Mylan, a global generic and specialty pharmaceuticals company, has announced that Zyomyx's MyT4 point-of-care CD4 diagnostic test has obtained CE Mark approval for the HIV diagnosis.
The CE Mark approval has been granted to Zyomyx’s MyT4 test following its compliance with stringent requirements related to the quality, safety, and performance of in vitro medical devices found in the applicable EU laws.
This approval is an important step for the company toward launching and expanding access to affordable, accessible and reliable diagnostics for people living with HIV globally.
Zyomyx is the manufacturer of the MyT4 CD4 diagnostic test. In July 2012, Zyomyx and Mylan have announced an distribution agreement for the test in developing countries.
The CD4 test is intended to rapidly identify the concentration of CD4 T-lymphocytes in patients with HIV/AIDS to assist in treatment initiation and drug monitoring.
Mylan CEO Heather Bresch noted the company 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," Bresch added.
According to Mylan, 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.