobile applications, camera-based readers, cloud portals and connectivity options to enable quantitative result capture, result transmission and remote deployment management.
Consultative and operational support for device registration, quality management system implementation, audit readiness, and preparation of regulatory submissions and technical documentation.
Training modules and certification processes for retail stockists to support regulated sale of self-tests, delivered via remote video and assessment.
Expertise Areas
- User-centred diagnostics design and human factors
- Point-of-care and at-home lateral flow diagnostics
- Rapid diagnostic product development and commercialization
- Lateral flow manufacturing and scale-up
Key Technologies
- Lateral flow immunoassay platforms
- Integrated safety lancet and capillary blood collection units
- Metered blister buffer delivery systems
- Integrated swab extraction and delivery mechanisms
News & Updates
An extensive survey conducted in 2023 comparing Atomo's Pascal Platform with traditional test kits, showing a strong user preference for Pascal due to performance and ease of use.
Atomo's manufacturing facility in South Africa supports up to 3 million units annually, with plans to expand to over 10 million units, supporting local jobs and supply chain in Africa.
An overview of Atomo's innovative approach to rapid diagnostics, emphasizing user-centered design, ease of use, and performance.
Multiple International Design Awards
Atomo has received several international design awards for its innovative diagnostic devices.
Regulatory Approvals in Over 40 Countries
Atomo's platforms are approved by FDA, CE, TGA, and WHO prequalification, demonstrating global recognition.
An extensive survey conducted in 2023 comparing Atomo's Pascal Platform with traditional test kits, showing a strong user preference for Pascal due to performance and ease of use.
Atomo's manufacturing facility in South Africa supports up to 3 million units annually, with plans to expand to over 10 million units, supporting local jobs and supply chain in Africa.
An overview of Atomo's innovative approach to rapid diagnostics, emphasizing user-centered design, ease of use, and performance.
Multiple International Design Awards
Atomo has received several international design awards for its innovative diagnostic devices.
Regulatory Approvals in Over 40 Countries
Atomo's platforms are approved by FDA, CE, TGA, and WHO prequalification, demonstrating global recognition.