Atomo Diagnostics’ CEO John Kelly announced today that the Atomo HIV Self Test has been granted CE Marking by a European Union Notified Body. The company 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.
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. It 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. Additionally, as a 3rd generation test, the Atomo HIV Self Test can detect HIV antibodies earlier than established 2nd generation competitor tests.
John Kelly, Chief Executive Officer of Atomo Diagnostics explains what this means for self-testers:
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.
Atomo Diagnostics also announced 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.