New Point-of-Care CD4 Test Receives CE Marking

CE marking validation for the new test platform opens the way to highly accessible, reliable CD4 T-cell testing for HIV positive patients worldwide.

Zyomyx (Fremont, CA, USA) has now received the CE marking for its "MyT4" point-of-care CD4 test, intended to rapidly identify the concentration of CD4 T-lymphocytes in patients with HIV/AIDS and so to assist in decisions for treatment initiation and in drug monitoring. MyT4 is the first of an expanding line of diagnostic tests originating from Zyomyx's portfolio of proprietary platform technologies capable of moving laboratory tests for cells, proteins, and infectious agents to the point-of-care (POC) and thereby providing immediate benefits to clinicians and patients in multiple disease areas.

Zyomyx, a vertically integrated diagnostics company, developed the MyT4 test, secured its CE marking, and it expects to begin selling the product in 2014 in collaboration with Mylan, Inc. (Canonsburg, PA, USA) and the Bill & Melinda Gates Foundation (Seattle, WA, USA). As a POC solution, this quantitative test provides fast time-to-result—within minutes—and will be the only service-free test on the market, as it does not require maintenance or complex instrumentation.

"We are delighted to have met this regulatory milestone for MyT4," said Peter Wagner, President and CEO of Zyomyx; "The Zyomyx test is the fastest CD4 diagnostic on the market and delivers results that are equivalent to lab-based flow cytometry, the gold standard of CD4 testing. Zyomyx will continue to dedicate its efforts to bringing next-generation point-of-care diagnostic solutions to the market."

MyT4 is well configured to meet the needs of developing countries. For the millions of HIV/AIDS patients worldwide receiving or in need of antiretroviral therapy, a major barrier to initiating and monitoring treatment for patients is the lack of access to routine CD4 testing because flow cytometers are expensive, complex, and are only available in centralized locations, often requiring patients to wait weeks to obtain a result. Zyomyx's test will enable millions of HIV+ people to quickly receive reliable CD4 results and start or monitor lifesaving antiretroviral treatment without delay.

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