New lower-cost assay system equivalent to flow cytometry for accurate CD4+/CD8+ cell counts

HAYWARD, CA (July 12, 2004): Results from a multi-site study evaluating two new assays from Guava Technologies, Inc. that dramatically lower the cost and difficulty of AIDS diagnosis and treatment monitoring were presented Sunday at the 15th International AIDS Conference, held July 11 17 in Bangkok, Thailand. Data from three separate study sites showed that results obtained using the Guava EasyCD4 and EasyCD8 Assays for the enumeration of Human CD4+ T cells and CD8+ T cells showed excellent correlation with the standard, clinically approved BD MultiTESTTM (flow cytometry) assay. Moreover, assay reproducibility both within-site and between-sites for the Guava assays was excellent.

Study results were provided by investigators from the University of California, San Francisco (UCSF), the Gladstone Institute of Virology and Immunology, California Department of Health Services, and Guava Technologies, Inc. They were presented at the satellite symposium organized by the Forum for Collaborative HIV Research and entitled "HIV Monitoring Technologies for Resource-Limited Settings."

"With many resource-limited areas of the world now gaining access to more affordable anti-retroviral therapies, simpler and less costly methods of monitoring treatment including absolute CD4+ and CD8+ T cell counts are urgently needed," said Barry Bredt, Ph.D., director of core laboratories, General Clinical Research Center, UCSF/San Francisco General Hospital. "Our results suggest that the EasyCD4 and EasyCD8 assays represent good lower cost alternatives to approved flow cytometry methods of CD4+ and CD8+ T cell enumeration. The Guava assays offer comparable accuracy and reproducibility to the flow cytometry-based method, but are much simpler and more affordable to use."

Absolute CD4+ and CD8+ T cell counts are measurements used to monitor disease progression in HIV/AIDS patients, to determine when to begin treatment with antiretroviral drugs and to monitor


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