Atomo Diagnostics gets green light on HIV test

Atomo Diagnostics has received a major boost to its global expansion plans for its HIV self-test.

John Kelly with an Atomo diagnostic kit that tests for blood diseases such as HIV. Picture: Hollie Adams.

Sydney medical device developer Atomo Diagnostics, which is backed by the Bill & Melinda Gates Foundation, has received a major boost to its global expansion plans for its HIV self-test.

The company will announce today that it has been confirmed as eligible for procurement by organisations entitled to access Global Fund and Unitaid resources. The Global Fund, which raises and invests $US4 billion ($5.3bn) annually to support its programs, works to end AIDS, tuberculosis and malaria, while Unitaid, which is backed by the World Health Organisation, works on preventing, diagnosing and treating those conditions.

Atomo’s HIV self-test device has been approved by the World Health Organisation’s expert review panel for diagnostics, a special process determined by Unitaid and the Global Fund to expedite access to innovative diagnostic products in advance of approvals through the WHO pre-qualification process.

John Kelly, chief executive of Atomo Diagnostics, which is also backed by former Macquarie head Allan Moss and property developer Lang Walker, said this move would enable expansion of HIV self-testing beyond the private sector and into the growing global health sector.

“We launched in the private sector in South Africa and Kenya earlier this year and in both of those markets we are the leading HIV self-test in the pharmacy private sector channel,” Mr Kelly said. “Next year we will be looking to talk to health departments in large countries, as well as large NGOs, about research pilots to start showing usability and acceptability of the product in those channels.”

Mr Kelly is backing the company’s outlook as he believes there will be a rapid transition to self-testing for HIV. Unitaid have estimated that in five years the market for self-testing in global health would be about 15-20 million tests annually, representing a $60 million-$70m market segment.

“We would be looking to establish ourselves as one of the two market leaders in that segment,” Mr Kelly said.

The HIV self test needs only a single drop of blood, obtained from the fingertip. When used by untrained users in the field, the test, which was designed and developed in Sydney, demonstrated 100 per cent concordance to laboratory results.

Atomo secured European approval for its HIV self test in October and is now in discussion with distribution partners.

“We are hopeful of being able to close out in the first quarter of next year a sizeable strategic partnership with a large listed company who want to take our HIV product exclusively across the global health markets,” Mr Kelly said.