Mylan HIV Self Test receives WHO prequalification approval

9 July 2019 (Last Updated July 9th, 2019 11:32)

Pharmaceutical company Mylan and medical device maker Atomo Diagnostics have secured the World Health Organization (WHO) prequalification approval for an in-vitro HIV rapid diagnostic meant for self-testing.

Mylan HIV Self Test receives WHO prequalification approval
HIV virus being released from the surface of an infected cell. Credit: Bette Korber at Los Alamos National Laboratory.

Pharmaceutical company Mylan and medical device maker Atomo Diagnostics have secured World Health Organization (WHO) prequalification approval for an in-vitro HIV rapid diagnostic meant for self-testing.

WHO prequalification is meant to ensure that medical products for high burden diseases meet global standards of quality, safety and efficacy for improving health outcomes and use of health resources.

Manufactured by Atomo Diagnostics, the handheld HIV Self Test has been designed to identify the presence or absence of HIV type 1 and type 2 antibodies via a fingerstick within 15 minutes.

The blood volume required by the qualitative immunoassay is said to be one-fifth of that used in existing tests.

Atomo Diagnostics makes the HIV diagnostic test available through specialist commercialisation partners. In Australia, the test is directly provided by the company.

Mylan collaborated with Atomo Diagnostics in September last year for exclusive commercialisation rights to the test in more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America.

The deal was intended to boost access to HIV self-testing in low and middle-income countries.

Desmond Tutu HIV Foundation executive director Linda-Gail Bekker said: “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.”

The HIV Self Test obtained the European CE-Mark in October last year.