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Guava Technologies, Inc. Lowers the Cost of AIDS Diagnosis and Treatment Monitoring in Resource Poor Countries with the New EasyCD4 Assay System.

Business Editors/Health/Medical Writers

BIOWIRE2K

HAYWARD, Calif.--(BUSINESS WIRE)--May 5, 2004

Results Comparable to Standard CD4 Testing Methods with

Dramatically Lower Price, Greater Ease of Use

Medical laboratories in resource poor countries can now monitor direct, absolute CD4 (and CD8) T cell counts in HIV-infected patients faster, more easily and up to 20 times more affordably than ever before using the new EasyCD4(TM) system from Guava(R) Technologies, Inc. The Guava EasyCD4 system, which incorporates proprietary microcapillary cytometry technology, provides equivalent or superior results to established flow cytometry and manual microscopy methods of CD4 enumeration.

Guava Technologies today announced the commercial launch of the Guava EasyCD4 in nations outside of the United States, Europe and Japan. The company plans to introduce a version of the EasyCD4 system for research use only in the United States later in 2004, and will subsequently seek U.S. Food and Drug Administration approval for use of the system as a clinical diagnostic product.

"The absolute CD4 T cell count is an essential measurement used to monitor disease progression in HIV/AIDS patients, to determine the timing of treatment with anti-retroviral drugs, and to monitor a patient's response to treatment," said Rajen Dalal, chief executive officer, Guava Technologies. "Pharmaceutical companies have significantly lowered the cost of anti-retroviral therapies for resource-limited countries and the WHO has targeted treatment of 3 million infected individuals -- less than 10% of the infected HIV population -- by 2005. However the cost of commercially available CD4 diagnostic testing for patient monitoring has remained very high, and access to accurate testing very low. The Guava EasyCD4 system is a new, much more affordable and easy-to-use method of CD4 testing in a benchtop system that is reliable, robust, and provides results with excellent precision and accuracy."

The Guava EasyCD4 system is an optimized, integrated system of reagents, software and instrumentation. The use of Guava Technologies' microcapillary cytometry technology means the instrument is highly compact and portable and without the need for the large volumes of sheath fluid used in conventional flow cytometers or for a dedicated laboratory infrastructure. Operation is simple and turnkey, with even novice users learning to use the Guava EasyCD4 system in less than a day, eliminating the need for prolonged training. Testing requires only 10 microliters of reagents and of whole blood, which means less blood is required and less reagents are used, dramatically lowering the overall costs of performing the assay and making it highly suitable for use in pediatric as well as adult patients.

The elimination of the use of sheath fluid results in less bio-hazardous waste and further reduces the running costs of using the system. Moreover, daily maintenance is minimal -- just a fast and easy 5-minute clean and shutdown procedure performed at the end of each day. Service and support for the Guava EasyCD4 system is available around the world.

The company's collaborators at prominent HIV/AIDS research laboratories, including the U.S. Centers for Disease Control and Health Canada, among others, have rigorously tested the EasyCD4 assay against the established methods for performing absolute CD4 T cell counts. In every case, the Guava EasyCD4 system and assay method was proven to be equivalent or superior to those other methods. Moreover analysis shows that testing with the EasyCD4 assay is accurate and exhibits excellent reproducibility. Results of some of these studies, including the large multi-site trial performed at several of the leading HIV/AIDS research labs in North America, will be presented at various scientific fora, including The First Caribbean Workshop on Flow Cytometry -- Quality Control in HIV Monitoring and a Way Forward (Barbados, May 16-21, 2004), the XXII Congress of the International Society for Analytical Cytology (ISAC), (May 22-27, 2004 in Montpellier, France) and the XV International AIDS Conference (Bangkok, July 11-16, 2004).

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 serves 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 assay for HIV/AIDS monitoring in developing countries. There is also enormous potential for other uses in clinical testing and blood processing and any other 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, Inc. are registered trademarks of Guava Technologies, Inc. PCA and PCA-96 are trademarks of Guava Technologies, Inc.
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Date:May 5, 2004
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