Zyomyx Receives CE Mark for its new MyT4™ Point-of-Care CD4 Test

Zyomyx, Inc., a provider of innovative point-of-care diagnostic tests, has announced that it received the CE Mark for its MyT4™ point-of-care CD4 test. 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.

MyT4™ is the first of an expanding line of diagnostic tests that originate from Zyomyx’s portfolio of proprietary platform technologies capable of moving laboratory tests for cells, proteins and infectious agents to the point-of-care and thereby providing immediate benefits to clinicians, healthcare workers and patients in multiple disease areas.

Zyomyx, a vertically integrated diagnostics company, developed the MyT4™ test, secured its CE marking and expects to begin selling the product in 2014 from its Fremont manufacturing facility. As a true point-of-care solution, the 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 any maintenance or complex instrumentation.

“We are delighted to have met this regulatory milestone for MyT4™ and look forward to shipping our product this year” 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.”

According to the Joint United Nations Programme on HIV/AIDS, more than 28 million HIV/AIDS patients worldwide are receiving or in need of antiretroviral therapy. A major barrier to initiating and monitoring treatment for patients is the lack of access to CD4 testing because traditional lab-based flow cytometers are only available in centralized locations, requiring many patients to wait weeks to obtain a result. Zyomyx’s quantitative test will enable millions of HIV positive people to quickly receive a CD4 result and start lifesaving antiretroviral treatment without delay.