Calypte Biomedical Presents Results of Its Rapid HIV-1/2 Field Trial Tests at the XV International AIDS Conference in Bangkok
July 15 2004 - 2:23PM
PR Newswire (US)
Calypte Biomedical Presents Results of Its Rapid HIV-1/2 Field
Trial Tests at the XV International AIDS Conference in Bangkok
Overall Accuracy: Blood Rapid 100%, Oral Fluid Rapid 99.8%, Urine
Rapid 99.6% PLEASANTON, Calif., July 15 /PRNewswire-FirstCall/ --
Calypte Biomedical Corporation (OTC:CYPT) (BULLETIN BOARD: CYPT)
announced today that it has completed the initial field trials of
its rapid products currently under development and has distributed
that study data at the XV International AIDS Conference in Bangkok,
Thailand. The results are based on a statistically significant
number of patients conducted under a controlled clinical study at
the Thai Red Cross Anonymous HIV Clinic in Bangkok, Thailand. The
results are as follows: External validation trials of the Calypte
blood, oral fluid and blood rapid HIV antibody assays began in
April 2004 at the Thai Red Cross Anonymous HIV Clinic in Bangkok,
Thailand. This study was completed in June 2004 and results have
been provided to delegates of the XV International AIDS Conference
currently in progress in Bangkok. This study tested a total of 1023
subjects, 392 seropositive subjects, including 37 seropositive
subjects receiving anti-retroviral therapy, and 631 seronegative
subjects. The true antibody status of these subjects was determined
by testing of a blood sample using the standard testing method
routinely used by the Anonymous Clinic for diagnostic testing. The
Calypte blood rapid test was 100% concordant with the results of
the standard blood tests. The Calypte oral fluid test demonstrated
99.5% sensitivity (390/392). The two false negative results were
from two known positive subjects who were on anti-retroviral
therapy. These patients are known to have diminished antibody
levels and would not normally be seeking HIV diagnostic testing.
The specificity of the oral fluid test was 100%. The Calypte urine
assay was found to be 99.0% sensitive (388/392), 100% specific. The
blood, oral fluid, and urine tests correctly identified 1023/1023,
1021/1023, and 1019/1023 for an overall accuracy of 100%, 99.8%,
and 99.6%, respectively. "We are having a successful meeting at the
XV International AIDS Conference in Bangkok, Thailand this week,
presenting the results of our field trials of our Thailand studies
covering over 1,000 subjects," said Dr. Richard George, Calypte's
President and Chief Executive Officer. "I am very pleased with the
performance of these assays in their initial field testing. The
performance of the blood rapid test is on a par with the best
laboratory and rapid HIV antibody tests currently on the market.
The Calypte assays that test non-invasive alternative fluids showed
performance comparable to or better than other such assays
currently available. Even though we have other validation studies
either in progress or pending and we continue to improve these
assays, this study validates our decision to begin manufacturing
and commercialization of these assays for the international market.
We believe the availability of these safe, accurate, and economical
assays will increase the acceptance of HIV testing and will lead to
more people knowing their HIV status and being enrolled in
treatment programs." About Calypte Biomedical: Calypte Biomedical
Corporation, headquartered in Pleasanton, 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. Richard George,
Tim Clemensen, President and CEO Rubenstein Investor Relations
Phone: 925-730-7200 Phone: 212-843-9337 Email: Email: DATASOURCE:
Calypte Biomedical Corporation CONTACT: Dr. Richard George,
President and CEO, +1-925-730-7200, ; or Investor Relations - Tim
Clemensen of Rubenstein Investor Relations, +1-212-843-9337, Web
site: http://www.calypte.com/
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