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Zyomyx Point-of-Care CD4 Test Selected by CD4 Initiative to Help Treat HIV/AIDS Patients in Developing Countries
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Zyomyx's innovative approach enters final phase to become the world's first
low-cost, instrument-free test for measuring CD4 T-cell count in HIV/AIDS
patients
HAYWARD, Calif., Nov. 17 /PRNewswire/ -- Zyomyx, Inc., a leader in
chip-based bioanalysis technologies, today announced that its readerless
CD4 point-of-care (POC) technology was selected by Imperial College
London's CD4 Initiative as the best-performing POC test method for
measuring CD4 T-cell count in HIV/AIDS patients. Zyomyx's CD4 assay is now
the only remaining POC product being supported by the CD4 Initiative. With
this announcement, Zyomyx is currently entering the commercial phase of
this project and is actively soliciting partnerships with global sales and
distribution providers.
Zyomyx has developed the world's first, fully quantitative CD4 readout
in a POC format. As simple to read as a thermometer, Zyomyx's
patent-pending assay uses CD4-binding reagents to pull CD4 cells from a
blood sample and transfer them to a volumetric region of the device, where
cell count can be determined by a simple visual readout. The quantitative
CD4 count provides critical information in the clinical management of HIV.
The test will give doctors and patients in resource-poor settings with
limited infrastructure the same high-quality data that is available in the
rest of the world.
The CD4 Initiative was established in 2005 by an initial award of $8.6
million from the Bill & Melinda Gates Foundation and is conducted under the
aegis of the Imperial College London, UK. The Initiative's objective is to
develop a low-cost, instrument-free test for measuring CD4 T-cells in
HIV/AIDS patients. Throughout this year, the Initiative evaluated the three
remaining systems using clinical samples. Prototypes were assessed against
the predicate method of flow cytometry. Results from the verification trial
showed that only Zyomyx's CD4 test compared favorably with those generated
using the flow cytometry method.
"We are very pleased to confirm that the Zyomyx prototype not only
meets the original specifications of the Initiative, but has in fact
exceeded them," said Dr. Steven Reid, Project Manager of the CD4 Initiative
from the Division of Medicine at Imperial College London. "While the
original specification called for a simple cutoff test to determine whether
to begin treatment, the Zyomyx approach will go much further by delivering
a truly quantitative test which allows for both therapeutic monitoring as
well as treatment decisions."
"There has been a lot of progress increasing access to life-saving HIV
drugs in the developing world, but the lack of access to essential
diagnostics like a CD4 test is a major barrier to providing the best
possible care," said Dr. Hans-Georg Batz, Director and co-Founder of the
CD4 Initiative. "Zyomyx's new test will have a huge impact for people
living with HIV across the world. We are impressed by the innovation and
fast pace of product development at Zyomyx, and we look forward to working
with Zyomyx to finalize development and assist in getting their
point-of-care tests into the hands of healthcare workers."
"As innovators in the field of bioanalysis platforms, Zyomyx set out to
develop a point-of-care CD4 test that would arm healthcare workers with a
key tool in managing patients in need of antiretroviral therapy. I commend
our team for their hard work over the past few years, and also thank the
members of the CD4 Initiative for supporting this important project and
acknowledging and validating the Zyomyx approach," said Dr. Peter Wagner,
President and CEO of Zyomyx, Inc. "Now that we have achieved this
significant milestone, we are actively engaging with select global sales
and distribution partners who can help us take the Zyomyx test to market.
This includes additional cell count applications in diagnostics and life
science research beyond CD4 where an inexpensive, simple alternative to
flow cytometry is desired."
About Zyomyx
Zyomyx, Inc. is an innovator in bioanalysis platforms based on its
expertise in assay development, surface chemistry, and microsystem
technologies. The Zyomyx product development infrastructure and suite of
proprietary assay and surface technologies are ideally suited for the
robust development of advanced but simple and inexpensive diagnostics such
as the CD4 cell counting product.
Zyomyx is a privately held company and based in Hayward, Calif. For
more information about Zyomyx, please visit http://www.zyomyx.com.
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