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Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test

NEW YORK – Mylan and Atomo Diagnostics today announced that the World Health Organization has granted prequalification approval for the Mylan HIV Self Test, a handheld lateral flow immunoassay self-test, enabling testing in the home and targeting hard-to-reach populations.

Using a fingerstick, the Mylan HIV Self Test detects whether HIV antibodies are present in about 15 minutes, the firms said.

WHO prequalification signifies that the product meets global standards of quality, safety, and performance and is a signal to global funders and ministries of health that the product can be procured.

Linda-Gail Bekker, executive director of the Desmond Tutu HIV Foundation, said in a statement that "having more high-quality and user-friendly HIV self-tests on the market, like the Mylan HIV Self Test … will give us a powerful tool in expanding diagnosis and treatment of vulnerable and previously untested populations."

In September 2018, Canonsburg, Pennsylvania-based Mylan announced a partnership with Sydney-based Atomo Diagnostics, the test manufacturer, covering more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States, and Latin America. Under the terms of the deal, Mylan — which markets a number of HIV drugs and combination therapies — has the exclusive rights to commercialize the tests.