Mylan Reports CE Mark For MyT4 Point-of-Care CD4 Diagnostic Test - Quick Facts

(RTTNews) - Mylan, Inc. (MYL) said that Zyomyx's MyT4 point-of-care CD4 diagnostic test has received the CE Certificate of Conformity in the European Union, a vital step towards launching this innovative test and expanding access to affordable, accessible and reliable diagnostics for people living with HIV globally.

Therefore, the MyT4 CD4 test can now bear the CE Mark, which demonstrates that the MyT4 CD4 test complies with stringent requirements related to the quality, safety, and performance of in vitro medical devices found in the applicable EU laws. Mylan and Zyomyx, the manufacturer of MyT4, announced in July 2013 their exclusive distribution deal for the test in developing countries.

Mylan CEO Heather Bresch commented, "The CE Mark for the MyT4™ test testifies to the exacting quality, safety and performance of this important diagnostic tool and we look forward to begin distributing it in the coming months."

According to the Joint United Nations Programme on HIV/AIDS, over 28 million people living with HIV are in need of antiretroviral therapy treatment.