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Atomo Diagnostics, Viatris Ink Deal With Unitaid to Expand HIV Self-Test Access

NEW YORK – Atomo Diagnostics and Viatris announced on Thursday that they have signed a multiyear agreement with global health agency Unitaid to expand access to HIV self-testing in low- and middle-income countries.

The deal is part of a Unitaid access expansion program that also involves other self-test makers.

Unitaid will support the supply of as many as 1 million HIV self-tests to 135 eligible LMICs, according to a statement from Atomo and Viatris, with the access expansion program expected to stimulate additional in-country demand for self-testing.

In a separate statement issued on Wednesday, Unitaid noted that the self-test market has been "dominated by a single, affordable test," but that the new expansion program and contract with Viatris will cut the cost per test in half, reducing it to less than $2 per test.

The nonprofit also said that a recently developed blood-based HIV self-test from Abbott is currently undergoing regulatory review and will also form the basis of the access expansion program.

"HIV self-testing is a crucial factor in helping people learn their status — it is one of the key ways in which the global goals for HIV will be achieved," said Robert Matiru, Unitaid director of programs, in a statement. The new access program "will have a concrete impact on the ability of countries to access affordable self-testing, a foundation of people-centered healthcare in which Unitaid has led the way," he added.

Based in Sydney, Atomo designs and manufactures HIV-self tests as well as tests for other infectious diseases. Viatris, a Pittsburgh-based firm, distributes the tests globally through its Mylan subsidiary in LMICs.

The Mylan HIV self-test, which is prequalified by the World Health Organization, detects antibodies against HIV in fingerstick blood samples. It also uses an integrated, handheld device called AtomoRapid that can reduce user errors, the firms said.

According to the firms, WHO has estimated the global health HIV self-testing market to be 11 million tests in 2021, increasing to 29 million tests by 2025.

The announcement "signifies a material step-up in demand for HIV self-tests globally," said John Kelly, Atomo's cofounder and managing director. "This demand enables Atomo to achieve sustainable operational and supply chain efficiencies, allowing us to support Viatris in its discussions with Unitaid," he said.

Atomo has opened a new facility in South Africa dedicated to manufacturing HIV products for LMIC tender contracts as well as supplying the firm's existing HIV business in Australia and Europe. The facility was certified by international regulators, including the WHO, in late 2020, the firms said.