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.

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.