Calypte Finalizes Manufacturing Agreement for Rapid Tests
Technology Transfer Scheduled for June ALAMEDA, Calif., May 11, 2004 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CYPT), a developer, manufacturer and marketer of HIV diagnostic tests, today announced that it has concluded a non-exclusive contract manufacturing agreement with Pacific Biotech Co. Ltd., a Thai diagnostics company located in Phetchaboon. Calypte announced on April 1, 2004 that the two companies had signed a Memorandum of Understanding for the manufacture of Calypte's rapid blood test for HIV-1+2 antibodies.
Dr. J. Richard George, President and CEO of Calypte stated that "HIV Vanguard(TM) BSP is a rapid test for the detection of HIV-1 and HIV-2 antibodies in finger stick whole blood, serum, and plasma samples. It is the first rapid HIV test from Calypte to go into production at Pacific Biotech, and we see this as just the beginning of a series of such technology transfers. The products manufactured at this facility are primarily intended to serve markets in Asia, excluding China, and Africa."
The technology transfer is scheduled to begin mid-June, and the first pilot production lots should be completed in Quarter 3 of 2004.
According to Dr. George, "Rapid tests like these are ideally suited to the needs of the developing world, where the prevalence of HIV is the greatest. These 20-minute tests are simple to perform and can be used in a wide variety of non-laboratory settings. We have designed these tests to provide the optimal combination of performance and economy, and future versions of the test will provide the added benefit of testing without the need for blood sampling."
About Pacific Biotech:
Pacific Biotech manufactures high quality diagnostic products to serve the healthcare market world wide on both an OEM basis and under its own brand. It has built a strong reputation for premium quality product and superb customer services for over a decade. Pacific Biotech products and services meet the Thai FDA compliance standards and ISO9001. With the strong support from the Board of Investment and National Science and Technology Development Agency, Pacific Biotech is a model of cooperation between the government and private sectors in promoting the development of a Thai biotechnology industry. Pacific Biotech's products are based on rapid immunochromatographic technologies, and include tests for reproductive hormones, drugs of abuse, and markers of infectious disease.
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 and CEO Tim Clemensen, (510) 749-5100 Rubenstein Public Relations email:rgeorge@calypte.com Phone: 212-843-9337 Email:tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
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 Public Relations, +1-212-843-9337, tclemensen@rubensteinir.com, for Calypte Biomedical Corporation
http://www.calypte.com
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