Expert Review Panel for Diagnostics Approves Atomo HIV Self Test for Procurement by Unitaid and the Global Fund

• Atomo HIV Self Test confirmed as eligible for procurement with Global Fund resources
• The approved product is a rapid, lateral flow in vitro qualitative immunoassay for the detection of antibodies to HIV Type 1 & Type 2 in human whole blood.
• Designed specifically for home use, this easy-to-use rapid HIV test gives an accurate result in minutes from a single drop of blood.
• Detects HIV antibodies earlier than 2nd generation competitor tests.

Sydney, Australia, 7 December 2017 - Atomo Diagnostics, the world leader in integrated point-of-care rapid diagnostic devices, announced today that its Atomo HIV Self Test has been confirmed as eligible for procurement by organisations entitled to access Global Fund and Unitaid resources.

The world’s only integrated HIV self-test device, the Atomo HIV Self Test has been approved by the World Health Organisation’s Expert Review Panel for Diagnostics (ERP-D), a special process determined by Unitaid and the Global Fund to expedite access to innovative diagnostic products in advance of approvals through the WHO prequalification process.

Recognised by the expert panel as an innovative diagnostic product, the Atomo HIV Self Test can now be procured by organisations accessing Global Fund and/or Unitaid funding for HIV self-test pilot programs which empower individuals to take control of their own health.

Following on from its recent CE Mark approval, which enables Atomo to market the product in Europe, the ERP-D approval will facilitate further expansion and commercial roll-out of the product in low- and middle-income countries (LMICs).

“We are delighted that the Expert Review Panel for Diagnostics has included the Atomo HIV Self Test on the Global Fund procurement list,” said John Kelly, Founder and Chief Executive Officer of Atomo Diagnostics. “This will enable further expansion of HIV self-testing beyond the private sector and into the growing global health sector, and will support programs aimed at ensuring early diagnosis of HIV.”

Designed to be used at home, the test provides improved in-field diagnostic performance when compared to other multi-component HIV test kits. When used by untrained self-test 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.