World’s only Atomo HIV Self Test receives CE Marking from European Union Notified Body

Oct 12 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 commercialization 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 vitro qualitative 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 3^rd generation test, the Atomo HIV Self Test can detect HIV antibodies earlier than established 2^nd 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 Program 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 3^rd generation version of its established professional use rapid diagnostic test, AtomoRapid HIV (1&2). Approval of this more sensitive 3^rd generation test will further support early detection of HIV infections and facilitate more effective interventions.

Source: http://atomodiagnostics.com/press-release-ce-marking-worlds-integrated-hiv-self-test-atomo-diagnostics-gives-access-safe-accurate-reliable-self-testing/