Mylan, Atomo Announce WHO Prequalification Approval for HIV Self Test

Mylan and medical device manufacturer Atomo Diagnostics announced the Mylan HIV Self Test, a handheld in vitro HIV rapid diagnostic test for self-testing, has received Prequalification approval by the World Health Organization (WHO PQ).

The WHO PQ process includes a rigorous evaluation of the test's technical performance and manufacturing sites. 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. The Mylan HIV Self Test detects the presence or absence of HIV antibodies through a fingerstick. It uses one-fifth the volume of blood necessary for other tests and provides a result in just 15 minutes.

"HIV self-testing can be a game-changer in helping us meet the ambitious UNAIDS 90-90-90 targets, which require that 90% of all HIV positive people know their status by 2020. Having more high-quality and user-friendly HIV self-tests on the market, like the Mylan HIV Self Test that has been Prequalified by the World Health Organization, will give us a powerful tool in expanding diagnosis and treatment of vulnerable and previously untested populations," Linda-Gail Bekker, Executive Director of the Desmond Tutu HIV Foundation and a former president of the International AIDS Society, said.

The convenience and discretion afforded by self-testing enables individuals to test in the comfort and privacy of their own home, making the test an effective way of reaching hard-to-reach populations. In September 2018, Mylan announced a partnership with Atomo Diagnostics, the manufacturer of the test, covering more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS), and Latin America.

WHO Prequalification (PQ) aims to ensure that diagnostics, medicines, vaccines, and immunization-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, to optimize use of health resources and improve health outcomes.

The prequalification process consists of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation, and site visits to manufacturers. This information, in conjunction with other procurement criteria, is used by UN and other procurement agencies, including PEPFAR and Global Fund, to make purchasing decisions regarding diagnostics, medicines and/or vaccines.

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