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FOR
IMMEDIATE RELEASE
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 specialised 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.
Partnership
to bring low cost AIDS diagnosis and treatment monitoring to resource
limited countries ..
Guava
Technologies, Inc., a privately held biotechnology and medical device
company, and AHF Global Immunity, an international initiative of
AIDS Healthcare Foundation, the largest specialised 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 EasyCD4™ 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
EasyCD4™ 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 EasyCD4™ 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 optimising 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 organisations
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 optimised, 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 microlitres 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 specialised provider of
HIV/AIDS medical care in the United States and the nation's largest
AIDS organisation. 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 optimised
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.
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