Global pharmaceutical company Mylan and medical device company Atomo Diagnostics have announced a strategic partnership to commercialize CE-Marked in vitro HIV rapid diagnostic tests for self-testing in low- and middle-income countries. The tests will allow individuals to confidently screen themselves in the privacy of their own homes with a device engineered for simplicity and accuracy. The tests are designed to detect the presence or absence of HIV antibodies in a single drop of blood obtained from a fingertip. Results are delivered in just 15 minutes, which is essential for access to early treatment and care.

While in some countries, like the U.S. and in Europe, HIV self-tests are readily available in pharmacies, HIV testing in low- and middle-income countries remains dependent on the diagnostic test being conducted in formal settings by trained professionals. Scaling up self-testing globally requires a simple and reliable product. Atomo is partnering with Mylan to supply all-in-one test devices that offer improved functionality and ease-of-use compared to current multi-component rapid diagnostic tests.

Under the terms of the agreement, Mylan has exclusive rights to commercialize the products in more than 100 countries in Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America. Mylan plans to launch the Mylan HIV Self-Test in global markets in early 2019.