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.

Zyomyx 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 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."

More information

The CD4 initiative at Imperial College
www1.imperial.ac.uk/medicine/about/divisions/medicine/
infectious_diseases/cd4_initiative/