CE Marking for World’s Only Integrated HIV Self-Test from Atomo Diagnostics Gives Access to Safe, Accurate and Reliable Self-Testing - European Medical Journal

CE Marking for World’s Only Integrated HIV Self-Test from Atomo Diagnostics Gives Access to Safe, Accurate and Reliable Self-Testing

3 Mins
  • Atomo HIV Self Test granted CE Mark; will facilitate rollout in European and other global markets
  • Test will be available commercially during 2018 via retail, e-commerce and public health channels
  • Simple, safe, accurate results from a single drop of blood in minutes
  • 3rd generation test detects HIV antibodies earlier than 2nd generation competitor tests

Sydney, Australia, 10 October, 2017 – Atomo Diagnostics, a world leader in innovative point-of-care, rapid diagnostic devices, announced today that its Atomo HIV Self Test has been granted CE Marking by a European Union Notified Body.

The Atomo HIV Self Test is the world’s only integrated self-test device, providing greater convenience, ease-of-use and infield diagnostic performance when compared to other multi-component HIV test kits. Atomo Diagnostics is now actively engaging with commercialisation and distribution partners to make the test widely available in European and other global markets during 2018 via retail, e-commerce and public health channels.

Designed as an at-home self-test, the Atomo HIV Self Test is a rapid, lateral flow in vitroqualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 in human whole blood.

The Atomo HIV Self Test needs only a single drop of blood, obtained from the fingertip using the built-in safety lancet.  The test device also incorporates a unique blood collection and delivery system to further simplify the test procedure and eliminate user errors common to other test kits. An accurate result is provided in minutes.

When used by untrained users in the field, the Atomo HIV Self Test demonstrated 100% concordance to laboratory results in independent studies, making it the best performing self-test approved to date. Additionally, as a 3rd generation test, the Atomo HIV Self Test can detect HIV antibodies earlier than established 2nd generation competitor tests.

“Self-testing is facilitating greater access to HIV testing for previously hard-to-reach and high-burden groups.  Studies have also shown that our test has a high degree of acceptance and take-up amongst the young, which could be central to stemming infection rates and increasing access to treatment,” said John Kelly, Chief Executive Officer of Atomo Diagnostics. “CE Marking means that the Atomo HIV Self Test can now be made available to anyone who wants a safe, convenient, accurate and private way to find out their HIV status in minutes,” he added.

HIV self-testing is increasingly seen as vital if the global health community is to achieve the goals of the 90-90-90 initiative of the Joint United Nations Programme on HIV/AIDS (UNAIDS).  The aim of the initiative is to ensure that by 2020 90% of those living with HIV will know their status, 90% of those individuals will be on antiretroviral therapy (ART), and 90% of individuals on ART will be virologically suppressed. To achieve even the first 90% is a major undertaking: UNAIDS estimates that, as of July 2017, only 70% of the 36.7 million people living with HIV knew their status.

“HIV self-testing has the potential to be a game-changer in achieving the UNAIDS ambitious goal of 90% of all HIV positive people knowing their status by 2020,” said Linda-Gail Bekker, President of the International AIDS Society, and a member of Atomo’s Clinical Advisory Board.

Atomo is proud to be playing its part in helping to achieve the first 90-90-90 milestone, also announcing today that it has obtained CE approval for the 3rd generation version of its established professional use rapid diagnostic test, AtomoRapid HIV (1&2).  Approval of this more sensitive 3rd generation test will further support early detection of HIV infections and facilitate more effective interventions.

Link to the press release

About Atomo Diagnostics
Atomo Diagnostics is a medical device company, based in Sydney, Australia, with corporate offices in the UK and South Africa. The company specialises in the design, development and commercialisation of innovative rapid diagnostic test (RDT) solutions for use with capillary blood samples, including the Atomo HIV Self Test and AtomoRapid HIV (1&2) professional use RDT.

Atomo’s refreshing, user-centered approach to design and willingness to reimagine what has gone before has led it to create products that are simpler to use and that help prevent common user errors associated with standard RDT kits.  The recipient of multiple international awards for design and innovation, Atomo’s all-in-one platform devices put the end user first and make it easy to test and screen for a range of infectious diseases and chronic conditions.

As well as commercialising products in its own brand and working with distribution partners internationally, Atomo provides OEM product development services to specialist diagnostic companies worldwide.

About the Atomo HIV Self Test
Designed specifically for ease-of-use in the hands of lay users, the integrated Atomo HIV Self Test consists of a 3rd generation HIV test strip in a handheld device that incorporates a sterile safety lancet and unique blood collection and delivery system. The test is performed by delivering a small drop of capillary blood from a finger prick onto the test strip, and then applying drops of chase buffer (diluent). Within 15 minutes a control line will become visible on the test strip to indicate that the test has worked.  A second line – the test line – will only become visible if the applied sample contained antibodies to HIV.

For more features and benefits download the Product Brochure >

Media Contacts
Atomo Diagnostics
John Kelly
Email: [email protected]
Tel: +61 (0)2 9099 4750

Instinctif Partners
Sue Charles / Gemma Harris
Email: [email protected]
Tel: +44 (0) 207 7866 7860

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