Calypte Biomedical Facility Awarded ISO 9001 Certification.

Business Editors/Health & Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--March 27, 2001

Calypte Biomedical Corporation (Nasdaq:CALY) today announced that its Alameda, CA facility has received ISO 9001, EN 46001, and ISO 13485 certification. ISO certification is recognized for embracing the principles of best manufacturing practice used in the manufacture of a wide variety of products, including medical devices.

ISO (International Organization for Standardization) is a worldwide federation of national standards bodies from 130 countries. Its mission is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and developing cooperation in the spheres of intellectual, scientific, technological and economic activity.

Commenting on the certification, Nancy Katz, President, CEO and CFO of Calypte, said, "We are excited to have achieved this milestone, which paves the way for the expansion of Calypte's business throughout Europe. We are also pleased to receive global recognition for our dedication to high quality manufacturing processes. We continue to work toward obtaining approval of a CE-Mark Certification, which, along with ISO certification, will allow Calypte to market our products throughout the European Union based on approval from a single regulatory body. The CE-Mark is a product-specific stamp of approval, allowing manufacturers and exporters to permit the passage of products within the European Union, as well as to their customers in developing markets."

Calypte Biomedical Corporation (Nasdaq:CALY) 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 sells its products in over 40 countries worldwide through international distributors and strategic partners.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for new product developments, product development expenditures and shipments to 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, our ability to draw down funds under our existing equity line of credit and debenture agreements and whether demand for our product 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, including the periodic report on Form 10-K for the year ended December 31, 2000.