Calypte Biomedical Submits Investigational Device Exemption Application for HIV-1 Rapid Blood Test ALAMEDA, Calif., Nov. 6 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (BULLETIN BOARD: CYPT) , the developer and marketer of the only two FDA approved HIV-1 antibody tests for use with urine samples, announced today that it is submitting an application with the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) for its HIV-1 lateral flow antibody Rapid Blood Test to be performed on whole blood. This represents the Company's first application in connection with several rapid HIV diagnostic tests the Company has under development. The Company expects to submit a similar application for its urine-based HIV-1 Rapid Test sometime next year. "This application represents an important step in our attempt to penetrate the U.S. market for our suite of Rapid Test products," said Tony Cataldo, Calypte Biomedical's Chairman. "While we believe that near-term international opportunities for our Urine-based Rapid Test (once approved/commercially viable) will drive revenue growth, ultimately we feel that the North American market will represent a potential for substantial commercial opportunity for our Urine-based Rapid Test. We believe our ability to market a blood-based Rapid Test product will raise awareness among the U.S. medical community for our suite of Rapid Test products and ultimately shorten the sales cycle for our urine-based HIV product. In addition, we anticipate that there will be opportunities to cross-sell our blood related testing products to the medical community, as it acts as an excellent confirmatory test for urine." Under federal regulations, the FDA can authorize the use of an investigational test in the treatment of patients with serious or life-threatening conditions when no comparable or satisfactory alternative exists. The Company believes that its HIV-1 Rapid Blood Test may be cheaper than similar products currently being marketed in the U.S. About Calypte Biomedical Corporation 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, as well as an FDA-approved serum HIV-1 antibody Western Blot test. 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. Current product labeling including specific product performance claims can be found at http://www.calypte.com/. 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, our ability to obtain additional financing and access funds from our existing financing arrangements 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, 2002 and its subsequent filings with the SEC. CONTACT: Tim Clemensen, of Rubenstein IR, +1-212-843-9337, , for Calypte Biomedical Corporation DATASOURCE: Calypte Biomedical Corporation CONTACT: Tim Clemensen, of Rubenstein IR, +1-212-843-9337, , for Calypte Biomedical Corporation Web site: http://www.calypte.com/

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