Atomo Diagnostics Receives CE Mark Approval for Both HIV Self-Test & HIV Professional Products

KEY TAKEAWAYS:

• CE Marking granted for Atomo HIV Self Test and AtomoRapid HIV for professional use
• Approval from the World Health Organisation’s Expert Review Panel for Diagnostics for Atomo HIV Self Test
• Atomo HIV Self Test received approval from Kenya Ministry of Health
• AtomoRapid HIV received approval from Nigerian Ministry of Health
• Two OEM agreements signed for the licencing and sale of Atomo’s device technology
• Grand Challenges Canada invested US$1 million
• Doris-Ann Williams MBE, CEO of the British IVD Association, joined the Board of Atomo

Atomo Diagnostics is a world leader in the device, design, development and commercialisation of innovative, user-friendly, rapid test products. The recipient of multiple international awards for innovation and design, Atomo’s all-in-one AtomoRapid™ handheld device platforms make it easy to test and screen for a range of infectious diseases and chronic conditions. Unlike standard, multi-component rapid test kits, AtomoRapid™ platforms integrate features and functionality.

The company has also attracted grant funding from Commercialisation Australia, the NSW Medical Devices Fund, Austrade and the Bill and Melinda Gates Foundation, as well as securing significant financial support from the Global Health Investment Fund.

During 2017, Atomo Diagnostics was granted CE Marking for both its HIV Self Test and HIV professional use products. Atomo is now finalising a number of strategic commercialisation agreements with key partners to launch these products across global markets in 2018.

The Atomo HIV Self Test has also received approval from the World Health Organisation’s Expert Review Panel for Diagnostics (ERP-D). This allows the product to be procured by organisations eligible for Global Fund and UNITAID funding. There are currently more than 50 million HIV rapid tests procured annually using Global Fund and UNITAID funds.

In addition to growing sales channels for Atomo’s own range of commercial products, the company also provides its award-winning products as an OEM offering for other diagnostic companies looking to improve their product offerings or enter self-test markets. In 2017, two major OEM agreements were completed with global partners for the licensing and distribution of products with several more agreements anticipated for completion during 2018.

About Atomo Diagnostics

Atomo Diagnostics is a multi-award winning and rapidly growing medical device company that has developed and commercialised AtomoRapid™, the world’s first integrated device for blood based immunoassay rapid diagnostic testing (RDTs) in point of care settings.

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