Zyomyx's MyT4 point-of-care CD4 diagnostic test receives CE mark approval
Published on January 9, 2014 at 8:06 AM
Mylan, Inc. (Nasdaq: MYL) today announced that Zyomyx's MyT4™ point-of-care CD4 diagnostic test has received the CE Certificate of Conformity in the European Union, an important step toward launching this innovative test and expanding access to affordable, accessible and reliable diagnostics for people living with HIV globally. As a result, 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 agreement for the test in developing countries.
Mylan CEO Heather Bresch commented, "Mylan is proud to continue its commitment to setting new standards in health care by collaborating with Zyomyx on their MyT4™ test. 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, more than 28 million people living with HIV are in need of antiretroviral therapy treatment. Measuring a person's CD4 count provides an indication of the virus' impact on their immune system, and is a critical tool in staging and monitoring HIV patients. Significant barriers to routine CD4 measurement exist in developing countries, primarily because diagnostic equipment is available only in centralized laboratory facilities. The durable construction and rapid time-to-result of the MyT4™ test allow for its use in decentralized settings, such as rural communities, mitigating barriers posed by the limited availability of existing diagnostic devices.