) Calypte HIV-1 Urine EIA exhibits strong performance in Brazilia - 500 Beiträge pro Seite

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(BSNS WIRE) Calypte HIV-1 Urine EIA exhibits strong performance in Brazilia
Calypte HIV-1 Urine EIA exhibits strong performance in Brazilian Study;
Correctly Identifies All Positives With Major HIV-1 Subtypes


Business Editors/Health & Medical Writers

ALAMEDA, Calif.--(BW HealthWire)--March 13, 2002--Calypte
Biomedical Corporation (OTCBB:CALY), a public healthcare company
dedicated to the development and commercialization of urine-based
diagnostic products and services, today announced that in a recently
completed Brazilian study Calypte`s HIV-1 Urine EIA achieved 100%
sensitivity, evidence that the urine EIA can detect the major HIV-1
subtypes in Brazil.
A large number of HIV-1 subtypes circulate in different parts of
Brazil. Patients in this study were shown to be infected with three
major subtypes (B, B" and F). All 76 patients identified as HIV-1
positive by blood testing were also shown to be repeatedly reactive
with the Calypte HIV-1 Urine EIA test.
In addition, the urine EIA correctly identified 278 of 284
negative samples for a specificity of 97.9%. According to common
practice, the six EIA repeatedly reactive specimens would subsequently
be subjected to the urine Western Blot assay for final interpretation
of the HIV-1 antibody status.
"Urine is an excellent alternative to blood for HIV antibody
detection due to the ease of collection without the need of special
devices as in saliva collection and the absence of infectious virus
particles," offered Dr. Walter Oelemann, one of the principal
investigators in this study. "Our results suggest that the Calypte
HIV-1 Urine EIA is a good screening test suitable for developing
countries like Brazil. As for all screening tests on the market, it is
not specific enough as a one-step test and therefore requires
confirmation".
"We are very pleased with the outcome of the study," said Dr. Toby
Gottfried, Chief Science Officer at Calypte. "These findings are
consistent with clinical and post market studies completed in the
United States for our urine test."
Outside of the United States, Brazil has the highest number of HIV
cases in the Western hemisphere. Calypte is currently pursuing the
registration of its urine HIV-1 assays in Brazil. Health authorities
in Brazil are determining the design of clinical studies for the
evaluation of the Calypte HIV-1 Urine EIA.
Full results will be published in an article titled "Diagnostic
Detection of Human Immunodeficiency Virus Type 1 Antibodies in Urine:
a Brazilian Study" in the March volume of the Journal of Clinical
Microbiology http://jcm.asm.org/cgi/content/abstract/40/3/881.

About Calypte Biomedical:

Calypte Biomedical Corporation headquartered in Alameda,
California, is a public healthcare company dedicated to the
development and commercialization of urine-based diagnostic products
and services 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 products in countries worldwide
through international distributors and strategic partners.
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 Company.
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, including, but not
limited to, our ability to obtain additional financing that will allow
us to continue our current and future operations 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 forward-looking statements to reflect events
or circumstances that occur after the date hereof or to reflect any
change in the Company`s expectations with regard to these
forward-looking statements or the occurrence of unanticipated events.
Factors that may impact the Company`s success are more fully disclosed
in the Company`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, 2001 and its subsequent filings
with the SEC.

--30--gm/sf*

CONTACT: Calypte Biomedical Corporation
Toby D. Gottfried, Ph.D., 510/749-5100
Dick VanMaanen, 909/279-8884
www.calypte.com

KEYWORD: CALIFORNIA BRAZIL INTERNATIONAL LATIN AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL PHARMACEUTICAL PRODUCT
SOURCE: Calypte Biomedical Corporation

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[V51]

Das ist die Revolution schlechthin. Aidstest per Urin, so wie Schwangerschaftstest.....das wird weggehen wie warme Semmeln.