"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.
About AHF Global Immunity and the AIDS Healthcare Foundation (AHF)
The AHF Global Immunity program (AHF GI) is a non-profit, international initiative of AIDS Healthcare Foundation that works in partnership with local stakeholders to establish replicable, scalable and sustainable models for HIV/AIDS medical services delivery in resource-constrained settings throughout the world. The mission of AHF Global Immunity is to change the course of the HIV/AIDS epidemic by expanding access to life-sustaining ARV treatment for HIV positive people across the globe. AHF Global Immunity currently has clinics in South Africa (Durban); Uganda (Masaka, Mbale, Mpigi, Soroti, Rakai); Zambia (Chikankata); Honduras (San Pedro Sula, Siguatatpeque and Roatan); Mexico (Tijuana); India (Mysore & Koppal); and China (Yuncheng City, Shanxi province).
Established in 1987, AHF is the largest specialized provider of HIV/AIDS medical care in the United States and the nation's largest AIDS organization. AHF currently serves thousands of patients in the US regardless of their insurance status or ability to pay at fourteen outpatient clinics and one inpatient facility located in California and Florida. Under its AHF GI program, AHF also operates free AIDS treatment clinics providing life-saving care and antiretroviral treatment in Africa, Central America and Asia.
About Guava Technologies
Guava Technologies, Inc. is a leading provider of integrated, fully optimized microcapillary cytometry systems for many of the most important cell analysis applications. Guava's initial focus has been to serve the worldwide life science, biotechnology and pharmaceutical industries, offering a state-of-the-art, comprehensive portfolio of products designed to accelerate discovery and increase productivity with accessible, easy-to-use solutions for the biologist's testing problems, available right at the lab bench. Guava's products have broad applications in scientific research, drug discovery, cell counting, and optimization of commercial bio-production. The introduction of Guava's technology platform for clinical diagnostic use begins with the CD4 assays for HIV/AIDS monitoring in developing countries. Enormous potential also exists for other uses in clinical testing and blood processing and indeed any area where single cell counting and characterization is important.
The Guava PCA systems offer an integrated, optimized approach that takes the guesswork out of single cell analysis and counting. Based on patented microcapillary cytometry technology, the Guava PCA systems are available in several versions, to exactly meet the needs that exist in different laboratories. These cell analysis systems are flexible, highly affordable and ultra-compact, requiring only a few microliters of sample volume per assay, thus saving precious and expensive cells, reagents and compounds. Guava offers a variety of assays and dedicated software modules for the Guava PCA systems, enhancing the system's overall ease-of-use.
More information about the company and its products is available at www.guavatechnologies.com.
Guava and Guava Technologies are registered trademarks of Guava Technologies, Inc. EasyCD4 and PCA are trademarks of Guava Technologies, Inc.
Contacts:
Joan Kureczka
Kureczka/Martin Associates
415-821-2413
Jkureczka@comcast.net
For Europe:
Bill Bradbury, Primetek
WBPRIMETEK@aol.com
Louise Saufley
Guava Technologies, Inc.
510-576-1427
lsaufley@guavatechnologies.com
Ged Kenslea
Communications Director
AIDS Healthcare Foundation
gedk@aidshealth.org
1-323-860-5225 work
1-323-791-5526 mobile