Zyomyx Point-of-Care CD4 Test Selected by CD4 Initiative to Help Treat HIV/AIDS Patients in Developing Countries

By Zyomyx Inc., PRNE
Monday, November 16, 2009

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, California, November 17 - 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 US$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 www.zyomyx.com.

Leyl Master Black, +1-415-378-6395, leyl at marketingalchemist.com, for Zyomyx, Inc.

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