Zyomyx Receives CE Mark for Its New MyT4(TM) Point-of-Care CD4 Test
Validation of Point-of-Care Platform Paves the Way for Expanded Product
FREMONT, Calif., Jan. 9, 2014 (GLOBE NEWSWIRE) -- Zyomyx, Inc., a provider of
innovative point-of-care diagnostic tests, announced today that it received the
CE Mark for its MyT4(TM) 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(TM) 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(TM)
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
"We are delighted to have met this regulatory milestone for MyT4(TM) 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.
About Zyomyx, Inc.
Zyomyx, Inc., a privately held diagnostics company based in Fremont, California
is a developer, manufacturer and marketer of innovative point-of-care diagnostic
products. Its suite of proprietary assay, surface chemistry and device
technologies enables the development of fast and simple-to-use diagnostic
products, designed to improve health outcomes for patients. Zyomyx's first
product, an inexpensive CD4 T-cell point-of-care test that is configured to meet
the needs of developing countries, will be launched globally in 2014. For more
information, visit http://www.zyomyx.com.
CONTACT: Karen Schlein, 510-456-1749, firstname.lastname@example.org
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Source: Zyomyx via GlobeNewswire