Calypte Biomedical Corp. (ticker: CYPT.OB, exchange: Other OTC) News Release - 25-May-2004
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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 (OTC 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: rgeorge@calypte.com Email: tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
-0- 05/25/2004
/CONTACT: Dr. J. Richard George, President and CEO of Calypte Biomedical
Corporation, +1-510-749-5100, rgeorge@calypte.com, or Investor Relations - Tim
Clemensen of Rubenstein Investor Relations, +1-212-843-9337,
tclemensen@rubensteinir.com, for Calypte Biomedical Corporation/
/Web site: http://www.calypte.com /
(CYPT)
CO: Calypte Biomedical Corporation
ST: California
IN: MTC HEA BIO OTC
SU: PDT
JL
-- NYTU103 --
1279 05/25/2004 08:54 EDT http://www.prnewswire.com
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