HIV virus being released from the surface of an infected cell. Credit: Bette Korber at Los Alamos National Laboratory.

Pharmaceutical company Mylan has formed a strategic alliance with medical device firm Atomo Diagnostics to boost access to HIV self-testing in low- and middle-income countries.

As part of the agreement, Mylan received exclusive rights for commercialisation of in-vitro HIV rapid diagnostic tests in more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America.

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HIV testing rates have improved but expanding access to the tests is still a challenge in certain countries.

“Through the new partnership, the companies will provide all-in-one test devices, which are designed to deliver better functionality and are easy to use compared to existing multi-component rapid diagnostic tests.”

Mylan noted that offering point-of-care self-tests in community-based settings can increase the proportion of people aware of their HIV status, in turn enabling treatment or prevention.

Through the new partnership, the companies will provide all-in-one test devices, which are designed to deliver better functionality and are easy to use compared to existing multi-component rapid diagnostic tests.

Mylan CEO Heather Bresch said: “Our partnership with Atomo to supply HIV rapid diagnostic tests for self-testing is an important step in our collective goal of preventing HIV infections and expanding treatment.”

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HIV Self Test by Atomo Diagnostics secured the European CE-Mark in October last year. The test is a qualitative immunoassay designed to detect antibodies to HIV type 1 and type 2 in human whole blood.

Atomo Diagnostics founder and CEO John Kelly said: “This strategic partnership will mean that the products designed by Atomo can be introduced to more than 100 countries, so that millions of people will have access to award-winning rapid tests.

“We believe that Mylan is the ideal partner to ensure that our HIV self-test products have maximum impact in the fight against HIV/AIDS.”

Mylan intends to globally launch the Mylan HIV Self-Test early next year.