Calypte Receives an Additional Approval Eliminating FDA Lot Release Testing; Reduces Production-to-Market Time for HIV-1 Urine Western Blot Test.

Business Editors/Health & Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--March 4, 2003

Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of the only two FDA-approved HIV-1 antibody tests that can be used on urine samples, today announced receipt of U.S. Food and Drug Administration (FDA) approval to eliminate the lot release testing requirement for the company's Cambridge Biotech HIV-1 Urine Western Blot test. On the heels of the company's January 8, 2003 approval eliminating FDA lot release testing for its HIV-1 Urine EIA test, this most recent approval is anticipated to reduce the production-to-market time by as much as two months for the urine Western Blot product as well as decrease associated production costs.

Nancy Katz, president and CEO of Calypte, stated, "We believe that the FDA, in eliminating the lot release testing for the company's Cambridge Biotech HIV-1 Urine Western Blot test, has again recognized Calypte's quality product manufacturing and performance. As they have recently done for our HIV-1 Urine EIA product, we believe the Agency's determination to eliminate product sample submission and testing in FDA laboratories prior to distribution for our Cambridge Biotech HIV-1 Urine Western Blot affirms our manufacturing and testing procedures, as well as our commitment to quality. It is anticipated that this lot testing elimination will improve our ability to efficiently manufacture products, ensure greater manufacturing and supply predictability, and to continue to satisfy growing product demand."

When the FDA approved the urine testing procedure for the Cambridge Biotech HIV-1 Western Blot in 1998 it was as a supplement to the already approved serum Western Blot product as a licensed biological product. This required the submission of every Western blot kit lot for testing in FDA laboratories first as a serum blot, and then again separately as a urine blot before product could be released for sale. Calypte secured a separate FDA pre-market approval (PMA) of the Urine Western Blot product as a Class III medical device in June 2001. After approval for the elimination of FDA lot release testing for the Urine EIA product, discussions with FDA led to the submission of a request for the elimination of lot release testing for the Urine Western Blot product. In issuing its approval, the FDA acknowledged the company's demonstration of long-term manufacturing consistency, successful establishment inspections and successful lot release testing.

About Calypte

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. 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 www.calypte.com.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, marketing arrangements and plans, and shipments to and regulatory approvals in international markets. 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 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/A (No.3) for the year ended December 31, 2001 and its subsequent filings with the SEC.