AFRO-NETS> Calypte's Urine Based HIV Test Receives Approval in the Republic of Kenya

[Dr Rana Jawad Asghar <jawad@alumni.washington.edu>]

Calypte's Urine Based HIV Test Receives Approval in the Republic of Kenya
-------------------------------------------------------------------------
 
10/17/2003
 
Source: Calypte Biomedical Corporation
 
Calypte Biomedical Corporation (BULLETIN BOARD: CYPT), the devel-
oper and marketer of the only two FDA approved HIV-1 antibody 
tests that can be used on urine samples, as well as an FDA ap-
proved serum HIV-1 antibody Western blot supplemental test, an-
nounced that the Government of Kenya has stated that Calypte's 
urine testing is approved for importation, allowing Calypte the 
rights to distribute their urine based HIV-1 antibody tests and 
Western blot supplemental test into that Republic. The approval 
letter received by Calypte Biomedical was signed by Dr. Jack Nya-
mongo, Director of the Kenyan National Laboratory.
 
The National Aids Control Programme (NASCOP) of the Kenyan Minis-
try of Health formally met yesterday and announced that urine 
based HIV/AIDS testing, developed by Calypte Biomedical, is ap-
proved for distribution in Kenya. After extensive testing, NASCOP 
concluded that urine testing is a viable and safe method of test-
ing for HIV. Dr. Achala Ndinya, Senior HIV Co-Investigator in 
Kenya stated that "Calypte's urine test's sensitivity and speci-
ficity was very impressive in all 4 testing centers around the 
country, equaling the results of their preferred blood test." Dr. 
Ndinya also stated that he was "extremely pleased with the re-
sults and is looking forward to working with Calypte in the fight 
against HIV infection."
 
Calypte previously announced that they received a Letter of In-
tent from World Vision outlining a purchase of urine HIV tests. 
Subsequent to that announcement Calypte has learned that the pro-
curement for AIDS related testing and treatment are required to 
be routed through government agencies not through humanitarian 
organizations. As a result the Letter of Intent announced on Sep-
tember 16th has been cancelled. The success of the October 15th 
meeting with Kenyan's Ministry of Health now allows Calypte to 
transact the sale of its HIV/AIDS tests directly with the appro-
priate government agencies of the African Republics.
 
Jay Oyakawa, President of Calypte Biomedical stated, "After a 
rigorous and thorough testing process in Kenya, we are very 
pleased by the results and the official approval. This builds 
upon recent successes in Uganda and China where Calypte's urine 
testing maintains its high efficacy. A recent article in the East 
African pointed out that possibly 30% of HIV infected Africans 
received the virus through needles (International Association of 
Safe Needle Technology in Geneva, Switzerland). These results 
prove that urine testing is the viable alternative to needles."
 
Tony Cataldo, Chairman of the Board of Calypte Biomedical, said, 
"With this announcement Calypte shows yet again that urine test-
ing demonstrates the high efficacy which validates testing world-
wide. Urine testing is a cost effective and scientifically proven 
product which is a safe alternative to blood and needles."
 
About Calypte Biomedical:
 
Calypte Biomedical Corporation headquartered in Alameda, Califor-
nia, is a public healthcare company dedicated to the development 
and commercialization of urine-based diagnostic products and ser-
vices for Human Immunodeficiency Virus Type 1 (HIV-1), sexually 
transmitted diseases and other infectious diseases. Calypte's 
tests include the screening EIA and supplemental Western Blot 
tests, the only two FDA-approved HIV-1 antibody tests that can be 
used on urine samples. The company believes that accurate, non-
invasive urine-based testing methods for HIV and other infectious 
diseases may make important contributions to public health by 
helping to foster an environment in which testing may be done 
safely, economically, and painlessly. Calypte markets its prod-
ucts in countries worldwide through international distributors 
and strategic partners. Current product labeling including spe-
cific product performance claims can be found at:
http://www.calypte.com/
 
Statements in this press release that are not historical facts 
are forward-looking statements, including statements regarding 
announcements of financial results and presentations by the Com-
pany. Such statements reflect management's current views, are 
based on certain assumptions and involve risks and uncertainties. 
Actual results, events, or performance may differ materially from 
the above forward-looking statements due to a number of important 
factors, and will be dependent upon a variety of factors, includ-
ing, but not limited to, our ability to obtain additional financ-
ing that will allow us to continue our current and future opera-
tions and whether demand for our product and testing service in 
domestic and international markets will continue to expand. The 
Company undertakes no obligation to publicly update these for-
ward-looking statements to reflect events or circumstances that 
occur after the date hereof or to reflect any change in the Com-
pany's expectations with regard to these forward-looking state-
ments or the occurrence of unanticipated events. Factors that may 
impact the Company's success are more fully disclosed in the Com-
pany's most recent public filings with the U.S. Securities and 
Exchange Commission ("SEC"), including its annual report on Form 
10-K for the year ended December 31, 2002 and its subsequent fil-
ings with the SEC.
 
CONTACT: 
Investor Relations
Tim Clemensen for Calypte BiomedicalCorporation
Tel.: +1-212-843-9337
mailto:tclemensen@rubensteinir.com
http://www.calypte.com/
 
 
--
Dr Rana Jawad Asghar
Program Manager Child Survival, Mozambique
Provincial Coordinator Sofala Province, Mozambique
Health Alliance International, Seattle, WA, USA
http://depts.washington.edu/haiuw/
Coordinator South Asian Public Health Forum 
http://www.saphf.org
mailto:jawad@alumni.washington.edu 
http://www.DrJawad.com

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