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Atomo Diagnostics Wins Australian Approval for HIV Self-Test

NEW YORK (360Dx) — Atomo Diagnostics announced recently that it has received approval for its HIV self test from Australia's Therapeutic Goods Administration.

The Atomo Self Test is a lateral flow, in vitro qualitative immunoassay that detects human antibodies to HIV virus type 1 and type 2 in whole blood. It was designed for use by non-experts, including general consumers. A handheld device comprising a sterile safety lancet, patented blood collection and a delivery system, the test requires one finger prick of blood and can provide results within 15 minutes, Atomo said.

The test — which received CE marking in late 2017 — is the first HIV self test approved in Australia, according to Sydney-based Atomo.

Earlier this year, Atomo licensed the exclusive European rights to the HIV test to Owen Mumford. It also recently licensed the test's exclusive commercial rights in more than 100 countries in Africa, Asia, the Middle East, the Commonwealth of Independent States, and Latin America to Mylan Pharmaceuticals.