Zyomyx point-of-care test selected for initiative to treat HIV/AIDS
patients in developing countries
17 December 2009
Zyomyx, Inc. has announced that its readerless CD4
point-of-care (POC) technology was selected by Imperial College London’s
CD4 Initiative as the best-performing point-of-care 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.
has developed the world's first, fully quantitative CD4 readout in a POC
format (prototype shown on right). 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
"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
"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
The CD4 initiative at Imperial College