HAYWARD, CA (April 27, 2005): Guava Technologies, Inc., a privately held biotechnology and medical device company, and AHF Global Immunity, an international initiative of AIDS Healthcare Foundation, the largest specialized provider of HIV/AIDS medical care in the United States, today announced a partnership aimed at increasing access in resource-limited nations to AIDS diagnosis and treatment monitoring. The partnership will initially focus on making Guava's EasyCD4TM system for direct, absolute CD4 T cell counts available at five sites in rural locations in Uganda and South Africa. Once the feasibility of using the Guava EasyCD4 system in these regions is demonstrated, AHF Global Immunity and Guava Technologies plan to cooperate in more broadly incorporating the Guava EasyCD4 testing system's use in HIV/AIDS clinics around the world.
"Accurate monitoring of CD4+ T lymphocyte levels in HIV infected individuals is a critical element for the use of anti-retroviral drugs, as it guides physicians in determining when to begin drug treatment and is a key measure of the effectiveness of that therapy," said Henry Chang, executive director, AHF Global Immunity. "With many resource-limited areas of the world now gaining access to more affordable anti-retroviral drugs, accurate but simpler, more portable and less costly methods of CD4+ testing are urgently needed. We are pleased to collaborate with Guava Technologies to bring such testing to several regions of Africa where the need is especially great."
"Until now, the cost of commercially available CD4 diagnostic testing for patient monitoring has remained very high, and access to affordable, accurate testing methods – especially in areas outside of major urban centers – very low," said Jeff Harvey, vice president of customer solutions at Guava Technologies. "Multi-site clinical studies suggest that CD4 T cell enumeration conducted on the Guava EasyCD4TM represents a good, significantly lower cost alternative to approved "gold-standard" flow cytometry methods. The Guava assays offer comparable accuracy and reproducibility to flow cytometry-based tests, but are much simpler and up to 20 times more affordable to use. Moreover, the Guava EasyCD4TM system offers the ability to provide a more comprehensive testing system, capable of running additional assays on its easy-to-use, benchtop instrument."
He noted that Guava was currently optimizing a CD4 percent assay, as well as developing viral load assay and other clinical tests for use on the Guava EasyCD4 system. A number of regulatory organizations around the world have indicated that new guidelines for HIV/AIDS diagnosis and monitoring will recommend the use of CD4 percent tests for monitoring pediatric HIV/AIDS patients.
About the Guava EasyCD4
The Guava EasyCD4 system and assay represent an optimized, integrated system of reagents, software and instrumentation. Guava Technologies' microcapillary cytometry technology enables the instrument to be highly compact, portable and low maintenance. Performance of the Guava assays is quite simple, with even novice users learning to use the EasyCD4 method in just a day or two. Testing requires only 10 microliters of whole blood per patient, making the method suitable for use in pediatric as well as adult patients. The Guava EasyCD4 assay also requires far less reagent per sample than other testing methods, dramatically lowering the overall costs of performing the assay. Moreover, the Guava EasyCD4 assay does not require nearly the amount of dedicated laboratory infrastructure. The system also does not require large amounts of buffered water as sheath fluid that are required by conventional flow cytometers. The elimination of the use of sheath fluid also results in less bio-hazardous waste and significantly further reduces the running costs of using the system. Daily maintenance is minimal – just a fast and easy 5 minute clean and shutdown procedure performed at the end of each day.
Guava is currently marketing the EasyCD4 system and assay in nations where the need is greatest, those outside of the United States, Europe and Japan. The Guava EasyCD4 system has not yet been cleared by the U.S. Food and Drug Administration for clinical laboratory use in the United States but the clearance process is underway.
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