Calypte Developing HIV-1/2 Oral Fluid Rapid Tests
May 25 2004 - 8:54AM
PR Newswire (US)
Calypte Developing HIV-1/2 Oral Fluid Rapid Tests Launch Expected
During Second Half Of 2004 ALAMEDA, Calif., May 25
/PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (BULLETIN
BOARD: CYPT) , a developer, manufacturer and marketer of HIV
diagnostic tests, today announced that it has developed a rapid
test for HIV-1/2 that can be performed on an oral fluid sample. HIV
results are available from the new Calypte Oral Fluid Test within
20 minutes. In-house evaluation of the rapid oral fluid assays
against commercial serum panels spiked into oral fluid at a
dilution that simulates actual oral fluid samples has shown to be
highly accurate with sensitivity comparable to most laboratory
based enzyme immunoassays. Specificity based on over 500 combined
samples from several sources was shown to be 99.8%. In addition,
the Calypte rapid oral fluid assay has been in an independent
clinical study at the Anonymous Clinic in Bangkok, Thailand for
more than a month and results are encouraging. Dr. Richard George,
President and CEO of Calypte stated that "HIV Vanguard (TM) OMT"
provides the final piece to the Calypte menu of tests that offers
the HIV testing community the opportunity to choose from a complete
line of rapid tests that can be used to test urine, oral fluid,
whole blood, and serum/plasma. Our blood rapid test is fully
validated and transfer of this technology to our manufacturing
partner is underway. Urine and oral fluid are in the final phases
of field testing and if testing continues at the current level of
performance, we expect that these tests will be ready for market in
the second half of 2004." Calypte has previously announced plans to
manufacture its rapid tests in China and Thailand. The Thailand
facility is expected to be in production by August of 2004. China
is expected to follow later in the 4th quarter of 2004. According
to Dr. George, "The projected addition of the rapid tests will
supplement our existing product lines that currently include
FDA-approved urine EIA, urine Western blot and serum Western blot
tests, as well as a novel HIV-1 incidence EIA test. Calypte
provides one of the most complete lines of HIV EIA tests available
from any single company." Current HIV/AIDS Testing: A May 2004
report by the Global Business Coalition on HIV/AIDS (GBC), based on
their own estimates and that of the World Health Organization
(WHO), disclosed that less than 10% of infected individuals in the
developing world know their HIV status. According to the report,
new infections are on the rise -- and only 400,000 of the 6 million
people in need of antiretroviral therapy have access to these life
saving medicines. Testing for HIV serves as an entry point for both
prevention and treatment. The objective of treating 3,000,000
people by the end of 2005, the stated goal of the WHO "3 by 5"
Initiative, would require that 500,000 people will need to be
tested each day. This is based on the report's estimate that 50,000
people will test positive in hard hit countries where the
prevalence rates average 10%, and that 10% or 5,000 per day of
those will require immediate initiation of treatment. GBC states
that the challenge is enormous but attainable with increases in
funding from donor governments, reductions in drug and diagnostic
pricing, integration of public-private delivery of healthcare and
overarching shifts in policy. Calypte will be part of a working
group with the GBC at the July 2004 XV International AIDS
Conference in Bangkok Thailand. About Calypte Biomedical: Calypte
Biomedical Corporation, headquartered in Alameda, California, is a
public healthcare company dedicated to the development and
commercialization of in vitro diagnostic tests, primarily for the
detection of antibodies to Human Immunodeficiency Virus (HIV), and
other sexually transmitted and infectious diseases. Calypte's
currently marketed laboratory-based tests include an enzyme
immunoassay (EIA) HIV-1 antibody screening test and an HIV-1
antibody western blot supplemental test, the only two FDA-approved
HIV-1 antibody tests for use on urine samples, as well as an
FDA-approved serum HIV- 1 antibody western blot supplemental test.
Calypte is actively engaged in developing new test products for the
rapid detection of HIV and other infectious diseases. Calypte
believes that there is a significant need for rapid detection of
such diseases globally to control their proliferation, particularly
in lesser-developed countries, which lack the medical
infrastructure to support laboratory-based testing. Calypte
believes that testing for HIV and other infectious diseases may
make important contributions to public health. Statements in this
press release that are not historical facts are forward-looking
statements within the meaning of the Securities Act of 1933, as
amended. Those statements include statements regarding the intent,
belief or current expectations of the Company and its management.
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, the Company's ability to obtain
additional financing and access funds from its existing financing
arrangements that will allow it to continue its current and future
operations and whether demand for its test products 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-KSB for the year
ended December 31, 2003 and its subsequent filings with the SEC.
Company Contact: Investor Relations Contact: Dr. J. Richard George,
President Tim Clemensen and CEO Rubenstein Investor Relations (510)
749-5100 Phone: 212-843-9337 email: Email: DATASOURCE: Calypte
Biomedical Corporation CONTACT: Dr. J. Richard George, President
and CEO of Calypte Biomedical Corporation, +1-510-749-5100, , or
Investor Relations - Tim Clemensen of Rubenstein Investor
Relations, +1-212-843-9337, , for Calypte Biomedical Corporation
Web site: http://www.calypte.com/
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