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."